Reported trial results for Hepatitis B

137 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT04749368 · results posted 23 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04749368) looked at a treatment approach for chronic hepatitis B (a long-term liver infection). Participants were divided into three groups: Cohort A (11 people), Cohort B (39 people), and Cohort C (41 people), giving a total of 91 participants. The trial was measuring whether participants could clear a specific protein linked to the hepatitis B virus (called HBsAg) from their blood after stopping a type of antiviral tablet, and it also tracked unwanted health events that occurred during the study. The reported data shows that when it came to the main goal — clearing HBsAg from the blood for a sustained period after stopping the antiviral tablets — zero participants in any of the three groups achieved this result. Similarly, at a later check-in point (week 72), the reported data shows that zero participants in any group had cleared HBsAg. Only one participant (in Cohort C) met the criteria that would have allowed them to stop their antiviral tablets at week 44. Regarding unwanted health events, the reported data shows that 10 out of 11 participants in Cohort A, 37 out of 39 in Cohort B, and 37 out of 41 in Cohort C experienced at least one adverse event (an unwanted health occurrence during the study). Serious adverse events were reported for 0 participants in Cohort A, 3 in Cohort B, and 6 in Cohort C. A small number of participants across all groups also had notable abnormalities in laboratory test results during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06422767 · results posted 10 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT06422767) enrolled 46 participants in total. They were divided into four groups: 5 people received four doses of bepirovirsen (an injectable medicine being studied for hepatitis B) under the skin, 5 received four dummy (placebo) injections, 18 received three doses of bepirovirsen, and 18 received three placebo injections. All 46 participants completed the study. The main thing the trial was measuring was whether bepirovirsen — given at higher-than-usual doses — affected the heart's electrical activity, specifically a measurement from a heart tracing (ECG) called the QTcF interval. A prolonged QTcF interval can sometimes be associated with heart rhythm concerns, so this type of measurement is a standard check in drug development. The reported data shows that for the primary measure — the estimated change in QTcF interval compared to placebo at the point of highest drug levels in the body — the four-dose bepirovirsen group showed a difference of approximately 2.36 milliseconds, and the three-dose group showed approximately 2.02 milliseconds. These are very small changes in the context of a heart tracing measurement. The reported data also shows that for the various secondary heart-tracing measures (such as the RR interval, which reflects the time between heartbeats, as well as PR interval and QRS duration — other standard segments of a heart tracing), the changes from starting values were small and varied across groups. Notably, no participants in any group were recorded as having outlier readings that crossed the pre-specified concern thresholds for QTcF, PR interval, or QRS duration, and no abnormal T-wave or U-wave changes were reported in the bepirovirsen groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04980482 · results posted 29 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04980482) enrolled 43 participants in an initial "lead-in" phase, who were then divided into four smaller groups (called Cohorts A1, A2, B1, and B2, with 12, 13, 8, and 10 participants respectively) for the main treatment phase. The trial was investigating a combination of an experimental medicine called AB-729 and another medicine called Peg-IFNα-2a in people with hepatitis B. The main thing the trial set out to measure was how often and how seriously participants experienced unwanted health events (called "treatment-emergent adverse events") during and after dosing, as well as any abnormal laboratory test results. The reported data shows that, looking at the number of participants who experienced these unwanted health events: in the lead-in group, 23 out of 43 participants had such an event reported; in Cohort A1, 11 out of 12; in Cohort A2, 11 out of 13; in Cohort B1, 8 out of 8; and in Cohort B2, 9 out of 10. The reported data also shows that no participants in any group stopped the treatment because of these events (discontinuations due to adverse events were reported as zero across all groups). Some additional numbers appear in the data — 4 in the lead-in group and 2 in Cohort A1 — however the data as submitted does not clearly label what these figures refer to, so it would not be appropriate to describe them further. The trial also listed several secondary things to measure — such as changes in hepatitis B surface antigen levels and other virus markers — but no numerical results for those measures were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04412863 · results posted 16 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04412863) enrolled 84 adults with chronic hepatitis B across six groups. Each group received a different combination or duration of two investigational treatments — a drug called VIR-2218 and/or a medicine called PEG-IFNα — while also continuing on standard background antiviral tablets (NRTIs). The groups ranged in size from 5 to 18 participants. The trial was primarily measuring how many people in each group experienced side effects or abnormal test results during treatment. The reported data shows that adverse events (unwanted health occurrences recorded during the trial) were counted in most participants across all groups: 9 of 15 in the first group, 13 of 15 in the second, 3 of 5 in the third, 16 of 18 in the fourth, 17 of 18 in the fifth, and 13 of 13 in the sixth. Abnormal readings in vital signs, heart tracings (ECGs), or laboratory tests were also recorded across groups, ranging from 2 to 14 participants per group depending on the type of abnormality measured. The trial also tracked a protein in the blood called HBsAg, which is a marker associated with hepatitis B. The reported data shows the average maximum reduction in this protein ranged from approximately 1.73 to 2.99 units (on a logarithmic scale) across the six groups. The number of participants whose HBsAg became undetectable at any point ranged from 0 to 6 per group, and those who maintained undetectable levels for more than six months ranged from 0 to 4 per group. A separate measure called anti-HBs seroconversion — where a certain protective marker appeared in the blood for the first time — was recorded in between 3 and 9 participants per group, though the data was not reported in a way that allows direct comparison between groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05763576 · results posted 22 January 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05763576) involved 60 people across nine groups. Twelve participants received a placebo, and the remaining 48 received varying doses of the study drug, RO7565020. The trial was split into two parts: Part 1a tested the drug in healthy volunteers across six groups (some receiving the drug by injection under the skin, others directly into the vein), and Part 2a tested it in people living with chronic hepatitis B (a long-term liver infection) across two groups. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events, or AEs) and serious adverse events (SAEs — meaning those that were life-threatening, required hospitalisation, or caused significant harm). It also looked at how quickly the drug reached its highest level in the bloodstream. The reported data shows that in the healthy volunteer groups (Part 1a), the number of participants who experienced any adverse event ranged from 1 to 6 people per group, out of 6 in each group (or 12 in the placebo group, of whom 6 experienced an AE). One serious adverse event was reported, in one person in Part 1a Cohort 4. In the chronic hepatitis B groups (Part 2a), 2 out of 6 participants in one group and 3 out of 6 in the other experienced adverse events, with no serious adverse events reported in either group. Across all groups — both healthy volunteers and hepatitis B participants — no participants experienced the specific "adverse events of special interest" being tracked, which included certain liver-related warning signs or suspected infection passed on by the study treatment. The reported data also shows how long it took the drug to reach its peak concentration in the blood. For groups who received the drug by injection under the skin, this ranged from about 7 to 17 days depending on the group and dose. For the two groups who received the drug directly into the vein, the peak was reached much faster — at around 2.1 hours in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05612581 · results posted 26 November 2025

  According to the results reported on ClinicalTrials.gov, this trial (which ran two related studies called STRIVE and THRIVE) looked at an experimental treatment approach for chronic hepatitis B — a viral liver infection. The trial tested combinations of investigational drugs (VIR-3434, VIR-2218, and/or PEG-IFNα) alongside an existing antiviral medicine called TDF (tenofovir disoproxil fumarate). The trial was organised into several groups, but based on the submitted data, only two groups had participants recorded: one group in the THRIVE study (Cohort 4a, testing VIR-3434 + VIR-2218 + TDF) with 16 people who started and 11 who completed, and another THRIVE group (Cohort 2b, testing VIR-3434 + VIR-2218 + TDF) with 17 people who both started and completed. The remaining groups all show zero participants in the reported data. The reported data shows that the main thing being measured was the number of participants who, by the end of treatment, had two things happen at the same time: their hepatitis B virus levels in the blood dropping below a detectable threshold, and a protein associated with the virus (called HBsAg, a marker of the infection) falling to a very low level. According to the results reported on ClinicalTrials.gov, 1 out of 16 participants in the STRIVE Cohort 4a group, and 4 out of 17 participants in the THRIVE Cohort 2b group, met both of these targets by the end of treatment. For all other groups, no measurement data was reported. The reported data for the secondary outcomes — including side effects, and HBsAg levels at various other time points — was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04297917 · results posted 12 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04297917) enrolled 47 participants across six groups. Five healthy volunteers received a low dose of the vaccine, five received a high dose, six people living with chronic hepatitis B received a low dose, and five received a high dose. Additionally, 15 healthy volunteers who had previously received the AstraZeneca (AZD1222) COVID-19 vaccine and 11 who had previously received a Pfizer or Moderna COVID-19 vaccine each received the high dose. The trial was primarily measuring reactions and unwanted events following vaccination, and — for the hepatitis B participants — also tracking a marker in the blood called HBsAg (a protein associated with the hepatitis B virus). The reported data shows that no participants in any group experienced a serious adverse event (an unexpected or severe medical event) that was related to the study vaccine. No participants experienced severe local reactions (such as significant redness or swelling at the injection site) rated Grade 3 or above. One participant in the high-dose healthy volunteer group experienced a severe whole-body reaction (such as fever or fatigue) rated Grade 3 or above; no other group reported any. Across all groups, between 1 and 8 participants per group experienced at least one adverse event of any kind, and none of these led to anyone leaving the study, except for one participant in the high-dose healthy volunteer group. For the primary outcome measuring CD8+ T cell responses (a type of immune cell activity), no numerical results were reported in the submitted data. The reported data for the hepatitis B participants shows changes in HBsAg blood levels were measured at four follow-up points (Day 28, 56, 84, and 168). These are expressed as a ratio — a number above 1 would suggest a reduction in the marker compared to the start. For the low-dose hepatitis B group, the ratios at those four time points were approximately 1.02, 1.09, 0.98, and 1.42. For the high-dose hepatitis B group, the ratios were approximately 0.96, 0.81, 0.90, and 1.06. These are the numbers as submitted; what they mean in a clinical sense is not for this summary to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04891770 · results posted 24 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04891770) enrolled 103 people with chronic hepatitis B infection across three groups. Cohort 1 (42 people) received four treatments together: TAF, VIR-2218, selgantolimod (SLGN), and nivolumab. Cohort 2 Group A (40 people) received VIR-2218, SLGN, and nivolumab. Cohort 2 Group B (21 people) received SLGN and nivolumab only. The trial's main goal was to measure how many participants achieved what researchers called a "functional cure" — defined as losing a specific hepatitis B protein from the blood (called HBsAg) while also having the hepatitis B virus fall below a detectable level, both measured at 24 weeks after treatment ended. The reported data shows that very few participants met the primary "functional cure" definition. Approximately 2.4% of Cohort 1, 2.5% of Cohort 2 Group A, and 0% of Cohort 2 Group B reached this outcome. For the secondary outcomes, the reported data shows that none of the participants across all three groups achieved HBsAg loss (with or without producing protective antibodies against HBsAg) at any point during the study. Among participants who were positive for another hepatitis B marker (HBeAg) at the start, small percentages lost that marker during the study — reported as 5.6% in Cohort 1 and 0% in both Cohort 2 groups — while 11.1% of Cohort 1 and 6.3% of Cohort 2 Group A went on to develop the corresponding protective antibody. The reported data also shows that the percentage of participants who remained off their usual antiviral tablets (called NUC treatments) during follow-up was 16.7% in Cohort 1, 55.6% in Cohort 2 Group A, and 75.0% in Cohort 2 Group B. Separately, a rebound in the virus during treatment (called "virologic breakthrough") was reported in 7.1% of Cohort 1, 35.0% of Cohort 2 Group A, and 20.0% of Cohort 2 Group B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02476695 · results posted 5 March 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 412 people with chronic hepatitis B. The study was measuring how well a non-invasive scanning device called FibroTouch could detect different stages of liver scarring (known as fibrosis), compared to a liver tissue sample (biopsy), which was used as the reference standard. Of the 412 participants, 11 had no fibrosis (F0), 162 had stage F1, 118 had stage F2, 95 had stage F3, and 26 had the most advanced stage (F4). All 412 participants completed the study. The reported data shows how accurately the FibroTouch device's liver stiffness measurement (LSM) distinguished between fibrosis stages. This was measured using something called an "area under the curve" (AUC) score — a number between 0 and 1 where a score closer to 1 suggests the measurement lines up more closely with the biopsy result. The reported AUC scores were 0.846 for detecting any fibrosis (stage F1 or above), 0.850 for stage F2 or above, 0.908 for stage F3 or above, and 0.874 for the most advanced stage (F4). The reported data also shows the stiffness readings (in kilopascals, a unit of pressure) that corresponded to each stage threshold: 5.5 kPa for F1 or above, 7.85 kPa for F2 or above, 10.0 kPa for F3 or above, and 12.7 kPa for F4. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04544956 · results posted 19 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a 300 mg dose of the investigational drug GSK3228836 (also known as bepirovirsen). Eleven of the 12 participants completed the study, while one did not. The trial was measuring changes in blood markers related to hepatitis B — specifically a protein called HBsAg (hepatitis B surface antigen) and the virus's genetic material (HBV DNA). The aim was to see how many participants reached levels of these markers that were too low to be detected by the tests used, which researchers describe as falling below the "lower limit of quantitation" (LLOQ — the lowest amount a test can reliably measure). The reported data shows that, at the main measurement point, 25% of participants (roughly 3 out of 12) had HBsAg levels that were too low to detect. Looking at different time points across the study, the reported rate of undetectable HBsAg ranged from 0% to 30%, depending on when it was measured. For HBV DNA (the virus's genetic material), the reported data shows that between 78% and 100% of participants had undetectable levels at various time points. When both markers were measured together at those same time points, between 0% and 20% of participants had both at undetectable levels. For the follow-up period — checking whether these low levels were maintained for 24 weeks after treatment ended — the reported data shows that 8% of participants met that definition, both for HBsAg alone and for both markers together. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04398706 · results posted 12 November 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04398706) tested three experimental pneumococcal vaccines — called SP0202-IIb, SP0202-VI, and SP0202-VII — and compared them to an already-approved vaccine called Prevnar 13. The trial ran in two stages: a smaller Stage I with 35 children in each of the four groups (140 in total), and a larger Stage II with roughly 176–179 children per group (712 in total). Across both stages, the trial enrolled 852 participants in all. The study was primarily focused on tracking various types of reactions and health events that occurred after vaccination, and also measured the level of immune proteins (called antibodies) produced in response to the vaccines in the toddler groups. The reported data shows that, in terms of reactions in the 30 minutes immediately after vaccination, zero participants across all eight groups reported any such event. For reactions at the injection site (such as tenderness, redness, or swelling), the numbers ranged from 13 to 21 participants in Stage I and from 119 to 128 in Stage II, across all vaccine groups including the comparison vaccine. For whole-body reactions such as fever, irritability, or vomiting, the reported numbers ranged from 23 to 27 in Stage I and 137 to 143 in Stage II across the groups. Unexpected, unplanned health events after vaccination were reported in 3 to 7 participants per group in Stage I and 116 to 122 per group in Stage II. Serious health events or special events of particular concern were reported in 0 to 1 participants per group in Stage I and 3 to 9 per group in Stage II. For the toddler antibody measurements (Stage I only), the reported data shows antibody levels varied across the vaccine types and the different parts of the vaccine being measured, with figures ranging from approximately 0.77 to 3.80 micrograms per millilitre depending on the group and the specific vaccine component; not all serotype-by-group figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04535544 · results posted 6 November 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04535544) looked at a treatment called JNJ-73763989 combined with a standard hepatitis B antiviral medicine (called a nucleos(t)ide analogue, or NA) in people with chronic hepatitis D virus (HDV) infection. The trial was run in two parts. Part 1 enrolled 22 participants (17 receiving JNJ-73763989 plus NA, and 5 receiving a placebo plus NA). Part 2 enrolled 30 participants (24 receiving JNJ-73763989 plus NA, and 6 receiving placebo plus NA). The trial included a double-blind phase (up to about one year, where neither doctors nor patients knew who received which treatment), an open-label phase (up to about three years, where the treatment given was known), and a follow-up period. The main thing being measured was whether participants showed a meaningful reduction in the amount of HDV virus in their blood — specifically a drop of at least 2 log10 IU/mL (a way of expressing a large reduction in virus levels) or having the virus become undetectable — alongside a return to normal liver enzyme (ALT) levels, all assessed at 48 weeks. The reported data shows that in Part 1 at Week 48, approximately 23.5% of participants in the JNJ-73763989 plus NA group met this combined target, compared with 0.0% in the placebo plus NA group. In Part 2 at Week 48, approximately 27.1% of participants in the JNJ-73763989 plus NA group met the combined target, again compared with 0.0% in the placebo plus NA group. These figures were calculated using a statistical method to account for missing data from participants who did not complete the measurements. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02952924 · results posted 31 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02952924) tested an investigational drug called RO7049389 and enrolled a total of 187 participants across multiple groups. The study was divided into several parts: some participants received single doses of the drug (to see how the body handles it after one dose), some received multiple doses over time, and others took part in proof-of-mechanism and additional cohort stages. A number of participants in each group received a placebo (a dummy treatment with no active ingredient) for comparison. The vast majority of participants completed the study, with only four people across all groups not finishing. The reported data shows that one set of primary measurements tracked the percentage of participants in Part 1 who experienced any adverse events (unexpected health changes noted during the trial). Among the placebo groups, 27.3% (single dose placebo) and 60.0% (multiple dose placebo) of participants had an adverse event recorded. Among those receiving the active drug, the reported percentages ranged from 16.7% in one group up to 100% in another, depending on the dose group — though the data does not break down what those events were or how serious they were. The trial also measured how the drug moved through the body — specifically, how quickly it reached its peak level in the blood (reported as between 1.25 and 3.0 hours across dose groups), what that peak blood level was (ranging from 250 to 24,800 ng/mL), how long it took for half the drug to leave the body (roughly 3.3 to 12.4 hours), and the overall amount of drug the body was exposed to over time (reported across a wide range depending on dose and whether participants had eaten beforehand). The reported data also shows that eating a meal before taking the drug appeared to be associated with higher peak blood levels and greater overall exposure compared with taking it on an empty stomach, based on the figures recorded for the food effect cohort. These numbers describe what was measured and observed during the trial only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04423393 · results posted 8 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04423393) tested a drug called VIR-3434 across four parts (Parts A–D), involving a total of 113 participants. Part A included healthy volunteers who received different doses of VIR-3434 either as an injection under the skin (subcutaneous, or SC) or directly into a vein (intravenous, or IV), or a placebo (a dummy treatment with no active ingredient). Parts B, C, and D included people living with hepatitis B virus (HBV) who also received varying doses by injection or placebo. The trial was measuring how often participants experienced unexpected health events (called adverse events) or unusual changes in their blood test results, and also tracking how the drug moved through the body over time. The reported data shows that, for the primary outcomes — that is, the main things being tracked — the number of participants who experienced treatment-emergent adverse events (health events that appeared after receiving the study drug or placebo) ranged from 2 to 6 out of 6–11 participants depending on the group, across Parts A and B. Data for Parts C and D were not reported for this outcome. For unusual laboratory (blood test) results, the numbers ranged from 0 to 2 participants per group in Parts A and B, with the remainder showing zero. Regarding how the drug behaved in the body (the secondary outcomes), the reported data shows that the peak level of VIR-3434 detected in the blood ranged from 352 to 26,100 nanograms per millilitre across the HBV groups, depending on the dose. The time it took to reach that peak ranged from roughly 3 to 7 days for injected doses. The reported "half-life" — meaning the time it took for the drug level in the blood to fall by half — ranged from approximately 3.6 to 13.6 days in the HBV groups and from about 20.7 to 28.5 days in the healthy volunteer groups. Tmax and half-life data for Parts C and D were partially reported; some group-level figures were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04778904 · results posted 13 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04778904) enrolled 55 people with chronic hepatitis B infection across four groups. Group 1 (10 people) received a vaccine called MVA-HBV on its own. Group 2 (18 people) received a combination of two vaccines, ChAdOx1-HBV followed by MVA-HBV. Group 3 (18 people) received the same two-vaccine combination plus a drug called nivolumab. Group 4 (9 people) received both vaccines together with nivolumab given alongside each one. The trial was primarily measuring how often participants experienced adverse events (unwanted health changes that occurred after receiving the study treatments), including how many of those were serious or severe. The reported data shows the following counts of participants who experienced adverse events of various kinds. For serious or severe (Grade 3 or higher — meaning notably significant) vaccine-related adverse events, 1 participant was recorded in each of Groups 1, 2, and 4, and 2 participants in Group 3. For severe adverse events specifically related to nivolumab, 1 participant in Group 3 was recorded, and none in the other groups. For special-interest adverse events — a pre-defined list of specific concerns such as lung inflammation, thyroid problems, or immune-related reactions — 2 participants in Group 3 were recorded, and none in the other groups. For all treatment-emergent adverse events (any unwanted health change occurring after receiving the study treatment), 6 participants in Group 1, 8 in Group 2, 11 in Group 3, and 4 in Group 4 were recorded. Potentially significant abnormal laboratory test results were reported in 2 participants in Group 3 and none in the others, while potentially significant abnormal vital signs (such as blood pressure or heart rate) were reported in 1 participant in Group 3 and none in the others. The reported data also shows that the vast majority of participants completed the study: 9 of 10 in Group 1, all 18 in Group 2, 17 of 18 in Group 3, and all 9 in Group 4. Secondary outcome data was not reported in the results submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03934736 · results posted 9 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03934736) enrolled 119 people who received a hepatitis B vaccine called HEPLISAV-B. Of those, 86 completed the trial and 33 did not. The trial was measuring two main things: how many participants developed a protective level of antibodies against hepatitis B (a sign that the immune system had responded to the vaccine), and how many experienced certain types of adverse events (unwanted health effects), including those serious enough to require a doctor's visit or hospitalisation. The reported data shows that, by the end of the study, 89.3% of participants had reached what the researchers defined as a "seroprotective" level of antibodies — meaning their blood showed an antibody level at or above the threshold the researchers set (10 mIU/mL, a standard unit used to measure antibody strength). Looking at how this built up over time, the reported figures at four different time points were 20.3%, 56.8%, 78.7%, and finally 89.3%. For a higher antibody threshold (100 mIU/mL), the reported percentages across the same time points were 5.4%, 33.8%, 57.3%, and 81.3%. On adverse events, the reported data shows that 66.4% of participants experienced a medically attended adverse event (meaning they sought medical care for it), 48.7% experienced a serious adverse event (as defined by the US FDA), and 0.8% experienced an immune-related adverse event of special interest. The reported data also tracked the average antibody concentration across the group over time, rising from 4.4 mIU/mL at the first time point to 33.5, then 155.3, and reaching 1,061.8 mIU/mL at the final measurement. These numbers describe the group's average antibody levels at each stage, not any individual's result. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04456504 · results posted 3 July 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 49 healthcare workers who had previously not responded to five or more doses of the standard hepatitis B vaccine (the type that uses an aluminium adjuvant — a substance added to vaccines to boost the body's reaction). The trial was measuring whether these same people would produce a measurable immune response — specifically, a blood antibody level above a set threshold — after receiving a different hepatitis B vaccine that uses a different booster ingredient called CpG adjuvant, given as a two-dose course. The reported data shows that out of 47 participants who completed the full two-dose series, 43 reached the antibody level considered a response. For the secondary question — whether a single dose alone was enough to reach that level — the reported data shows 41 out of the participants achieved it after just the first dose. The trial also looked at whether certain personal characteristics (age, smoking, sex, diabetes, or a weakened immune system) were linked to still not responding. The reported data shows that among those who did not respond, 3 participants had diabetes and 1 had a condition affecting their immune system, while zero non-responders were recorded for the other risk factors (age category, smoking, and sex as listed); however, the data as submitted does not provide a full breakdown of how these figures were analysed across the whole group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03365947 · results posted 4 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03365947) tested an investigational treatment called ARO-HBV (also known as JNJ-3989) for chronic hepatitis B virus infection. A total of 120 people took part across 19 different groups, receiving either varying doses of ARO-HBV — given at different dosing intervals and in some cases combined with another investigational medicine — or a placebo (an inactive treatment used for comparison). The trial was primarily measuring how many participants experienced unwanted medical events that were thought to be possibly or probably linked to the study treatment, and secondarily measuring how the drug moved through the body (what is known as pharmacokinetics — essentially tracking how much of the drug was in participants' blood and how quickly it peaked and cleared). The reported data shows that, for the primary outcome, the number of participants who experienced treatment-related unwanted medical events varied across groups. In the five groups receiving single doses of ARO-HBV (35 mg to 400 mg), one participant in each group reported such an event, compared with five out of ten in the placebo group. Among the multiple-dose groups, the numbers ranged from one to five participants per group. No data for this outcome were reported for several of the groups. The reported data also shows, for the secondary pharmacokinetics outcomes, that the peak level of ARO-HBV detected in the blood rose with increasing doses — for example, the highest recorded peak concentration in the single-dose groups went from 160 ng/mL at the lowest dose (35 mg) up to 4,280 ng/mL at the highest dose (400 mg). The time taken to reach that peak level was broadly consistent across dose groups, at around 6 hours. Measures of overall drug exposure in the blood also increased with higher doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04535037 · results posted 27 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04535037) enrolled 500 infants — 249 in the Infanrix Hexa group and 251 in the Vaxelis group. The trial was measuring the levels of a specific antibody (called anti-PRP) in children's blood at around 11 months of age, after they had received a booster dose of one of these two combination childhood vaccines. Anti-PRP is an antibody that the body makes in response to the Haemophilus influenzae type b (Hib) component of these vaccines. The study tracked how high antibody levels rose and what proportion of children reached certain pre-set antibody thresholds. The reported data shows that, looking at the main (primary) results at Month 11, the average antibody level (expressed as a geometric mean concentration — roughly, a type of average suited to this kind of data) was 11.61 µg/mL in the Infanrix Hexa group and 12.66 µg/mL in the Vaxelis group. The proportion of children whose antibody levels reached or exceeded 5 µg/mL was reported as 75.4% in the Infanrix Hexa group and 81.7% in the Vaxelis group. A second analysis using a slightly different grouping of participants produced very similar figures (11.26 vs 12.85 µg/mL; 75.4% vs 81.6%). The reported data also shows secondary measurements taken at earlier time points across the study. For a lower antibody threshold (0.15 µg/mL, described in the data as a short-term protection marker), the percentages of children reaching that level varied across time points — ranging from 61.2% to 99.5% in the Infanrix Hexa group and from 94.4% to 100% in the Vaxelis group. For a higher threshold (1.0 µg/mL, described as a long-term protection marker), the Infanrix Hexa group ranged from 13.1% to 97.2% across time points, while the Vaxelis group ranged from 69.0% to 94.5%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02956850 · results posted 8 February 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02956850) enrolled a total of 170 participants across two main parts. Part 1 involved healthy volunteers who received either a single dose or multiple doses of the study drug RO7020531 (or a placebo), tested across several dose levels. Part 2 involved people living with chronic hepatitis B, again receiving either the study drug or a placebo across different dosing groups. All but one participant completed the trial. The trial was measuring how often participants experienced any adverse events (that is, any unwanted medical occurrence — such as symptoms, signs, or abnormal test results — noticed during the study period), as well as how the drug moved through the body over time. The reported data shows the following for adverse events (the percentage of participants in each group who experienced at least one adverse event): In the single-dose healthy volunteer groups, the placebo group reported 31.3%, and the active-dose groups ranged from 25.0% to 50.0%. In the multiple-dose healthy volunteer groups, the placebo group reported 83.3%, and the active-dose groups reported 75.0% to 87.5%. In the hepatitis B patient groups, the placebo groups reported 50.0% and 60.0%, while the active-dose groups reported 68.8%, 75.0%, and 80.0%. The reported data also shows measurements of how much of the drug and its breakdown products appeared in participants' blood and how quickly those levels peaked, across the different dose groups, with figures varying depending on the dose level given. These numbers are technical tracking measurements rather than measures of how well the drug worked. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04820686 · results posted 14 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04820686) enrolled 65 people with hepatitis B across three treatment groups: 32 people received a combination of three treatments (vebicorvir, known as VBR, plus AB-729, plus a standard antiviral medicine); 16 people received VBR plus the standard antiviral; and 17 people received AB-729 plus the standard antiviral. The trial was measuring how these different drug combinations behaved in participants, including how many people experienced unwanted health events, abnormal lab results, or had to stop treatment early. Only 2 of the 65 participants were recorded as having fully completed the study. The reported data shows that in the group taking all three medicines, 26 out of 32 participants experienced one or more adverse events (unexpected health changes noted during the trial), compared with 12 out of 16 in the VBR plus standard antiviral group, and 12 out of 17 in the AB-729 plus standard antiviral group. When it came to stopping treatment early because of these events, the reported numbers were 3 people in the three-medicine group, 1 in the VBR plus standard antiviral group, and 0 in the AB-729 plus standard antiviral group. Abnormal laboratory results were recorded in 30 out of 32 participants in the three-medicine group, 16 out of 16 in the VBR plus standard antiviral group, and 16 out of 17 in the AB-729 plus standard antiviral group. The reported data also tracked changes in a specific hepatitis B protein in the blood (called HBsAg) over time, where a lower number indicates less of the protein present. By the latest reported time point, the average change from the starting level was −1.2 in the three-medicine group, 0 (no change) in the VBR plus standard antiviral group, and −1.1 in the AB-729 plus standard antiviral group. For two other secondary measures — the number of participants whose HBsAg dropped below a detectable level, and the number whose hepatitis B virus was undetectable in the blood — no figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04781647 · results posted 6 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04781647) enrolled 54 people with hepatitis B, split across three treatment groups: 20 people received ABI-H0731 combined with entecavir (a standard antiviral tablet); 17 received ABI-H0731 with entecavir plus pegylated-interferon alpha (an immune-stimulating injection); and 17 received entecavir plus pegylated-interferon alpha only. The trial was primarily measuring how many participants experienced unwanted health events (called adverse events), unusual laboratory test results, or stopped treatment early. It also tracked changes in three markers of the hepatitis B virus measured in blood — viral genetic material (pgRNA), the amount of virus present (DNA), and a viral protein (HBeAg). The reported data shows that when it came to the primary measures, adverse events were recorded in 14 of 20 participants in the first group, all 17 in the second group, and all 17 in the third group. Laboratory abnormalities were recorded in 19 of 20 in the first group, 16 of 17 in the second, and 17 of 17 in the third. Early treatment discontinuation was reported in 18 of 20 in the first group, 17 of 17 in the second, and 11 of 17 in the third. It is also worth noting that only 6, 5, and 6 participants respectively completed the full study period out of those who started. The reported data shows that across all three groups, the blood markers for hepatitis B (pgRNA, DNA, and HBeAg) showed reductions from their starting levels over the course of the study, with measurements taken at multiple time points showing progressively larger reductions as time went on. The numbers represent changes on a logarithmic scale (a mathematical scale where each whole number step represents a tenfold change), so the figures reflect meaningful shifts in virus-related measurements, but this summary does not draw any conclusions about what those changes mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04449029 · results posted 16 May 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04449029) enrolled 457 adults with chronic hepatitis B — a long-term liver infection. Participants were split into eight groups based on two things: whether they were already taking a standard antiviral medicine called nucleoside/nucleotide analogue (NA) therapy, and which dosing schedule of the investigational drug GSK3228836 (also known as bepirovirsen) they received — either 24 weeks of the study drug, two different 12-week schedules, or starting with placebo for 12 weeks then switching to the study drug. The trial's main goal was to measure how many people achieved a "sustained virologic response" — meaning that two specific hepatitis B markers in the blood (called HBsAg, a surface protein, and HBV DNA, the virus's genetic material) both dropped below a detectable level by the end of treatment and stayed that way for 24 weeks afterwards, without needing rescue medication. The reported data shows that for the primary outcome, the numbers achieving this sustained response were relatively small across all groups. Among those already on NA therapy, the numbers were: 6 out of 68 (24-week group), 6 out of 68 (12+12-week group), 2 out of 68 (12 weeks active then 12 weeks placebo), and 0 out of 23 (placebo first then active). Among those not on NA therapy: 7 out of 70, 4 out of 68, 1 out of 68, and 0 out of 24, respectively. For a secondary measure — having both markers below the detectable level just at the end of treatment (before the 24-week follow-up) — the reported numbers were higher, ranging from 1 to 17 participants per group. For ALT normalisation (a liver enzyme returning to a normal range), the reported data shows varying numbers across groups, with the not-on-NA-therapy groups generally reporting more participants achieving this. The median time for ALT to normalise ranged from 1 week to about 18 weeks depending on the group, though these figures apply only to participants whose ALT was above the normal range at the start. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04454567 · results posted 20 October 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04454567) enrolled just two people — one person received a combination of the investigational drug ABI-H0731 plus a standard antiviral treatment (referred to as SOC NrtI), and one person received a placebo plus the same standard antiviral treatment. The trial was set up to measure things like unwanted health events (adverse events), unexpected changes in lab test results, early stopping of treatment, and whether a hepatitis B virus measurement in the blood (called HBV DNA) fell below a detectable threshold by Week 48. Neither participant completed the study. The reported data shows that when it came to adverse events (unexpected health occurrences recorded during the trial), none were reported in the ABI-H0731 group, while one was reported in the placebo group. Both participants — one from each group — stopped their treatment early, and both had at least one unusual lab test result recorded. For the main measure of whether HBV DNA levels dropped below the detectable threshold by Week 48, no data was reported for either group. Similarly, the two secondary outcome measures — which looked at changes in HBV DNA levels over time and at various individual time points — also had no data reported. It is worth noting that because only two people took part in total and neither completed the study, the reported numbers are extremely limited. The reported data shows only what was recorded for these two individuals and cannot be used to draw any broader conclusions about the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04465916 · results posted 12 October 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04465916) enrolled 26 people in total — 19 in the experimental arm (receiving vonafexor on top of their existing hepatitis B treatment) and 7 in the control arm (receiving their existing treatment alone). All 19 people in the experimental arm completed the study, while 6 out of 7 in the control arm completed it. The trial was primarily measuring changes in a protein called HBsAg (hepatitis B surface antigen — a marker found in the blood of people with hepatitis B infection), looking at how much its level changed over 16 weeks of treatment. The change was measured on a logarithmic scale, which is a way of expressing large ranges of numbers more compactly. The reported data shows that the average change in HBsAg levels from the start to week 16 was −0.029 log10 IU/mL in the experimental arm and −0.066 log10 IU/mL in the control arm. In plain terms, both groups showed a very small decrease in this blood marker over the 16-week period, with the control arm showing a slightly larger decrease than the experimental arm. The reported data also shows results for a secondary measure called "virologic failure" — meaning a meaningful rise in the amount of hepatitis B virus detected in the blood. According to the results reported on ClinicalTrials.gov, zero participants in either group experienced virologic failure at any of the four time points measured (week 16, and then at weeks 20, 28, and 40 during a follow-up period). It is worth noting that this was a small trial with 26 participants in total, and the results as submitted reflect only what was observed in this specific group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04398134 · results posted 26 August 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called ABI-H2158 combined with an existing hepatitis B medicine called entecavir (ETV), compared with a placebo (inactive treatment) plus entecavir, in people living with chronic hepatitis B. Participants were divided into two groups based on a marker of the virus called HBeAg — those who tested positive for it and those who tested negative. In total, 88 people started the trial: 32 in the HBeAg-positive group receiving ABI-H2158 plus entecavir, 11 in the HBeAg-positive placebo group, 33 in the HBeAg-negative group receiving ABI-H2158 plus entecavir, and 12 in the HBeAg-negative placebo group. The reported data shows that none of the participants completed the trial as planned — all 88 were recorded as not completing it, though the data does not explain why. The reported data shows the trial measured several things. For unwanted events (called adverse events) experienced while on treatment, 18 out of 32 participants in the HBeAg-positive ABI-H2158 group, 6 out of 11 in the HBeAg-positive placebo group, 19 out of 33 in the HBeAg-negative ABI-H2158 group, and 6 out of 12 in the HBeAg-negative placebo group reported at least one such event. Regarding abnormal laboratory test results, 29 out of 32, 8 out of 11, 19 out of 33, and 9 out of 12 participants respectively showed at least one abnormal result during the study. Two participants in each of the ABI-H2158 groups (HBeAg-positive and HBeAg-negative) stopped taking the study treatment early, while none in the placebo groups did. For one measure — the change in the amount of hepatitis B virus detected in the blood (measured on a scientific scale called log10) — the reported data shows a change of −6.2 in the HBeAg-positive ABI-H2158 group and −4.8 in the HBeAg-positive placebo group; figures for the HBeAg-negative groups were not reported. For the two secondary measures related to drug levels in the blood, no data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03434353 · results posted 4 April 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03434353) enrolled 123 people across five groups to study a drug called inarigivir soproxil in people with hepatitis B. Four of the groups received inarigivir soproxil at different doses (50 mg, 100 mg, 200 mg, or 400 mg) combined with another antiviral medication, while one group received an antiviral medication alone as a comparison. The trial was mainly measuring changes in a hepatitis B surface protein (called HBsAg) in participants' blood — a marker used to track the virus — after 12 weeks of treatment. Not all participants who started the trial finished it: completion numbers ranged from 9 out of 12 in one group to 12 out of 30 in another. The reported data shows that for the main outcome — the proportion of participants whose HBsAg level dropped by a meaningful amount (at least 0.5 log, meaning roughly a third or more reduction) by week 12 — the figures were: 23.3% in the 50 mg inarigivir + antiviral group, 25.0% in the antiviral-only comparison group, 0% in the 200 mg inarigivir + antiviral group, 6.7% in the 400 mg inarigivir + antiviral group, and 0% in the 100 mg inarigivir + other antiviral group. For a larger drop (at least 1 log, roughly a tenfold reduction), the reported data shows 0% across all inarigivir groups, while 16.7% was recorded in the antiviral-only comparison group. For participants who carried a specific hepatitis B marker called HBeAg, the data shows that between 0% and 14.3% across the groups lost that marker or showed a change in related antibodies over the course of the trial, depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03685708 · results posted 15 December 2021

  According to the results reported on ClinicalTrials.gov, this trial looked at how well a hepatitis B vaccine called HEPLISAV-B produced a protective level of immunity in people with a blood cancer called chronic lymphocytic leukaemia (CLL). A total of 78 people started the study across three groups: 14 were receiving a treatment called acalabrutinib, 18 were receiving a treatment called ibrutinib (both are a type of targeted cancer medicine), and 46 had not yet started any CLL treatment. The vaccine was given in two doses over six months, and the main thing being measured was how many participants reached a blood antibody level considered protective against hepatitis B. The reported data shows that, of those who reached the end of the study, very few participants across all three groups achieved that protective antibody level. Specifically, none of the 14 participants in the acalabrutinib group reached the target level, 1 out of 18 in the ibrutinib group did, and 9 out of 46 in the untreated group did. For the secondary measurements, the trial also tracked serious unwanted health events after vaccination — the reported data shows that none occurred in the acalabrutinib or ibrutinib groups, and 1 was recorded in the untreated group. The trial also tracked whether anyone had to leave the study because they could not tolerate the vaccine; according to the reported data, no participants left for this reason in any of the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03672188 · results posted 13 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03672188) tested a drug called VIR-2218 across three parts (A, B, and C). Part A gave participants a single dose of VIR-2218 (at doses ranging from 50 mg to 900 mg) or a placebo. Parts B and C gave participants multiple doses over time (ranging from 20 mg to 200 mg) or a placebo. In total, 86 people started the trial across all groups. The trial was primarily measuring how many participants experienced adverse events (unexpected health changes or symptoms) and whether there were any notable abnormalities in things like blood tests, heart tracings (ECGs), or vital signs. The reported data shows that, among those who received VIR-2218 in the single-dose part (Part A), the number of participants who experienced at least one adverse event ranged from 3 to 5 per dosing group (out of 6–8 people in each group), while 6 out of 12 placebo participants also reported an adverse event. In the multiple-dose parts (B and C), the reported numbers ranged from 0 to 5 participants per group experiencing an adverse event. For clinically significant abnormalities in tests or measurements, the reported data shows that 1 participant per group in Part A (across both VIR-2218 and placebo groups) had a notable finding, while in Parts B and C, no participants were reported to have such abnormalities. Note that results for some groups in Parts B and C were not reported in the submitted data. The reported data also includes measurements of how the drug behaved in the bloodstream (sometimes called pharmacokinetics). For example, the highest level of VIR-2218 detected in the blood (peak concentration) ranged from 155 ng/mL at the lowest single dose to 5,010 ng/mL at the highest single dose, with lower peak levels seen in the multiple-dose groups. The time it took to reach that peak level ranged roughly from about 2.5 to 7.6 hours depending on the group. How long the drug took to clear from the blood (half-life — the time for the amount in the body to halve) ranged from around 2.5 to 5.3 hours across the single-dose groups; this figure was not reported for the multiple-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03410953 · results posted 8 July 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 67 adults who received a hepatitis B vaccine called Fendrix. All 67 participants completed the study — none dropped out. The trial was measuring how many people developed what researchers considered a "protective level" of antibodies (proteins the immune system makes in response to a vaccine) after receiving the treatment. The reported data shows that the primary outcome — the number of participants who reached the targeted antibody level — was measured at multiple points: after each dose of the vaccine. The results show that 63 out of 67 participants reached the targeted antibody level, while 4 participants did not. No further breakdown of timing or dosing details was included in the submitted results data, and no secondary outcome measure data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03577171 · results posted 28 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03577171) enrolled 25 people with hepatitis B. Thirteen participants received the investigational drug ABI-H0731 together with a standard antiviral medicine called entecavir (referred to as SOC ETV), while twelve received a placebo (inactive dummy) alongside the same standard antiviral. All 25 participants completed the study. The trial was primarily measuring changes in the amount of hepatitis B virus (HBV) genetic material — called HBV DNA — in participants' blood over 12 and 24 weeks. HBV DNA levels were measured on a logarithmic scale (log10), which is a mathematical way of expressing very large or very small numbers more manageably. The reported data shows that at the start of the study (Day 1), average HBV DNA levels were similar in both groups — around 7.91 log10 IU/mL in the ABI-H0731 group and 8.03 log10 IU/mL in the placebo group. By Week 12, the reported average reduction from baseline was −4.45 log10 IU/mL in the ABI-H0731 group compared with −3.30 log10 IU/mL in the placebo group. By Week 24, the reported reductions were −5.33 log10 IU/mL and −4.20 log10 IU/mL respectively. Regarding other monitored measures, the reported data shows that 7 out of 13 participants in the ABI-H0731 group and 5 out of 12 in the placebo group experienced one or more adverse events (unwanted health occurrences during the trial). Abnormal laboratory test results were recorded in 8 participants in the ABI-H0731 group and 10 in the placebo group. No participants in either group had a clinically significant heart tracing (ECG) abnormality or a clinically significant change in vital signs such as temperature, breathing rate, or pulse, and no one left the study early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03038113 · results posted 24 December 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03038113) tested an investigational drug called RO7062931 in a total of 119 participants across two main parts. Part 1 tested single doses ranging from 0.1 mg/kg to 4.0 mg/kg (with 8 people per active dose group and 12 receiving a placebo). Part 2 tested multiple doses given at different frequencies — either once a month, once a week, or once every two weeks — with group sizes ranging from 4 to 15 people. The trial was primarily measuring how often participants experienced adverse events (unexpected or unwanted medical occurrences) and notable changes in laboratory blood tests and heart trace (ECG) readings. It also tracked how much of the drug appeared in participants' blood. The reported data shows that the percentage of participants who experienced adverse events varied across groups. In Part 1, this ranged from 37.5% in the 1.0 mg/kg group up to 87.5% in the 0.3 mg/kg and 3.0 mg/kg groups, while 58.3% of the Part 1 placebo group reported adverse events. In Part 2, the figures ranged from 33.3% to 85.7% across active dose groups, though results for some groups were not reported in the submitted data. For laboratory abnormalities, most groups showed 0%, with the exception of the 1.0 mg/kg single-dose group (12.5%) in Part 1, and the 3.0 mg/kg weekly group in Part 2 (14.3%). For heart trace (ECG) readings in Part 1, the percentage of participants with recorded abnormalities ranged from 0% to 50% depending on the dose group, and 16.7% in the placebo group. Regarding blood levels of the drug, the peak concentration measured after a single dose rose with increasing dose — from 7.78 nmol/L at the lowest dose to 312.53 nmol/L at the highest. In the multiple-dose part of the trial, peak blood concentrations also generally increased with higher doses and more frequent dosing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02981602 · results posted 21 December 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02981602) tested a drug called GSK3228836 (also known as bepirovirsen) in people with hepatitis B. A total of 31 participants took part across five groups: 6 people received a 150 mg dose, 12 received a 300 mg dose (across two combined groups), 5 received a 300 mg dose in a separate fourth group, and 8 received a placebo (an inactive treatment used for comparison). The trial was primarily measuring safety-related markers — including unwanted health events that occurred during the study, and changes in blood test results covering liver enzymes, kidney markers, blood cell counts, and other chemical measures in the blood. The reported data shows that when it came to unwanted health events (called adverse events), 5 out of 6 participants in the 150 mg group and 6 out of 12 in the 300 mg combined group experienced them, compared with 2 out of 6 in the matching placebo group and 3 out of 5 in the separate fourth-group 300 mg arm. Serious adverse events (those considered most significant, such as requiring hospitalisation) were reported in none of the 150 mg group, 1 of the 300 mg combined group, none of the placebo groups, and none of the fourth-group 300 mg arm. For the blood test results, the reported data shows various small rises and falls in liver enzyme levels, blood chemistry values, and blood cell counts across all groups. For example, changes in one liver enzyme (ALT) ranged from a decrease of 0.7 units per litre in the placebo group to an increase of 52.5 units per litre in the 300 mg combined group. Many other individual blood markers showed only small numerical changes, and where data was not fully reported for all groups and time points, those figures were not available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02421666 · results posted 8 October 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 532 adults living with chronic hepatitis B (a long-term liver virus infection) — 272 people in a group that received a behavioural support program called PNMI, and 260 people who received usual care. The trial was measuring whether people kept up with the recommended monitoring for their condition: specifically, whether they visited a doctor for their hepatitis B and whether they had a blood test (checking a liver marker called ALT) at least every six months. Results were recorded at six months and again at twelve months. The reported data shows the following counts of participants who were recorded as keeping up with their monitoring at each check-in point. In the PNMI group, 200 out of 272 participants met the doctor-visit measure at six months, compared with 113 out of 260 in the usual-care group. At twelve months, those numbers were 225 (PNMI) versus 140 (usual care). For the blood-test measure, 137 participants in the PNMI group and 62 in the usual-care group met that measure at six months; at twelve months, the figures were 164 (PNMI) and 87 (usual care). No other outcome data beyond these participant counts was included in the submitted results. It is worth noting that some participants did not complete all follow-up stages — by the twelve-month point, 248 of the original 272 PNMI participants and 231 of the original 260 usual-care participants remained in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02263079 · results posted 24 August 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were divided into three groups: 26 people received a combination of pegylated interferon alfa-2a (an immune-boosting injection) plus one of two antiviral tablets (lamivudine or entecavir); 33 people were observed without any treatment; and 3 people received interferon alone. The trial's main goal was to measure how many participants lost a specific protein on the surface of the hepatitis B virus — called hepatitis B surface antigen, or HBsAg — at 24 weeks after finishing treatment or observation, as losing this marker is considered a notable milestone in managing the infection. The reported data shows that, for the primary goal of HBsAg loss at 24 weeks after treatment or observation, 3.8% of participants in the treated combination group achieved this (roughly 1 in 26), while 0% of the untreated group did. For several of the secondary measurements — including loss of another viral protein (HBeAg), development of protective antibodies, and virus levels in the blood falling below certain thresholds — the percentages reported across the treated and untreated groups generally ranged from 0% to around 15%, with some variation depending on the specific measure and time point. The small number of participants in the interferon-only group (3 people) means no separate percentage figures were reported for that group across most outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03393754 · results posted 7 July 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,607 adults aged 18 and over who received one of two hepatitis B vaccines — Engerix-B® (811 people) or Sci-B-Vac® (796 people). The trial was measuring how many participants developed a level of hepatitis B antibodies in their blood considered high enough to indicate protection (at least 10 mIU/mL), assessed about four weeks after completing a three-dose course. This was looked at for all adults aged 18 and over, and separately for the older group aged 45 and over. The reported data shows that, among all adults aged 18 and over, 76.49% of those in the Engerix-B® group and 91.36% of those in the Sci-B-Vac® group reached that antibody level by day 196 of the study. In the older group (aged 45 and over), the reported figures were 73.05% for Engerix-B® and 89.44% for Sci-B-Vac®. The trial also recorded the number of participants who reported certain expected side effects in the seven days after any vaccination — for example, local reactions (such as at the injection site) were reported by 294 people in the Engerix-B® group and 503 in the Sci-B-Vac® group, with various other tracked reactions also recorded across both groups. The full breakdown of all reported side-effect categories was not individually labelled in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02579382 · results posted 18 May 2020

  According to the results reported on ClinicalTrials.gov, this trial looked at the combination of a hepatitis B medicine called TDF (tenofovir disoproxil fumarate) with different doses of a second drug called vesatolimod, compared to TDF on its own (with a dummy/placebo pill). A total of 192 people took part in the main phase of the trial, split across four groups: 28 received TDF plus placebo, 53 received TDF plus vesatolimod 1 mg, 56 received TDF plus vesatolimod 2 mg, and 55 received TDF plus vesatolimod 4 mg. The trial's main focus was measuring changes in a protein found on the surface of the hepatitis B virus (called HBsAg) in the blood over 24 weeks — with lower levels generally considered a marker of interest in hepatitis B research. The reported data shows that after 24 weeks, all four groups had small reductions in HBsAg levels. To understand the numbers: these changes are measured on a "log10" scale, meaning even small numbers represent meaningful shifts. The placebo group showed a change of −0.163, the 1 mg vesatolimod group showed −0.056, the 2 mg group showed −0.146, and the 4 mg group showed −0.036. Similar small changes were also reported at the 12-week point across all groups. In terms of secondary outcomes — including whether participants' blood went from testing positive to negative for certain hepatitis B markers (called HBsAg loss and HBeAg loss) — the reported data shows that at week 24, none of the participants in any group achieved this change. By week 48, zero percent in all groups had lost the HBsAg marker, while a small percentage showed HBeAg loss and seroconversion (a related marker change): 0% in the placebo group, 5.0% in the 1 mg group, 4.3% in the 2 mg group, and 4.8% in the 4 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03180619 · results posted 9 April 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03180619) enrolled 124 people in total across three groups: 78 people with moderate or severe kidney (renal) impairment, 15 people with end-stage kidney disease, and 31 people with liver (hepatic) impairment. The trial was measuring how well a study drug reduced the amount of hepatitis B virus (HBV) in participants' blood, as well as tracking unwanted health events (called adverse events) and unusual blood test results that occurred during treatment. The reported data shows that, at the 24-week mark, 97.4% of participants in the moderate/severe kidney impairment group, and 100% of participants in both the end-stage kidney disease group and the liver impairment group, had HBV levels in their blood fall below the target threshold of 20 IU/mL (a very low, hard-to-detect level). Regarding adverse events — that is, any health problems that arose during the study — the reported data shows that by week 24, roughly 54–73% of participants across the three groups experienced at least one graded adverse event, with around 6–13% experiencing a more severe graded event. Laboratory (blood test) abnormalities that worsened from the start of the study were reported in 90–100% of participants across the groups by week 24, with higher-severity abnormalities reported in 12–49% of participants. By weeks 48 and 96, the proportions reporting adverse events and laboratory abnormalities remained broadly similar or increased somewhat across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02457637 · results posted 22 January 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,600 adults who had been admitted to hospital with a condition called acute-on-chronic liver disease — meaning they had an existing long-term liver condition that had suddenly worsened. The trial tracked what happened to these patients over time, looking at how many died, how many received a liver transplant, and how many died without receiving a transplant. Participants were followed up for periods of 28 days, 90 days, and 180 days. The reported data shows that within the first 28 days, 74 participants died without receiving a liver transplant, and 124 participants received a liver transplant. By 90 days, the number who died without a transplant had risen to 333, and 171 participants had received a transplant during that period. By 180 days, 403 participants had died without receiving a transplant, and 177 had received one. The reported data also shows that 261 participants experienced at least one organ (such as the kidneys, brain, or lungs) stopping working properly at some point during their hospital stay. A blood measurement related to liver function (called bilirubin — a substance that builds up when the liver is struggling) was reported at an average of 9.3 mg/dL at the end of the 28-day period. Some other planned measurements, including detailed disease severity scores over time, were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02853929 · results posted 14 January 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02853929) enrolled 270 people in the dTpa vaccine group and 281 people in a control group, with 259 and 277 respectively completing the study. The trial was measuring two main things: first, how many participants had antibody levels (proteins the body makes in response to a vaccine) that reached a threshold linked to protection against diphtheria, tetanus, hepatitis B, three types of poliovirus, and a bacteria called Hib; and second, how many showed a meaningful rise in antibodies against three whooping cough (pertussis) components after vaccination. The reported data shows that, for the first primary measure — reaching protective antibody thresholds — the numbers varied by disease. For example, for diphtheria and tetanus, 221 participants in the dTpa group and 247 in the control group met the threshold. For hepatitis B, the figures were 215 (dTpa) and 239 (control). For the three poliovirus types the numbers ranged from 188 to 204 (dTpa) and 210 to 228 (control). For the whooping cough booster response measure, results also varied across the three pertussis components — for example, one component (PT) showed 62 in the dTpa group and 40 in the control group meeting the booster response definition, while another (FHA) showed 98 versus 124. The reported data also includes several secondary measures, such as antibody levels (reported as average concentrations) for diphtheria, tetanus, and the whooping cough components, as well as antibody counts for pneumococcal bacteria strains. For instance, average diphtheria antibody concentrations were reported as 0.207 units/mL in the dTpa group and 0.322 units/mL in the control group, while average tetanus concentrations were 6.114 and 8.402 units/mL respectively. Some of the secondary outcome data — such as full breakdowns for all pneumococcal strains — were reported for both groups but figures for certain individual sub-measures within outcomes were not always accompanied by further detail beyond participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03258710 · results posted 2 January 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 75 participants, all of whom received a medicine called Tenofovir Disoproxil Fumarate for chronic hepatitis B (a liver infection caused by the hepatitis B virus). Of the 75 who started, 72 completed the study and 3 did not. The trial was measuring changes in certain proteins in the blood that are associated with the hepatitis B virus — specifically a surface protein called HBsAg and an envelope protein called HBeAg — at various points over roughly two years (weeks 24, 48, and 96). The reported data shows that for the main (primary) outcome — whether a participant's HBsAg level fell by a meaningful amount (0.25 log10 units, meaning roughly a 44% drop) by week 48 — 4% of participants met that threshold, while 96% did not. For a similar measurement taken earlier (week 24), only 1% met the threshold, and by week 96 that figure was 12%. The reported data shows that no participants (0%) lost HBsAg entirely or developed a protective antibody response to HBsAg at any of the three time points measured. Regarding the HBeAg protein, the proportion of participants who lost that marker was reported as 12% at both weeks 24 and 48, rising to 25% at week 96. The proportion who went on to develop an antibody response to HBeAg (known as seroconversion) was reported as 8% at week 24, 13% at week 48, and 25% at week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02203357 · results posted 3 October 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at how the body responds to a hepatitis B vaccine when given at different doses and on different timing schedules. A total of 353 healthy young adults took part across three groups: 117 received a lower dose (20 micrograms) on a three-shot schedule spread over six months; 111 received a higher dose (60 micrograms) on a two-shot schedule over one month; and 125 received the same higher dose on a two-shot schedule spread over two months. The trial tracked antibody levels — proteins the body makes in response to the vaccine — over a period of up to two years. The reported data shows antibody levels were measured in units called mIU/ml at several points in time. The trial considered a level of 10 mIU/ml or above as a "protective" threshold, with levels above 1,000 mIU/ml described as a "high" response. At the earliest measurement point, the reported average antibody levels (called geometric mean concentrations, which is a way of averaging numbers that can vary widely) were approximately 1,848 mIU/ml for the lower-dose three-shot group, 839 mIU/ml for the higher-dose one-month group, and 1,245 mIU/ml for the higher-dose two-month group. At a later time point, the reported figures were around 1,457 mIU/ml, 256 mIU/ml, and 235 mIU/ml respectively. By the final measurement at around two years, the reported levels had changed to approximately 427 mIU/ml, 90 mIU/ml, and 90 mIU/ml across the three groups. Regarding monitored reactions after vaccination, the reported data shows that 2 participants in each of the first two groups and 5 participants in the third group experienced adverse events that were recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02979613 · results posted 25 September 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 245 participants in each of two groups — one group took a medicine called TAF (25 mg) and the other took a medicine called TDF (300 mg), giving a total of 490 people. The trial was studying treatments for chronic hepatitis B, a liver infection caused by the hepatitis B virus. The main thing being measured was the amount of hepatitis B virus in participants' blood (called "HBV DNA") — specifically, how many people still had a detectable level of virus (at or above 20 IU/mL, a standard cut-off used in hepatitis B research) after 48 weeks. The trial had two phases: a double-blind phase (where neither participants nor researchers knew who was taking which medicine) lasting 48 weeks, followed by an open-label extension phase out to 96 weeks (where both parties knew which medicine was being taken). The reported data shows that at the 48-week mark, 0.4% of participants in both the TAF group and the TDF group still had virus levels at or above that cut-off — meaning the vast majority had virus levels below it. Specifically, 96.3% of participants in both groups were reported to have virus levels below the 20 IU/mL threshold at week 48. At 96 weeks, the reported data shows similar figures: 94.7% of the TAF group and 93.9% of the TDF group had virus levels below that threshold, and again only 0.4% in each group were above it based on the snapshot measurement approach used. Additional measurements were also taken using a stricter detection method (looking for whether the virus was detectable at all, even at very low levels); using that stricter approach, around 63–66% of participants across both groups and both timepoints had completely undetectable virus levels, depending on how missing data were handled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02964910 · results posted 25 July 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 235 people with chronic hepatitis B and 240 healthy volunteers, for a total of 475 participants. The trial was measuring how the body responded to a hepatitis E vaccine — specifically, whether people developed detectable antibodies (proteins the immune system makes in response to a vaccine) after receiving three doses of the vaccine. It also tracked liver function readings and any unwanted reactions during the study period. The reported data shows that for the main (primary) outcome — whether participants developed detectable hepatitis E antibodies one month after their third dose — 188 out of the chronic hepatitis B group and 196 out of the healthy volunteer group did so. A separate measurement looked at the *level* of those antibodies (expressed in WHO units per millilitre, a standardised way of measuring antibody amounts): the chronic hepatitis B group recorded an average level of 11.89 Wu/ml, compared with 17.35 Wu/ml in the healthy volunteer group. Regarding liver function, which was tracked using three standard blood markers (ALT, AST, and TBIL) at several time points, the reported data shows that the large majority of participants in both groups showed no change in their liver function grade across the observation period, with smaller numbers recorded as having either a worsening or an improvement in those readings. For unwanted reactions or events across the whole study period, 92 participants in the chronic hepatitis B group and 97 in the healthy volunteer group were reported to have experienced at least one adverse reaction or event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02858440 · results posted 19 July 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02858440) involved 235 children who received a combination vaccine called DTPa-IPV/Hib, which protects against diphtheria, tetanus, whooping cough (pertussis), polio, and a bacteria called Haemophilus influenzae type b (Hib). A total of 223 children completed the study. The trial was measuring how many children developed detectable levels of antibodies — the body's immune proteins — against each of these diseases after their primary course of vaccinations and again after a booster dose. The reported data shows that after the primary vaccination course, 176 out of the children tested had antibody levels above a set threshold for both diphtheria and tetanus. For polio, the numbers reaching the threshold were 151 (type 1), 151 (type 2), and 150 (type 3). For Hib, 179 children reached the antibody threshold. For whooping cough components, the numbers were 175 (for two components called PT and FHA) and 174 (for a third component called pertactin). After the booster dose, the reported data shows 188 children reached the antibody threshold for both diphtheria and tetanus, and for polio the figures were 176 (type 1), 169 (type 2), and 167 (type 3). No booster data for the whooping cough or Hib components was reported in the submitted results. It is worth noting that the total number of children included in each individual measurement was not always clearly stated in the submitted data, so the figures above reflect the counts as provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02065336 · results posted 5 July 2019

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational treatment called ARC-520 in people with hepatitis B (a viral liver infection). Participants were divided into groups — most receiving different doses of ARC-520, and one group receiving a placebo (a dummy treatment with no active ingredient, normal saline). In the main study phase, a total of 64 people participated across seven ARC-520 groups and one placebo group, and all of them completed that phase. A further 10 people took part in a separate extension phase across two additional cohorts, though none of those participants completed it. The trial's main focus was on measuring changes in a protein called hepatitis B surface antigen (HBsAg), which is a marker found in the blood of people with hepatitis B. The reported data shows that across the ARC-520 groups in the main study, the measured levels of HBsAg generally went down from where they started (baseline). The reductions reported varied quite a bit between groups — for example, one group (Cohort 1) showed an average change of around −555 IU/mL, while another (Cohort 7) showed a much larger average change of around −12,401 IU/mL. In contrast, the placebo group showed an average change of +43.3 IU/mL, meaning levels in that group were slightly higher at follow-up than at the start. For the extension phase group (Cohort 10), the reported average change was −19,222 IU/mL, though it is worth noting those participants did not complete the extension phase. The reported data also shows that the number of participants who experienced adverse events (unwanted medical occurrences during the trial) varied across groups — ranging from 0 to 7 participants per group. All participants in the allergy testing component returned negative results for bee venom allergy at each time point tested, which was used as a safety screening measure for this particular type of treatment. Some pharmacokinetic measurements (tracking how the drug moves through the body over time) were also reported, but these are technical figures relating to drug levels in the blood rather than health outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02759354 · results posted 27 June 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 754 infants across four groups. Two groups received a vaccine called Vaxelis and two groups received a vaccine called Infanrix Hexa. The groups were also split by dosing schedule — either a "3+1" schedule (three early doses plus a booster) or a "2+1" schedule (two early doses plus a booster). All 754 participants who started the trial were recorded as completing it. The trial was measuring how many infants developed detectable antibodies — the body's immune response proteins — to several components of the vaccines, including Hepatitis B and whooping cough (pertussis). The reported data shows that for the Hepatitis B component, the percentage of participants whose antibody levels reached the response threshold was 70.2% in the Vaxelis 3+1 group, 82.0% in the Infanrix Hexa 3+1 group, 65.8% in the Vaxelis 2+1 group, and 83.7% in the Infanrix Hexa 2+1 group. A separate measure — the average antibody concentration level (a way of expressing the typical amount of antibodies across the group) — was 24.4 units/mL for Vaxelis 3+1, 51.3 for Infanrix Hexa 3+1, 19.4 for Vaxelis 2+1, and 71.0 for Infanrix Hexa 2+1. For the whooping cough (pertussis) components, which were only measured in the 2+1 schedule groups, the reported data shows varying response percentages across three different pertussis proteins — pertussis toxin, filamentous hemagglutinin, and pertactin — with figures ranging roughly from around 14% up to about 88% depending on the protein and the vaccine group. The average antibody concentration for pertussis toxin was reported as 5.3 units/mL for Vaxelis 2+1 and 3.6 units/mL for Infanrix Hexa 2+1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02422264 · results posted 10 June 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02422264) enrolled 601 participants in total — 296 in the dTpa vaccine group and 305 in a control group. The study was measuring how the body responded to a booster vaccine against whooping cough, diphtheria, and tetanus (the dTpa vaccine), given alongside other routine vaccines including hepatitis B, polio, and Haemophilus influenzae type b (Hib). The trial tracked whether participants developed or maintained a detectable level of antibodies (proteins the immune system produces) against each of these diseases after vaccination. The reported data shows the following numbers of participants who met the defined response or protection thresholds after vaccination. For whooping cough components, 185 out of the dTpa group versus 249 in the control group met the response definition for one component (PT); 95 versus 238 for a second component (FHA); and 90 versus 225 for a third (PRN). For diphtheria protection, 264 (dTpa) versus 271 (control) met the threshold, and for tetanus, 266 versus 271. For hepatitis B, 251 versus 259 participants met the protection threshold. For the three polio virus types, the numbers were 233 vs 242, 239 vs 235, and 228 vs 236. For Hib (the PRP antigen), 255 versus 256 participants met the threshold. Secondary outcome data for pre-vaccination diphtheria and tetanus protection showed 200 versus 110 for diphtheria, and 240 versus 225 for tetanus. The reported data shows participant numbers only — information on what these figures mean in terms of proportions or statistical comparisons was not included in the structured data submitted to ClinicalTrials.gov for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02577029 · results posted 12 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people across eight groups (called cohorts), with between 2 and 13 participants in each group. The trial was studying an investigational injection called ARC-520 in people with chronic hepatitis B (a long-term liver infection). The main thing researchers were trying to measure was whether participants' blood levels of a hepatitis B protein — called hepatitis B surface antigen, or HBsAg — dropped by a meaningful amount (specifically, a "1-log reduction," meaning a tenfold decrease) by week 60 of the study, after 48 weeks of receiving the treatment. The reported data shows that no results were submitted for the primary outcome measure — that is, the figures for how many participants achieved that tenfold reduction in the hepatitis B protein were not reported on ClinicalTrials.gov. Several secondary (additional) outcomes were also left without reported numbers, including data on HBsAg loss over time, time to losing the surface antigen, levels dropping below a certain threshold, and whether the body developed a protective antibody response. The one secondary outcome that did include numbers related to adverse events (unwanted health changes that occurred after dosing that were considered possibly or probably linked to the treatment). The reported data shows that across the eight cohorts, the number of participants in this category ranged from 0 to 4 per group. A smaller set of figures also appears to relate to serious adverse events, with zeros reported for the groups where data was provided — however, the data as submitted is not fully labelled, so a complete group-by-group breakdown cannot be confirmed. It is worth noting that the data shows zero participants were recorded as having "completed" the study in any of the eight cohorts, though what this specifically means in the context of this trial's design was not explained in the submitted results. Many of the planned outcome measures were not accompanied by any numbers at all, meaning a full picture of what the trial found is not available from the information submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01341639 · results posted 10 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 628 infants in the PR5I vaccine group and 622 in the INFANRIX™ Hexa comparison group. The trial was measuring how the body responded — specifically, whether detectable levels of antibodies (proteins the immune system produces) were present in the blood after vaccination — to a range of diseases covered by these childhood vaccines. These included diphtheria, tetanus, whooping cough (pertussis), hepatitis B, polio, and Haemophilus influenzae type b (Hib), as well as measles, mumps, rubella, and chickenpox (varicella) following a later booster dose. Blood tests were taken at around 5 months of age (after the infant course) and again at around 13 months of age (after a toddler booster dose). The reported data shows that, after the infant vaccination course, between approximately 98% and 100% of participants in the PR5I group had antibody levels above the pre-set thresholds for Hib, diphtheria, tetanus, and all three polio types. For the INFANRIX™ Hexa comparison group, the reported figures ranged from approximately 87% to 100% across the same disease targets — with the Hib result notably lower at around 87% compared to around 98% in the PR5I group. After the toddler booster dose at 13 months, the reported data shows that between approximately 95% and 100% of PR5I participants had antibody levels above the relevant thresholds across all measured disease targets, including hepatitis B and whooping cough components. Results for INFANRIX™ Hexa participants at 13 months were broadly similar, ranging from approximately 99% to 100% for hepatitis B and whooping cough-related measures. For the measles, mumps, rubella, and varicella (chickenpox) vaccine given alongside both groups at the toddler stage, the reported antibody response rates were between approximately 95% and 98% in the PR5I group and approximately 92% to 97% in the INFANRIX™ Hexa group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01480258 · results posted 2 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 656 infants in the PR5I group and 659 infants in the INFANRIX™ Hexa group, with the large majority completing all stages of the study. The trial was comparing two combination childhood vaccines — PR5I and INFANRIX™ Hexa — both of which protect against multiple diseases including diphtheria, tetanus, whooping cough (pertussis), polio, hepatitis B, and a bacterial infection called Haemophilus influenzae type b (Hib). The main thing being measured was the proportion of children who showed an antibody response (a sign the immune system had recognised the vaccine) to each of the diseases covered by PR5I, one month after a toddler booster dose given at around 11–12 months of age. The reported data shows that, for the primary measurement in the PR5I group one month after the toddler dose, the percentages of children who met the pre-set antibody response targets ranged from approximately 89.9% to 99.8% depending on which disease component was being measured. For one of the secondary measurements — the antibody response to Hib one month after the second infant dose (at around 4 months of age) — the reported figures were 72.9% of children in the PR5I group and 26.7% in the INFANRIX™ Hexa group reaching the target level. After the toddler dose, response rates for both groups across most antigens were broadly similar, generally ranging from around 89% to 100%. The reported data also shows that adverse events (unwanted effects tracked over the 15 days following each vaccination) were recorded in approximately 88–100% of participants across both groups at various time points, though the data does not break down the nature or severity of those events in the figures provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02862548 · results posted 26 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 26 in a group taking TAF 25 mg (a hepatitis B medication) and 25 in a group taking regimens containing TDF (another hepatitis B medication). The trial was measuring two main things at 24 weeks: changes in kidney filtering ability (using a standard calculation called eGFR, which estimates how well the kidneys are working) and the proportion of participants whose hepatitis B virus levels in the blood fell below a very low threshold of 20 IU/mL. It also tracked changes in bone density at the hip and spine at 24 and 48 weeks. The trial had two phases — the first up to 48 weeks, followed by a longer open-label extension phase out to around week 192 (roughly four years), where participants could continue in the study. The reported data shows that at week 24, kidney filtering scores increased slightly in both groups — by about 2.13 units in the TAF group and 1.87 units in the TDF group (measured in standard kidney function units). For hepatitis B virus levels, the reported data shows that 100% of participants in both groups had virus levels below the 20 IU/mL threshold at week 24. Regarding bone density, the reported data shows small increases at the hip for both groups at week 24 (roughly +0.48% for TAF and +0.45% for TDF), but by week 48 the TAF group showed a reported increase of about +1.25% while the TDF group showed a reported decrease of about -0.41%. At the spine, the TAF group showed reported increases at both 24 weeks (+0.80%) and 48 weeks (+1.45%), while the TDF group showed reported decreases at both time points (-0.19% at week 24 and -1.08% at week 48). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03619590 · results posted 4 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 103 participants, all of whom completed the study. It was a pregnancy registry — meaning it tracked women who had received the Twinrix vaccine (a combined hepatitis A and B vaccine) either just before or during their pregnancy. The study followed each participant until after their estimated delivery date and recorded what happened at the end of the pregnancy. The trial was not testing whether the vaccine worked; it was simply observing and recording pregnancy outcomes for women who had already received the vaccine. The reported data shows that pregnancy outcomes were grouped depending on when the vaccine was received — just before conception, or during the first, second, third, or an unspecified trimester of pregnancy. For each group, the study counted four types of outcomes: live births (with or without birth defects noted), miscarriages (called spontaneous abortions), terminations (induced abortions), and fetal deaths. The largest group was women exposed during the first trimester, where the reported data shows 63 live births (3 with birth defects noted, 60 without), 7 miscarriages, 0 induced abortions, and 5 fetal deaths. For those exposed just before conception, there were 5 live births (4 without birth defects, 1 with), 1 miscarriage, and 1 induced abortion. Smaller numbers were recorded for second trimester (13 live births, no other outcomes reported), third trimester (1 live birth), and unspecified timing (9 live births and 2 miscarriages). The reported data shows only the counts of these outcomes as they occurred in this particular group of participants; no comparison group (such as unvaccinated pregnant women) was included in this registry, so the numbers cannot be compared against a baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02798952 · results posted 1 February 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 302 participants, all in a single group called the "Engerix-B Kinder Group." All 302 participants completed the study with none dropping out. The trial was measuring levels of a specific antibody — called anti-HBs — that the body produces in response to the hepatitis B vaccine Engerix-B. Antibody levels were measured at different points in time, and participants were also given a follow-up "challenge" dose of the vaccine to see how their immune system responded. The reported data shows that after vaccination, the average antibody level (expressed as a geometric mean concentration, which is a way of calculating an average for values that vary widely) was 1,975.7 mIU/mL (milliunits per millilitre, a standard measurement unit for antibodies). A separate antibody measurement — reported as a secondary outcome and likely taken at a different time point — recorded a much lower average of 15.6 mIU/mL. For the seropositive count (meaning participants whose antibody levels were above the lowest detectable threshold of 6.2 mIU/mL), the reported figures were 163 participants at one time point and 255 at another. For seroprotection (antibody levels at or above 10 mIU/mL, a pre-defined threshold), the numbers were 144 and 250 participants at those respective time points. The number of participants with antibody levels above 100 mIU/mL was 45 at one point and 234 at another. Finally, 248 participants were reported to have shown an "anamnestic response" to the challenge dose — meaning their immune system appeared to respond to the extra dose according to pre-defined criteria. It is worth noting that the reported data does not clearly label which time points each measurement corresponds to, so the exact timing of some of these figures is not possible to confirm from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02540538 · results posted 29 November 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02540538) enrolled 34 people across three groups. Twelve participants had never been vaccinated against hepatitis B and received a standard hepatitis B vaccine called HBVaxPro; twelve more had also never been vaccinated but received an experimental vaccine called HBAI20; and ten were people who had previously been vaccinated against hepatitis B but had not developed a protective immune response, and who received HBAI20. The trial was measuring two main things: how many participants experienced reactions at the injection site or general body symptoms after vaccination, and how many developed a level of immune protection considered sufficient against hepatitis B (measured by a blood antibody test). The reported data shows that, when it came to any local or general reactions (of any level of severity) in the four days after the first injection, 8 out of 12 participants reported them in the HBVaxPro group, 9 out of 12 in the vaccine-naive HBAI20 group, and 7 out of 10 in the non-responder HBAI20 group. When looking only at severe reactions, the reported data shows that no participants in any group experienced a severe reaction after the first or second injection; after the third injection, 1 participant in the HBVaxPro group and 1 in the non-responder HBAI20 group reported a severe reaction, with none in the vaccine-naive HBAI20 group. For the secondary outcome — measuring how many people reached a protective level of immunity one month after their third vaccination — the reported data shows that 9 out of 12 participants in the HBVaxPro group, 10 out of 11 remaining participants in the vaccine-naive HBAI20 group, and 6 out of 10 in the non-responder HBAI20 group reached this level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01379508 · results posted 5 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 241 adults with a form of chronic hepatitis B (a liver infection). Participants were split into four groups based on which antiviral medicine they received — telbivudine (LdT) alone, tenofovir (TDF) alone, or a combination of both — and some were switched between treatments at week 24 based on how their virus levels were responding. The trial ran for up to about three years (156 weeks) and was primarily measuring what proportion of participants had their hepatitis B virus reduced to a very low level in the blood by week 52. The reported data shows that at week 52, approximately 91% of participants in the telbivudine group and approximately 95% of participants in the tenofovir group had virus levels fall below the target threshold. For secondary measurements taken later in the trial at week 156, the reported figures for virus suppression were lower across all groups, ranging from roughly 12% to 20% depending on the subgroup. Regarding liver enzyme normalisation (a measure of liver inflammation), the reported data shows figures ranging from approximately 70% to 82% across groups at one timepoint, and around 89% to 100% at week 156. The trial also measured kidney function over time using an estimated score called eGFR; the reported data shows varying changes from starting levels across the different groups, with some groups showing small increases and others showing decreases, though the specific meaning of these numbers was not further explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00289731 · results posted 3 October 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 596 adults across three groups, each receiving a different combination of hepatitis A and hepatitis B vaccines. The Twinrix group (199 participants) received a single combined vaccine, the Engerix-B + Havrix group (200 participants) received two separate vaccines made by one manufacturer, and the HB VAX PRO + Vaqta group (197 participants) received two separate vaccines made by another manufacturer. The trial was measuring how the body responded to each vaccination approach by looking at antibody levels — proteins the immune system produces — against both hepatitis A and hepatitis B. The reported data shows that, when looking at the number of participants whose antibody levels reached the defined threshold for hepatitis A, the counts were 176 (Twinrix), 180 (Engerix-B + Havrix), and 174 (HB VAX PRO + Vaqta). For hepatitis B antibody levels reaching the lower seropositivity threshold, the reported counts were 168, 152, and 137 participants respectively. When a stricter hepatitis B threshold was applied (considered a "seroprotection" level), the numbers were 166, 145, and 125 participants across the three groups. The reported average antibody concentrations (a measure of the overall level across the group) for hepatitis A were 2,746.5 units for the Twinrix group, 1,394.3 for Engerix-B + Havrix, and 3,707.2 for HB VAX PRO + Vaqta. For hepatitis B, the reported average concentrations were 1,153.9 for Twinrix, 491.2 for Engerix-B + Havrix, and 179.1 for HB VAX PRO + Vaqta. The reported data also shows results broken down by age and gender, though the detailed figures for each subgroup were not fully labelled to individual categories in the data submitted. Overall, six participants across the three groups did not complete the trial, and reasons were not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01651403 · results posted 19 September 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called tenofovir disoproxil fumarate (TDF) in children and adolescents with chronic hepatitis B (a liver infection caused by the hepatitis B virus). A total of 90 participants took part — 60 received TDF and 30 received a placebo (a dummy treatment with no active medicine). The trial ran in two phases: a blinded phase lasting up to 48 or 72 weeks (where neither participants nor doctors knew who was receiving which treatment), followed by an open-label phase up to week 192 (where everyone received TDF and knew they were doing so). The main thing the trial was measuring was the proportion of participants whose hepatitis B virus levels in the blood dropped below a very low threshold by week 48. The reported data shows that, by week 48, 76.7% of participants in the TDF group had hepatitis B virus levels in their blood fall below the target threshold, compared with 6.9% in the placebo group. For a secondary measure looking at a specific change in a hepatitis B protein marker in the blood (called HBeAg seroconversion — roughly meaning the body started producing a certain antibody response), the reported figures were 25.0% in the TDF group and 24.1% in the placebo group. The reported data also shows that normal liver enzyme levels (a marker of liver health called ALT) at week 48 were recorded in 51.7% of the TDF group and 17.2% of the placebo group, using one measurement standard, and in 65.0% versus 17.2% using a second measurement standard. By week 192 — after all participants had been on TDF — the reported normal ALT rates were 71.7% (those who had been on TDF throughout) and 51.7% (those who had switched from placebo to TDF), under one standard, and 80.0% versus 62.1% under the other standard. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00388674 · results posted 30 July 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 6,216 people in the entecavir (ETV) group and 6,162 people in a comparison group taking other anti-hepatitis B (anti-HBV) medications — a total of more than 12,000 participants. The trial was measuring three main things over time: how many people developed any type of cancer, how many people died, and how many people experienced their liver disease getting worse due to hepatitis B. A separate expert committee reviewed and confirmed each of these events. The reported data shows that for the main outcomes, 331 people in the entecavir group and 337 people in the comparison group developed any type of cancer. There were 238 deaths in the entecavir group and 264 in the comparison group. Liver disease worsening related to hepatitis B was recorded in 350 people in the entecavir group and 375 in the comparison group. For the additional (secondary) outcomes, the trial also looked at specific types of cancer: a liver cancer called HCC (hepatocellular carcinoma) occurred in 240 people in the entecavir group and 263 in the comparison group, while other cancers not involving the liver occurred in 95 versus 81 people respectively. Deaths directly related to liver disease were recorded in 46 people in the entecavir group and 48 in the comparison group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01368497 · results posted 3 July 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 adults who received a combination of two antiviral medicines — entecavir and peginterferon — for hepatitis B. The trial was measuring how many participants showed specific changes in their hepatitis B virus markers (proteins and virus levels in the blood) by the end of the study, as well as tracking how often unwanted health events occurred during treatment. Of the 60 people who started, 58 completed the trial and 2 did not finish. The reported data shows that for the main marker being tracked — losing a protein called HBeAg while also having very low virus levels in the blood — a proportion of 0.033 was recorded, meaning roughly 3 in every 100 participants met this combined result. For unwanted health events (called adverse events), the reported rate during treatment was 1.13 events per person-year, and 0.70 per person-year during the follow-up period after treatment ended. For more serious unwanted health events (serious adverse events), the reported rate was 0 during treatment and 0.01 per person-year during follow-up. Turning to the secondary markers, the reported data shows that approximately 5 in 100 participants lost a surface protein called HBsAg at one measured timepoint, and approximately 3 in 100 at another timepoint. Similarly, roughly 3 in 100 participants lost the HBeAg protein on its own. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02836236 · results posted 18 April 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 155 people with hepatitis B (a liver infection caused by the hepatitis B virus). Participants were randomly assigned in a blinded way — meaning neither they nor their doctors knew which medicine they were receiving — to take either TAF 25 mg (105 people) or TDF 300 mg (50 people) for 48 weeks. After that double-blind phase, those who completed it moved into an open-label phase where everyone took TAF. The trial was measuring how well each medicine reduced the amount of hepatitis B virus in the blood, as well as tracking changes in bone density and kidney markers. The reported data shows that at the 48-week mark in the double-blind phase, 89.4% of participants taking TAF and 98.0% of participants taking TDF had hepatitis B virus levels in their blood below a threshold of 29 IU/mL (a very low, hard-to-detect level). For bone density, the reported data shows that hip bone density changed by −0.718% in the TAF group and −1.096% in the TDF group, while spine bone density changed by +0.740% in the TAF group and −3.456% in the TDF group — meaning both groups showed some change from their starting measurements, in different directions or amounts. A kidney marker called serum creatinine (a substance the kidneys filter out) changed by +0.012 mg/dL in the TAF group and +0.030 mg/dL in the TDF group from the start of the trial. Regarding protein detected in urine (another kidney-related measure), 21.6% of TAF participants and 18.0% of TDF participants showed a mild level, while 2.9% and 4.0% respectively showed a moderate level; no participants in either group showed a severe level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01005407 · results posted 11 January 2018

  According to the results reported on ClinicalTrials.gov, this trial compared two hepatitis B vaccines — HEPLISAV and Engerix-B — in adults with type 2 diabetes, a group known to respond less well to standard hepatitis B vaccination. A total of 1,969 people were assigned to receive HEPLISAV (along with a placebo injection to keep the comparison fair), and 483 people received Engerix-B. The trial's main goal was to measure how many participants in each group developed what researchers call a "seroprotective immune response" — meaning their blood showed a level of hepatitis B antibodies considered sufficient for protection — eight weeks after their final dose. The reported data shows that, for the primary measure, 90.1% of participants in the HEPLISAV group reached that antibody level, compared with 70.5% in the Engerix-B group. For the secondary measure — reactions at the injection site or elsewhere in the body after the shots — the reported data shows a range of figures across multiple categories. In the HEPLISAV group, reported reaction rates across the different categories ranged from 0% to approximately 24%, while in the Engerix-B group they ranged from approximately 13% to 23%. Some of these figures likely reflect that participants in the HEPLISAV group received placebo injections at certain time points (recorded as 0%), which accounts for some of the variation seen in the numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01098006 · results posted 18 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people in total across four groups, all of whom completed the study with no drop-outs. The groups were: 7 people classed as "immune tolerant" (meaning their immune system was not actively fighting the hepatitis B virus), 11 people who were HBeAg-positive (a marker indicating active viral replication), 60 people classed as "inactive carriers" (carrying the virus but with little active disease), and 21 people who were HBeAg-negative (a different phase of chronic infection). The trial was measuring specific immune cells in the blood — in particular, a type of regulatory immune cell (called a "T-regulatory cell" or Treg) that can either calm down or allow immune responses. Researchers looked at how often these cells carried certain surface markers, which can indicate what the cells are doing. The reported data shows the counts of these regulatory immune cells (measured per million blood cells) across several different marker combinations, for each of the four participant groups. For one key measurement — regulatory cells carrying the Foxp3 protein along with activation markers — the reported figures ranged from roughly 4.2 to 6.3 cells per million across the four groups. For the broader group of CD4 immune cells that did *not* carry Foxp3, the reported figures were much higher, ranging from roughly 94 to 96 per million in that same measurement set. Additional measurements using different marker combinations showed similar patterns, with the Foxp3-positive (regulatory) cell counts consistently lower than the Foxp3-negative counts across all four participant groups. The reported data shows these numbers were broadly comparable across the four groups, though exact variation between groups was recorded for each marker combination. It is worth noting that because multiple measurement sets were reported, the figures above represent a selection of the reported results; all individual group values were provided in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01320943 · results posted 29 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people with hepatitis B who were already taking a antiviral medicine called tenofovir disoproxil fumarate (TDF). Participants were split into two groups: 21 people stopped taking TDF, and 22 people continued taking it. The trial ran for 144 weeks (about three years) and was mainly measuring whether stopping TDF led to a change in a protein on the surface of the hepatitis B virus — called HBsAg — which, if it disappears from the blood, is considered a significant marker in hepatitis B. Forty of the 43 participants completed the study. The reported data shows that, for the primary outcome — the proportion of participants whose HBsAg was no longer detected by week 144 — the figure was approximately 0.236 (roughly 24 in every 100) in the group that stopped TDF, and 0 in the group that continued TDF. For a secondary measure looking at whether the body then produced a protective antibody response (called seroconversion), the reported proportions were approximately 0.056 (around 6 in 100) in the stop-TDF group and 0 in the continue-TDF group at week 96, rising to approximately 0.203 (around 20 in 100) and 0 respectively by week 144. The reported data also shows that approximately 38 in every 100 participants in the stop-TDF group had restarted TDF therapy by week 144. Changes in the amount of HBsAg protein in the blood were small across all groups, and the data for some time points was reported as not available. The reported data also shows that liver enzyme levels (a marker that can indicate the liver is under stress) rose above the normal range in a notable proportion of participants who stopped TDF — particularly among those who eventually restarted the medication, where 100% were recorded above normal range at several time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00473668 · results posted 18 August 2017

  According to the results reported on ClinicalTrials.gov, this trial involved three groups of infants, each receiving a combination vaccine (Tritanrix-HepB/Hiberix) at different formulations — a standard version (Kft.), a low-dose version (LD), and a high-dose version (HD). Each group started with around 99–100 participants, and between 89 and 95 in each group completed the study. The trial was measuring how many children developed levels of antibodies — the body's defensive proteins — that met pre-set thresholds for several diseases covered by the vaccine: *Haemophilus influenzae* type b (Hib), hepatitis B, diphtheria, tetanus, and whooping cough (pertussis). The reported data shows the following participant counts reaching the antibody thresholds set by the researchers. For the Hib component (the primary measure), 93 participants in the Kft. group, 84 in the LD group, and 89 in the HD group met the threshold. For hepatitis B, the numbers were 92, 85, and 89 respectively. For diphtheria and tetanus measured together, the reported figures were 93, 85, and 88–89 depending on the measurement method used. Using a separate diphtheria-specific test, the numbers were 93, 85, and 89. For Hib at a higher antibody threshold, 88, 80, and 89 participants met the cut-off. For whooping cough, 92, 85, and 88 participants reached the threshold across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00291343 · results posted 3 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 296 children in total — 203 in one group and 93 in another. Both groups received a combination vaccine covering diphtheria, tetanus, whooping cough, hepatitis B, and Hib (a type of bacterial meningitis), plus a separate meningococcal vaccine (Mencevax ACWY). The two groups differed in which version of the combination vaccine was used. The trial was measuring the levels of certain antibodies — proteins the body produces in response to vaccination — against several bacterial strains, including two types of meningococcal bacteria (serogroups A and C) and hepatitis B. All 296 participants who started the study completed it. The reported data shows that, for the primary measure — the number of children reaching a specific antibody level against meningococcal serogroups A and C — 116 out of 203 children in the first group and 66 out of 93 in the second group met the threshold before a booster dose, while 192 out of 203 and 53 out of 93 met it after. For the secondary antibody measures, the reported data shows a range of results across different cut-off points and time points. For example, average antibody levels (called geometric mean titers, a way of averaging a wide spread of numbers) against meningococcal serogroup A were reported as 551.9 before boosting and 11,024.4 after boosting in the first group, compared with 469.1 and 437.2 in the second group. For hepatitis B, 164 out of 203 children in the first group and 59 out of 93 in the second group reached the specified antibody level. Some additional measurement breakdowns were reported in the data but the context for each individual figure (for example, exactly which time point each corresponds to) was not fully detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00158756 · results posted 12 July 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 308 infants across five groups, each receiving a different combination of childhood vaccines. The groups were: Tritanrix-HepB with Rotarix (80 started, 75 completed), Tritanrix-HepB with a placebo (25 started, 25 completed), Zilbrix with Rotarix (81 started, 73 completed), Zilbrix with placebo (23 started, 22 completed), and Triple Antigen with Engerix-B (99 started, 96 completed). The trial was measuring the levels of certain antibodies — proteins the body produces in response to vaccination — against diphtheria, hepatitis B, whooping cough (pertussis), and rotavirus (a common cause of severe diarrhoea in babies). The reported data shows that for the main outcome — antibody levels against diphtheria reaching a protective threshold — 100% of participants in four of the five groups met that threshold, while 98.9% did so in the Triple Antigen with Engerix-B group. For the secondary outcomes, the reported data shows the number of children whose antibody levels reached set thresholds for each disease. For hepatitis B antibodies, 64, 19, 58, 16, and 84 children met the threshold across the five groups respectively. For whooping cough antibodies, the numbers were 67, 19, 60, 16, and 79. For rotavirus antibodies, 42 children in the Tritanrix-HepB with Rotarix group and 41 in the Zilbrix with Rotarix group reached the threshold, while zero children in either placebo group did — rotavirus data was not reported for the Triple Antigen with Engerix-B group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00627458 · results posted 26 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 403 infants across three groups: the Infanrix Hexa PF group (127 started, 123 completed), the Infanrix Hexa PC group (137 started, 130 completed), and a Control group (139 started, 133 completed). The trial was measuring how many children in the two vaccine groups reached certain antibody levels — that is, levels of immune-system proteins in the blood — against diphtheria, tetanus, hepatitis B, and three types of poliovirus, at two different points in time (appearing to reflect measurements before and after vaccination or booster doses). The reported data shows the following numbers of participants who reached the defined antibody thresholds. For diphtheria and tetanus (threshold: 0.1 IU/mL): at the earlier time point, 22 of the PF group and 35 of the PC group met the threshold; at the later time point, 112–113 of the PF group and 118 of the PC group met it for both diphtheria and tetanus. For hepatitis B (threshold: 10 mIU/mL): at the earlier time point, 106 (PF) and 112 (PC) participants met the threshold, rising to 110 (PF) and 117 (PC) at the later time point. At a higher threshold of 100 mIU/mL, 55 (PF) and 54 (PC) met it at the earlier point, rising to 105 (PF) and 113 (PC) later. For poliovirus types 1, 2, and 3, at the earlier time point the numbers meeting the threshold ranged from 48 to 77 across the two groups and three virus types; at the later time point, 110–111 (PF) and 117 (PC) participants met the threshold for each virus type. It is worth noting that the data as submitted contains multiple measurement entries and some figures may reflect different sub-groups or time points that are not fully labelled in the structured data provided — where the exact context of a figure was unclear, it has been described as reported without interpretation. The Control group's antibody measurements were not reported in the outcome data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00936715 · results posted 2 June 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT00936715) involved 24 participants who all received a single treatment combination referred to as FTC/TDF (a medication containing two antiviral drugs in one tablet). Of the 24 people who started the study, 18 completed it, while 6 did not finish. The trial appears to have been a small, single-group study — meaning there was no comparison group — focused on access to and receipt of the study medication. The reported data shows that the only outcome measure listed was the number of participants who had access to and actually received the intervention. The result reported for this measure was 24 participants — that is, all 24 people who enrolled received the medication. Importantly, the study's own description notes that this endpoint was included only to meet the administrative requirements of ClinicalTrials.gov, and that there were **no pre-specified (planned in advance) endpoints** in this study. In other words, the trial was not designed to formally test or measure a specific health outcome, so no further numerical results from planned outcome measures were reported. Because no pre-specified outcome measures were included, the reported data does not contain figures on things like health changes, side effects, or other clinical results that are typical of larger trials. Any data beyond participant numbers was not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01171989 · results posted 11 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 391 infants across three groups. The first group (137 babies) received a combination vaccine called GSK2202083A along with Synflorix. The second group (133 babies) received Infanrix Hexa together with a meningococcal vaccine called Menjugate. The third group (121 babies) received Infanrix Hexa with two other vaccines, NeisVac-C and Synflorix. The trial was measuring how many babies in each group developed a level of antibodies — the body's natural defence proteins — considered high enough to offer protection against two specific bacteria: one that can cause a serious ear and throat infection (Haemophilus influenzae type b, targeted by the PRP measure) and one that can cause meningococcal disease (Neisseria meningitidis group C). The reported data shows that for the PRP (Hib) antibody measure, 132 out of 137 babies in Group 1, 126 out of 133 in Group 2, and 114 out of 120 in Group 3 reached the antibody level the researchers were looking for. For the meningococcal C antibody measure, the reported numbers were 131 out of 137 in Group 1, 124 out of 133 in Group 2, and 114 out of 120 in Group 3. Among the secondary (additional) measurements, one looked at a higher antibody threshold for meningococcal C protection at a later point in time: 117 out of 137 in Group 1, 92 out of 133 in Group 2, and 10 out of 120 in Group 3 reached that level. The reported data also includes average antibody levels across the groups, though some of these figures appear across multiple time points and a full breakdown of which number belongs to which time point was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00487747 · results posted 6 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants, all of whom received the treatment peginterferon alfa-2a. Seven participants completed the study, while 11 did not complete it. The trial was looking at markers of hepatitis B virus (HBV) activity in the blood — specifically, the amount of virus present (measured in "copies per mL," meaning the number of virus particles detected in a small volume of blood). Participants fell into two groups based on a protein linked to the virus: four were "HBeAg positive" and fourteen were "HBeAg negative," and the targets for acceptable virus levels differed between these two groups. The reported data shows that among the four HBeAg positive participants, all four had virus levels below 100,000 copies per mL at the relevant measurement point. Among the 14 HBeAg negative participants, three had virus levels below 20,000 copies per mL. For additional measurements in the HBeAg positive group, the reported data shows that all four had virus levels below 400 copies per mL, all four showed normalisation of a liver enzyme called ALT (a marker measured in blood to monitor the liver), and all four showed a sustained change in a specific hepatitis B protein marker (HBe seroconversion); however, none of the four showed a change in another marker called HBsAg seroconversion (where the surface antigen becomes undetectable). Among the 14 HBeAg negative participants, three had virus levels below 400 copies per mL, two showed HBsAg seroconversion, and three showed ALT normalisation. The reported data also shows that three participants experienced adverse events (unexpected health changes recorded during the study), and no participants experienced serious adverse events. Changes in ALT blood levels across the study period were also recorded at multiple time points, with reported mean (average) values ranging from approximately 37 to 109 IU/L (international units per litre) across different time points, though the specific time points for each measurement were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01940341 · results posted 30 March 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 426 adults with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were randomly assigned to take one of two antiviral tablets daily — either TAF 25 mg (285 people) or TDF 300 mg (141 people) — for an initial 48-week blinded phase, where neither participants nor researchers knew who was taking which medicine. Those who completed that phase then moved into an open-label extension where everyone took TAF. The trial was primarily measuring how many people had hepatitis B virus levels in their blood fall below a very low threshold (29 IU/mL, a standard cut-off used to indicate the virus is being suppressed) after 48 weeks. It also tracked changes in bone density and kidney markers. The reported data shows that at the 48-week mark, 94.0% of participants in the TAF group and 92.9% in the TDF group had hepatitis B virus levels below that threshold. For bone mineral density (a measure of bone strength), the TAF group showed an average change of −0.288% at the hip and −0.876% at the spine, while the TDF group showed average changes of −2.156% at the hip and −2.514% at the spine — meaning both groups showed some reduction, with the TDF group showing larger reductions on average. A kidney marker called serum creatinine changed by an average of +0.01 mg/dL in the TAF group and +0.02 mg/dL in the TDF group, both very small changes. Regarding protein detected in urine (a kidney monitoring measure), mild levels were reported in 18.1% of TAF participants and 16.4% of TDF participants; moderate levels in 1.1% and 2.1% respectively; and severe levels in 0% of both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01940471 · results posted 30 March 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01940471) compared two antiviral tablets — TAF 25 mg and TDF 300 mg — in people with chronic hepatitis B (a long-term liver infection). In the first, blinded phase (where neither participants nor doctors knew which tablet was being taken), 582 people were assigned to TAF and 293 to TDF. After 48 weeks, most participants moved into an open-label extension phase where everyone took TAF. The trial's main goal was to measure how many people had very low levels of the hepatitis B virus in their blood at the 48-week mark. The reported data shows that at 48 weeks, 63.9% of participants in the TAF group and 66.8% in the TDF group had hepatitis B virus levels below the threshold the trial was measuring (less than 29 IU/mL, a very low level). For a secondary measure looking at a specific immune response — where the body stopped reacting to a particular virus protein and developed a counter-response — the reported figures were 10.3% in the TAF group and 8.1% in the TDF group. The trial also measured changes in bone density in the hip and spine. The reported data shows the TAF group had a hip bone density change of −0.10% and spine change of −0.42% from their starting point, while the TDF group had changes of −1.72% (hip) and −2.29% (spine). A kidney marker called serum creatinine (a substance in the blood that can indicate how the kidneys are working) changed by +0.009 mg/dL in the TAF group and +0.026 mg/dL in the TDF group from baseline. The reported data also includes a measure of protein detected in urine (which can sometimes signal kidney stress). At the mild level, 23.9% of the TAF group and 17.8% of the TDF group had a treatment-related finding; at the moderate level, those figures were 3.5% and 4.5% respectively; and at the severe level, 0% and 0.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00169442 · results posted 28 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 745 infants or young children across six groups. The study was comparing different ways of mixing or combining vaccines that protect against diphtheria, tetanus, whooping cough (pertussis), hepatitis B, and a bacterial infection called Hib (caused by *Haemophilus influenzae* type b). The trial measured whether children's blood showed certain levels of protective proteins called antibodies — one for each disease — after receiving booster doses or a challenge dose of vaccine. The reported data shows the number of children whose antibody levels reached the pre-defined thresholds after vaccination. For the Hib-related antibody (anti-PRP), 39 out of 41 children in one group and all 41 out of 41 in the comparison group reached the lower threshold, while 37 and 39 respectively reached the higher threshold, one month after a challenge dose. In the booster-dose groups, between 71 and 88 children (depending on the group) reached each of the two Hib antibody thresholds. For diphtheria and tetanus antibodies, the reported data shows that 100% of children across all four booster groups reached the defined protective level for diphtheria, and between 68 and 88 children per group reached it for tetanus. For hepatitis B, between 69 and 84 children per group reached the defined threshold, and for whooping cough (pertussis), between 65 and 85 children per group did so. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00325143 · results posted 7 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 702 infants who all received the Infanrix Hexa vaccine — a combination vaccine given in multiple doses. Of those who started, 676 completed the trial and 26 did not finish. The trial was measuring how many children experienced certain symptoms after each dose of the vaccine, including local reactions at the injection site (pain, redness, and swelling) and general reactions across the whole body (drowsiness, fever, irritability, and loss of appetite). The reported data shows that, across the various doses given during the study, the number of participants recorded as experiencing any local symptom at the injection site ranged from 89 to 166 children per dose, while the number experiencing any general symptom (such as drowsiness or fever) ranged from 100 to 229 children per dose. These figures reflect how many children had any occurrence of each symptom, regardless of how mild or severe it was. For secondary measures, the reported data shows that 321 participants experienced at least one unsolicited adverse event — meaning an unexpected medical occurrence noted during the study period. No participants (0 out of 702) were reported as having a large swelling reaction at the injection site. The data also shows that 108 participants experienced a serious adverse event, which the trial defined as events such as hospitalisation, life-threatening occurrences, or disability — though the data as reported does not break down what those specific events were or whether they were considered related to the vaccine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00869778 · results posted 18 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 360 people across three groups — 120 received a higher dose of a treatment called εPA-44 (900 micrograms), 120 received a lower dose (600 micrograms), and 120 received a placebo (an inactive treatment). The trial was looking at people with hepatitis B, and its main goal was to measure how many participants experienced what is called "HBeAg seroconversion" — a change in a specific hepatitis B protein marker in the blood that can indicate a shift in the body's response to the virus. By the end of the study, 108, 113, and 110 participants respectively had completed the trial in each group. The reported data shows that, at the end of the study, 38.8% of participants in the higher-dose group, 28.6% in the lower-dose group, and 20.2% in the placebo group showed this protein marker change. The reported data also shows results tracked at several earlier time points — for example, by week 40, the figures were 22.4%, 20.2%, and 10.9% respectively. For a separate measure looking at the amount of hepatitis B virus detected in the blood (a drop of at least tenfold), the reported figures at the final time point measured were 49.1%, 55.5%, and 47.9% across the three groups. A liver enzyme measurement called ALT — which can reflect liver activity — returned to a normal range in 32.8%, 20.2%, and 20.2% of participants respectively at the last recorded time point. The reported data also shows that for one secondary measure — participants who tested negative for both a certain viral protein and its related antibody — the recorded figure was 0% across all groups and all time points. Results for the proportion of participants developing a specific protective antibody (anti-HBe) were also reported, reaching 31.0%, 31.1%, and 22.7% in the three groups at the final time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01358825 · results posted 29 December 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01358825) enrolled 58 participants in total — 12 in the Infanrix Hexa group and 46 in the Infanrix-IPV/Hib group. The trial was measuring how the immune systems of participants responded to vaccination, specifically by looking at the levels of antibodies (the body's natural defence proteins) produced against several diseases, including diphtheria, tetanus, whooping cough (pertussis), and hepatitis B. All 12 participants in the Infanrix Hexa group completed the study, as did 45 of the 46 in the Infanrix-IPV/Hib group (one did not complete). The reported data shows the following numbers for antibody levels after vaccination. For diphtheria and tetanus protection (measured using a standard threshold of 0.1 IU/mL, meaning a level considered to indicate a degree of immune response): 7 out of 12 participants in the Infanrix Hexa group and 28 out of 46 in the Infanrix-IPV/Hib group reached that threshold for diphtheria; for tetanus, those numbers were 10 out of 12 and 34 out of 46 respectively. Average antibody levels (a type of average that accounts for wide variation in numbers, called a geometric mean) were 0.13 and 0.196 IU/mL for diphtheria, and 0.29 and 0.352 IU/mL for tetanus, across the two groups. For the three whooping cough markers measured, the reported data shows that participant counts reaching the measurement threshold and average antibody levels varied across both groups and all three markers. For hepatitis B — which was only measured in the Infanrix Hexa group — the reported data shows 5 out of 12 participants reached the threshold level, with an average antibody level of 9 mIU/mL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00753649 · results posted 30 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 224 infants in total — 112 Aboriginal children and 112 non-Aboriginal children — across two groups in Australia. The trial was measuring how the body responded to the Infanrix Hexa vaccine, specifically looking at whether children developed certain antibody levels in their blood after vaccination. Antibodies are proteins the immune system makes that can recognise specific germs. The trial focused mainly on antibodies against two diseases: Haemophilus influenzae type b (Hib, a bacterial infection) and hepatitis B. Seven children in the Aboriginal group did not complete the trial; all 112 children in the non-Aboriginal group completed it. The reported data shows that for the main (primary) measure — the number of children who reached a Hib antibody level considered a key threshold (0.15 µg/mL or above) — 92 out of 105 Aboriginal children and 106 out of 112 non-Aboriginal children met this level. For a higher Hib antibody threshold (1 µg/mL or above), 83 Aboriginal and 91 non-Aboriginal children reached that level. The average antibody concentration for Hib (expressed as a geometric mean, a type of average used for this kind of data) was reported as 6.123 µg/mL for the Aboriginal group and 3.51 µg/mL for the non-Aboriginal group. For hepatitis B, 91 Aboriginal and 103 non-Aboriginal children reached the standard protective threshold (10 mIU/mL or above), and 89 Aboriginal and 100 non-Aboriginal children reached a higher threshold of 100 mIU/mL or above. The average hepatitis B antibody concentrations were reported as 1,797.9 mIU/mL for the Aboriginal group and 1,544.4 mIU/mL for the non-Aboriginal group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01095835 · results posted 3 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 128 adults with hepatitis B across three treatment groups. Fifty-one participants received a shorter course of a drug called pegylated interferon over 48 weeks (PEG-IFN48), 52 received a longer 96-week course of the same drug (PEG-IFN96), and 25 received the longer 96-week course combined with a second medicine called lamivudine (PEG-IFN+LAM96). The trial was measuring whether participants achieved a "combined response" — meaning that two things happened at the same time: their liver enzyme levels returned to a normal range, and the amount of hepatitis B virus detected in their blood dropped below a set threshold. Not everyone completed the study: 41, 40, and 17 participants respectively finished in each group. The reported data shows that, at the main measurement point (48 weeks after treatment ended), the percentage of participants who achieved the combined response was 11.8% in the 48-week group, 25.0% in the 96-week group, and 20.0% in the combination group. At the end of the treatment period itself, the reported figures were higher: 29.4%, 38.5%, and 32.0% respectively. At a midway check (24 weeks after treatment ended), the reported percentages were 23.5%, 28.8%, and 24.0%. The reported data also shows that a smaller proportion of participants showed improvement in liver tissue appearance on biopsy: 13.7% in the 48-week group, 5.8% in the 96-week group, and 8.0% in the combination group. Changes in a protein on the surface of the hepatitis B virus (called HBsAg) were also measured, and the reported data shows a decrease from the starting level in all three groups by the end of treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00436163 · results posted 24 October 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people with chronic hepatitis B (a liver infection caused by the hepatitis B virus) who were treated with a medicine called peginterferon alfa-2a. Of the 39 who started, 36 completed the trial and 3 did not finish. The trial was measuring how the virus behaved in participants' blood — specifically the levels of hepatitis B virus genetic material (called HBV-DNA) and certain proteins linked to the virus — at various points during and after treatment, including at Week 72 (roughly 18 months into follow-up). The reported data shows that for the primary outcomes — the main things the trial set out to measure — 6 out of the participants who started with higher virus levels and were "HBeAg positive" (meaning a particular virus protein was detectable in their blood) had virus levels drop below a set threshold by Week 72. Similarly, 6 participants who were "HBeAg negative" at the start (a different pattern of the same infection) had their virus levels fall below a different, lower threshold by Week 72. For the secondary outcomes — additional measurements the trial tracked — 4 participants had virus levels fall below a very low threshold of 400 copies per millilitre. Around 3% of participants no longer had a surface protein of the virus (called HBsAg) detectable in their blood at the measured time points, and around 8% and 3% (at two separate time points) had developed a protective antibody response against that surface protein. The average level of a liver enzyme called ALT — a marker sometimes used to indicate liver activity — was reported as approximately 62.6 and 64.5 units per litre at the two measured time points, though the specific time points for several of these secondary measurements were not fully detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01519960 · results posted 17 August 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 161 people in total across three groups. Group A had 101 participants who received a medication called PEG-interferon (a type of injection used in hepatitis B treatment) and did not have advanced liver scarring. Group B had 50 participants who received no treatment and also did not have advanced liver scarring. Group C had 10 participants who received PEG-interferon and did have advanced liver scarring. The trial was measuring several things related to hepatitis B virus (HBV) activity in the body, including whether certain proteins in the blood changed over the course of treatment — specifically looking at what happened 24 weeks after treatment ended. The reported data shows the following for the main result (called the primary outcome), which looked at a change in blood proteins known as "HBeAg seroconversion" — meaning a specific hepatitis B protein disappeared and a protective antibody appeared in its place: this was recorded in 25.7% of participants in Group A (those who received the medication) compared with 6% in Group B (those who received no treatment). For some of the other measurements taken at the same 24-week point after treatment: loss of that same protein without the antibody check was also 25.7% in Group A versus 6% in Group B; a different protein called HBsAg disappearing with an antibody appearing was recorded in 7.9% of Group A versus 0% in Group B; normal liver enzyme levels (ALT) were recorded in 51.5% of Group A versus 12% in Group B; and low levels of the virus in the blood were recorded in 33.7% (Group A) versus 4% (Group B) at one threshold, and 28.7% versus 2% at a stricter threshold. Results for Group C were not reported in these outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01340937 · results posted 2 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,808 infants across four groups. Three groups received different production batches (called "lots") of a combination vaccine called V419 — a single shot designed to protect against eight diseases including diphtheria, tetanus, whooping cough (pertussis), hepatitis B, and Hib disease (caused by *Haemophilus influenzae* type b). The fourth group received a separate control vaccine. The trial ran in three stages: an infant vaccination series, a waiting period, and a toddler booster dose. Around 2,286 children completed all three stages. The trial measured the levels of antibodies — the immune system's response proteins — that children's bodies produced after vaccination. The reported data shows the following antibody levels after vaccination. For the Hib component, the average antibody concentration (a type of average called a geometric mean, which accounts for wide variation in values) was 5.51, 6.10, and 6.59 micrograms per millilitre (µg/mL) for the three V419 lots combined to 6.05 µg/mL, compared with 3.76 µg/mL in the control group. For hepatitis B, the reported figures were 1,195–1,414 milli-international units per millilitre (mIU/mL) across the V419 lots, versus 609 mIU/mL in the control group. For tetanus, levels were 1.55–1.63 international units per millilitre (IU/mL) in the V419 groups versus 0.89 in the control. For pertussis toxin, figures ranged from 96.82 to 100.83 units per millilitre across V419 lots versus 82.45 in the control. For diphtheria, reported levels were similar across all groups (approximately 0.36–0.40 IU/mL). A secondary measure looked at the proportion of children whose antibody levels crossed two set thresholds for the Hib component; the reported data shows that 97.82–99.01% of children in the V419 lots reached the higher threshold (≥1.0 µg/mL), compared with 96.18% in the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01337167 · results posted 16 March 2016

  According to the results reported on ClinicalTrials.gov, this trial compared two vaccine groups in infants and toddlers: one group received a combination vaccine called V419, and the other received a control vaccine. A total of 986 infants started in the V419 group and 487 in the control group, with numbers reducing slightly over the course of the trial's three stages — an infant series, an interim period, and a toddler vaccination phase — as some participants did not complete each stage. The trial was measuring how many children in each group developed detectable levels of antibodies (proteins the body makes in response to vaccination) against six different diseases: Haemophilus influenzae type b (Hib), Hepatitis B, Diphtheria, Tetanus, and two components related to Whooping Cough (Pertussis). The reported data shows the percentage of children whose blood tests reached pre-set antibody levels after vaccination. For Hib, 84.97% of the V419 group and 75.39% of the control group reached the lower target level, while 97.25% and 92.41% respectively reached the higher target level. For Hepatitis B, 99.42% (V419) and 98.58% (control) reached the target level. For Diphtheria, the figures were 82.44% (V419) and 86.26% (control). For Tetanus, 99.87% (V419) and 99.49% (control) reached the target. For the first Whooping Cough measure (Pertussis Toxin), 98.12% (V419) and 98.47% (control) met the target, and for the second Whooping Cough measure (Filamentous Hemagglutinin), 87.31% (V419) and 92.07% (control) met the target. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00927082 · results posted 9 March 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 383 adults across four treatment groups, all receiving a medication called pegylated interferon (PEG-IFN) for hepatitis B. The groups differed by dose (90 micrograms or 180 micrograms) and by how long they received treatment (24 weeks or 48 weeks). The main thing the trial was measuring was a change in a hepatitis B marker in the blood called HBeAg — specifically, whether it disappeared and was replaced by a protective antibody (called anti-HBe), a process known as "seroconversion." Several other blood markers related to hepatitis B and liver health were also tracked. Between 320 and 320 participants completed the study out of 383 who started, with dropout numbers ranging from 10 to 22 across the four groups. The reported data shows that for the primary measure — HBeAg seroconversion — the percentage of participants who reached this milestone varied by group and by the point in time it was measured. Results were recorded at the end of treatment, at 24 weeks after treatment ended, and at 48 weeks after treatment ended. By the final follow-up point (48 weeks after treatment), the reported figures were: 26.9% in the 90mcg/24-week group, 37.1% in the 180mcg/24-week group, 30.2% in the 90mcg/48-week group, and 47.4% in the 180mcg/48-week group. For the secondary measures, the reported data shows similar patterns across groups. For example, the percentage of participants whose liver enzyme levels (ALT — a marker sometimes used to assess liver stress) returned to a normal range by the final follow-up were 58.1%, 60.7%, 55.7%, and 65.3% respectively. Changes in another surface marker (HBsAg seroconversion) were reported at low percentages across all groups, generally between 0% and 3.2% at the final follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00970216 · results posted 29 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people, all of whom had chronic hepatitis B (a long-term liver infection caused by the hepatitis B virus). The trial ran for 48 weeks and was measuring how many participants reached a specific level of virus in their blood — described as having fewer than 300 copies per millilitre of the hepatitis B virus's genetic material (HBV-DNA). Reaching this low level is the target that was being tracked as the main outcome. Of the 160 people who started, 80 completed the study and 80 did not complete it, though the reasons for not completing were not detailed in the reported data. The reported data shows that out of the participants measured for the main outcome, 79 people had virus levels below 300 copies per millilitre at the 48-week mark. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov, so no further results are available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00940485 · results posted 22 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT00940485) enrolled 197 adults with hepatitis B — 97 in a group receiving a combination of two antiviral medicines (peginterferon alfa-2a plus entecavir) and 100 receiving entecavir alone. The trial ran for 48 weeks and was mainly measuring a specific change in the blood called "HBeAg seroconversion" — this means the hepatitis B envelope antigen (a protein from the virus) disappeared from the blood and was replaced by a protective antibody against it. By the end of the study, 82 people in the combination group and 93 in the entecavir-only group had completed the trial. The reported data shows that for the main measurement at week 48, about 14.9% of participants in the combination group had the HBeAg seroconversion, compared with about 6.1% in the entecavir-only group. For the additional measurements, the reported data shows: roughly 62.8% in both groups lost the HBeAg marker from their blood; the proportion with very low virus levels in the blood (below 1,000 copies per millilitre) was about 62.8% in the combination group and 91.8% in the entecavir-only group; loss of a different virus protein called the surface antigen occurred in about 8.5% of the combination group and 0% of the entecavir-only group; and seroconversion of that surface antigen was seen in about 4.3% of the combination group and 0% of the entecavir-only group. The reported data also shows that a liver enzyme called ALT — which doctors use as a marker of liver stress — returned to a normal range in about 51.1% of the combination group and 85.7% of the entecavir-only group by week 48. These figures reflect what was recorded and reported for the study groups as a whole, and individual experiences would vary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00922207 · results posted 20 November 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 280 adults with hepatitis B across three groups. Ninety-one people received pegylated interferon alfa-2a (an injectable medicine) combined with adefovir (a tablet), 95 received the same injection combined with entecavir (another tablet), and 94 received the injection with a placebo (a dummy tablet with no active medicine). The trial ran for 100 weeks and was primarily measuring a specific immune response called "HBeAg seroconversion" — this means the body stops producing a particular hepatitis B protein (HBeAg) and begins producing an antibody against it, which is considered a notable change in the body's response to the virus. The reported data shows that at 100 weeks, the percentage of participants who achieved this immune response was 27.4% in the adefovir combination group, 29.5% in the entecavir combination group, and 36.3% in the placebo combination group. For the secondary outcomes, the reported data shows that the amount of hepatitis B virus detected in the blood (known as viral load, measured in copies per millilitre) fell across all three groups over time, with the entecavir combination group showing a somewhat larger reported reduction at several time points. The proportion of participants whose liver enzyme levels (ALT — a marker measured in blood to monitor liver health) returned to the normal range by week 100 was reported as 21.1%, 24.7%, and 20.7% across the three groups respectively. Notably, across all time points measured, the reported data shows that none of the participants in any group achieved a result where the main hepatitis B surface protein (HBsAg) disappeared from their blood and an antibody against it appeared — that figure was 0% in all groups at all time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00998426 · results posted 28 September 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, and all 5 completed the study with none dropping out. The trial was looking at whether a medication called HBIG (hepatitis B immunoglobulin) — which contains sugar as part of its formulation — affects blood glucose (blood sugar) readings. Specifically, it was comparing three different ways of measuring blood glucose: two types of finger-prick point-of-care devices (referred to as GNS-POC and GS-POC) and a standard venous blood draw (blood taken from a vein). Measurements were taken before the injection and then immediately after, at 60 minutes, and at 120 minutes after the injection. The reported data shows that the blood glucose measurements, recorded in mg/dL (milligrams per decilitre, a standard unit for measuring sugar in the blood), varied across the different time points and methods. The figures reported were: −3.2, 6.0, 56.6, −2.6, 7.4, 10.6, 17, and 11 mg/dL. These numbers appear to represent differences in blood glucose levels at various points before and after the injection across the different measurement methods. It is worth noting that the reported data does not clearly label which specific number corresponds to which time point or measurement method, so a precise breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01277601 · results posted 9 September 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 751 adults with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were split into four groups and given different treatment combinations: one group received two medicines together (tenofovir, or TDF, plus pegylated interferon, or Peg-IFN) for 48 weeks; a second group received TDF for 48 weeks but Peg-IFN for only the first 16 weeks; a third group received TDF alone for 120 weeks; and a fourth group received Peg-IFN alone for 48 weeks. The trial's main goal was to measure how many people in each group lost a specific protein on the surface of the hepatitis B virus — called HBsAg — by around week 72, since losing this protein is considered a notable marker in hepatitis B. The reported data shows that for the primary measurement at week 72, approximately 9.1% of participants in the TDF-plus-Peg-IFN (48-week) group had lost HBsAg, compared with about 2.8% in the Peg-IFN-alone group and 0% in the TDF-alone group. For the shorter combination (TDF 48 weeks plus Peg-IFN 16 weeks), the reported figure was approximately 2.8% — similar to the Peg-IFN-alone group. The reported data shows these figures remained broadly similar when checked again at weeks 96 and 120. For a related secondary measure — the body developing antibodies against that same surface protein (called seroconversion) — the TDF-plus-Peg-IFN (48-week) group showed figures of around 8.1% at weeks 72 and 96, rising to about 10.1% at week 120, while the other groups showed notably lower figures. Separately, the proportion of participants who lost another hepatitis B marker called HBeAg was also tracked; in those not requiring retreatment at week 72, figures ranged from roughly 14.7% to 35.5% depending on the group, with similar patterns seen at week 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02052661 · results posted 27 August 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 300 participants, all in a single group called the "Engerix-B Kinder Group." All 300 participants completed the study. The trial was looking at how the body responds to a booster dose of the Engerix-B Kinder hepatitis B vaccine in children around 12–13 years of age who had previously received hepatitis B vaccination as infants. The main thing being measured was whether participants developed a strong enough level of hepatitis B antibodies (proteins the immune system makes in response to a vaccine) in their blood — specifically, whether levels reached 100 mIU/mL or above. The reported data shows that 272 out of 300 participants reached that antibody level of 100 mIU/mL or above after the booster dose. Before the booster was given, the reported average antibody level across participants was 22.7 mIU/mL; after the booster, that average rose to 3,502.6 mIU/mL. The reported data also shows that before the booster, 205 participants had antibody levels at or above 6.2 mIU/mL (a basic detectable level), and 178 were at or above 10 mIU/mL. After the booster, those numbers rose to 283 and 282 respectively out of 300. Additionally, 277 out of 300 participants showed what the trial called an "anamnestic response" — meaning their immune system appeared to recognise and respond to the vaccine, either by reaching a detectable antibody level or by showing a large rise from their pre-booster level. The reported data also recorded some physical reactions at the injection site: 132 participants reported pain, 70 reported redness, and 29 reported swelling. No further detail about the nature or duration of these reactions was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01354652 · results posted 20 February 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01354652) enrolled a very small number of participants — 3 people in the Entecavir group and 2 people in the Lamivudine group, with no one enrolled in the comparison "no NRTI" group. None of the participants were recorded as having completed the study. The trial was measuring whether certain antiviral medications (Entecavir and Lamivudine, both belonging to a drug class called NRTIs) were linked to raised levels of lactate — a substance in the blood — in hospitalised patients with serious liver disease. High lactate levels can be a sign of a condition called lactic acidosis, which is a build-up of acid in the body. The reported data shows that for the primary (main) outcome — the number of participants who had a venous (blood) lactate level above 2 mmol/L for any reason — all 3 participants in the Entecavir group and both 2 participants in the Lamivudine group recorded this finding. For one of the secondary (additional) outcomes, the reported data shows a measure called "OLT-free survival" (the number of days participants survived without needing a liver transplant): an average of 411 days was reported for the Entecavir group and 175 days for the Lamivudine group. All other secondary outcome measures — including lactate levels specifically linked to the medications, lactate levels from other causes, other medications associated with lactic acidosis, and detailed blood chemistry readings — had no data reported on ClinicalTrials.gov. It is important to note that because so few people were enrolled and none formally completed the study, the numbers above represent a very limited dataset and should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01627340 · results posted 9 January 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01627340) looked at how the body responds to a hepatitis B vaccine in two groups of adults: 416 people with diabetes and 258 people without diabetes (the control group). The trial was primarily measuring how many participants developed a level of hepatitis B antibodies — proteins the immune system makes in response to the vaccine — considered high enough to be "seroprotected" (that is, reaching a threshold of 10 mIU/mL or above). A total of 404 people in the diabetes group and 254 in the control group completed the trial. The reported data shows that 285 out of the diabetes group participants and 155 out of the control group participants reached that antibody threshold. When looking at the average antibody levels across each group (reported as a geometric mean concentration, which is a type of average suited to this kind of data), the diabetes group recorded 147.6 mIU/mL compared to 384.2 mIU/mL in the control group. The reported data also shows that various symptoms after vaccination — such as pain, redness, or swelling at the injection site, as well as general symptoms like fatigue, headache, stomach upset, and fever — were tracked and recorded across both groups, with numbers of participants reporting these symptoms available for each group. For example, 160 participants in the diabetes group and 115 in the control group reported any local symptom. Regarding more serious medical events (defined as those involving hospitalisation, life-threatening illness, disability, or death), 16 participants in the diabetes group and 4 in the control group reported such an event during the trial period. It is important to note that the data above simply describes what was counted and measured — it does not on its own tell us why differences between groups occurred, and some additional detail on symptom breakdowns was listed in the raw data but not fully labelled by symptom type in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01327547 · results posted 14 November 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01327547) looked at a medicine called maraviroc compared to a placebo (a dummy treatment with no active ingredient) in 137 people — 70 in the maraviroc group and 67 in the placebo group. The trial ran for up to 144 weeks (roughly three years). Its main focus was on monitoring a liver enzyme called ALT (alanine aminotransferase), which doctors use as a marker to check on liver health. Specifically, the trial tracked how many participants had notably high ALT readings — described as "Grade 3 or 4" abnormalities, meaning levels that were substantially above the normal range. The reported data shows that for the primary measurement — the proportion of participants with those high ALT readings at 48 weeks — 1.4% of people in the maraviroc group and 1.5% of people in the placebo group had such readings. The reported data also shows results at later time points: at 96 weeks, it was 1.4% (maraviroc) versus 3.0% (placebo); and at 144 weeks, 2.9% (maraviroc) versus 4.5% (placebo). For a related measure looking at large rises in ALT from the starting point, the figures reported were 2.8% (maraviroc) versus 4.4% (placebo) for one sub-measure, and 1.4% versus 0.0% for another. The data on how long it took participants to develop these high ALT readings was listed as not available. For a combined liver marker check known as "Hy's Law," zero participants in either group met that threshold throughout the study. It is worth noting that 20 people in the maraviroc group and 22 in the placebo group did not complete the trial, and the reasons for that were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00362336 · results posted 2 May 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 622 infants across three groups. The first group (243 infants) received a combination vaccine called DTaP-IPV-Hep B-PRP~T, which aims to protect against diphtheria, tetanus, whooping cough, polio, hepatitis B, and a bacteria called Haemophilus influenzae type b (Hib). The second group (242 infants) received a similar set of protections through separate vaccines — CombAct-Hib™, Engerix B™, and oral polio vaccine. The third group (137 infants) followed the same combination vaccine schedule as the first group but also received an extra hepatitis B vaccine dose at birth. The trial's main aim was to measure how many children developed a level of antibodies — proteins the body makes in response to vaccines — considered sufficient for protection against each of the diseases targeted. The reported data shows that, after the primary course of vaccinations, the number of participants recorded as reaching the antibody threshold considered protective varied by disease and group. For example, across the three groups, the numbers reaching the hepatitis B threshold were reported as 176, 185, and 97 participants respectively; for the Hib threshold, 209, 212, and 119; for diphtheria, 201, 198, and 116; and for tetanus, 213, 210, and 122. The secondary outcomes tracked additional antibody measurements at higher threshold levels, average antibody levels (a type of average called a geometric mean titer), and how antibody levels held up before and after a booster dose. The reported data also recorded the number of children who experienced reactions at the injection site (such as redness or swelling) or general reactions (such as fever, crying, or irritability) — for instance, pain at the injection site was reported in 166, 177, and 95 participants across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00401531 · results posted 1 April 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 412 infants in total — 206 in each group. One group received a combination vaccine called DTaP-IPV-Hep B-PRP-T alongside Prevnar™, while the other group received a different combination vaccine called Infanrix Hexa™ also alongside Prevnar™. The trial was measuring how many infants developed detectable levels of antibodies (proteins the immune system makes in response to vaccination) against several diseases, including hepatitis B, Hib (a type of bacteria causing serious infections), diphtheria, tetanus, whooping cough (pertussis), and polio. Around 197–196 infants completed the trial in each group. The reported data shows that, for the primary measure — antibody levels against hepatitis B and Hib — 187 out of the DTaP-IPV-Hep B-PRP-T group and 189 out of the Infanrix Hexa™ group reached the threshold level for hepatitis B, while 183 infants in each group reached the threshold level for Hib. For the secondary measures, the numbers reaching the antibody threshold for diphtheria were 184 and 190 respectively, and for tetanus, 189 and 190. Against all three types of poliovirus, 187 and 186 infants (types 1 and 2), and 187 and 185 (type 3) reached the threshold in each group. For whooping cough, 177 infants in each group showed a sufficient antibody response for one component (pertussis toxoid), and 177 versus 179 for another component (FHA). The reported data also shows that injection-site reactions such as pain, redness, and swelling were recorded in a number of participants in both groups, with figures ranging across different reaction types, and some systemic reactions such as fever, crying, and irritability were also recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01463683 · results posted 17 February 2014

  According to the results reported on ClinicalTrials.gov, this trial looked at a hepatitis B vaccine (called V232) given in different ways and doses. A total of 722 people took part, split across three groups: 309 received a two-dose formulation injected under the skin (subcutaneous, or "SC"), 309 received a one-dose formulation the same way, and 104 received the two-dose formulation injected into the muscle (intramuscular, or "IM"). The trial measured how many people developed a level of hepatitis B antibodies considered "seroprotective" — meaning a blood antibody level thought to indicate the body had responded to the vaccine — and also tracked reactions at the injection site and fever. The reported data shows that, among the two subcutaneous groups, 90.1% of people in the two-dose SC group and 82.5% in the one-dose SC group reached the antibody level defined as seroprotective. Regarding reactions at the injection site (such as redness, swelling, or pain), 76.4% of the two-dose SC group, 71.4% of the one-dose SC group, and 65.4% of the IM group reported these events. For fever (defined as a temperature of 37.8°C or above), the reported figures were 3.2% in the two-dose SC group, 3.9% in the one-dose SC group, and 4.8% in the IM group. Seroprotection data for the IM group was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00315055 · results posted 4 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 310 infants in total — 155 in each group. One group received a single combination vaccine called DTaP-IPV-Hep B-PRP~T, which was designed to protect against six diseases in one injection. The other group received two separate vaccines — Pentaxim™ and Engerix B® — to cover the same diseases. The trial was measuring how well each approach produced detectable levels of protective antibodies (proteins the body makes in response to vaccination) against hepatitis B, diphtheria, tetanus, whooping cough (pertussis), polio, and a bacterial infection called Hib, after three doses given over the first few months of life. Most children completed the study — 152 in the combination vaccine group and 150 in the two-vaccine group. The reported data shows that for the main outcome — the proportion of children reaching a recognised antibody level for hepatitis B — 94% of children in the combination vaccine group and 96% in the two-vaccine group met that threshold. For the additional outcomes, the reported figures varied by disease and by the specific antibody level being measured. For polio (all three types), both groups reported seroprotection rates of 94–100%. For Hib, 91% (combination) versus 98% (two vaccines) met the lower threshold, and 100% in both groups met the higher threshold. For tetanus, 99% versus 97% met the threshold. For diphtheria, 73% versus 77% met the lower threshold. For whooping cough, 100% of participants in both groups showed a meaningful rise in antibodies to two key markers. The reported data also shows that some children in both groups experienced injection-site or general reactions (such as pain, redness, fever, or irritability), with numbers ranging across the three doses; for example, after the first dose, 70 children in the combination group and 55 in the two-vaccine group reported at least one such reaction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00343889 · results posted 10 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 379 infants in total — 190 in one group and 189 in the other. The study compared two different combination childhood vaccines, each given alongside an oral polio vaccine, across three doses. The main thing researchers were measuring was how many children developed a level of hepatitis B antibodies (proteins the body makes in response to vaccination) considered to indicate protection — specifically, a blood antibody level of 10 mIU/mL or above, measured 30 days after the third dose. A number of secondary measurements were also taken, including antibody responses to diphtheria, tetanus, whooping cough, and Hib (a type of bacteria), as well as reactions at the injection site and general symptoms after each dose. The reported data shows that for the primary outcome — reaching that hepatitis B antibody threshold of 10 mIU/mL — 146 out of 190 children in the DTaP-Hep B-PRP~T + OPV group and 167 out of 189 children in the Tritanrix-Hep B/Hib™ + OPV group met this level. For a higher hepatitis B antibody threshold of 100 mIU/mL, the reported data shows 54 children in the first group and 97 in the second group reached that level. For diphtheria and tetanus antibody responses, the numbers were broadly similar between groups. For whooping cough-related antibody responses, 183 children in the first group and 168 in the second showed a meaningful rise, while for a related antibody (filamentous hemagglutinin), 178 in the first group and 116 in the second showed a meaningful rise. The reported data also shows that injection site and general reactions were recorded across both groups, with numbers varying by reaction type and dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00514709 · results posted 14 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,843 children in total — 1,230 in one group who received a combination vaccine called DTaP-Hep B-PRP~T along with oral polio vaccine, and 613 in a second group who received a different combination vaccine called Tritanrix-Hep B/Hib™ also with oral polio vaccine. All enrolled children completed the study. The trial was measuring how well a booster dose of the DTaP-Hep B-PRP~T vaccine prompted the body to produce antibodies (proteins the immune system makes in response to vaccination) against several diseases, including diphtheria, tetanus, whooping cough, hepatitis B, and Hib (a type of bacterial infection). It also recorded the number of children who experienced reactions at the injection site or general reactions after the booster dose. The reported data shows that, for the primary outcome — the number of children who reached certain antibody levels after their booster — the counts varied by disease and by group. For example, for hepatitis B antibodies, 81 children in Group 1 and 80 in Group 2 met the target level; for tetanus, 93 (Group 1) and 103 (Group 2); and for diphtheria, 93 (Group 1) and 103 (Group 2). For the secondary outcome measuring average antibody levels (called geometric mean titers, a way of averaging measurements that vary widely), the reported figures also differed between groups depending on the disease being measured — for instance, hepatitis B titers were reported as 71.6 for Group 1 and 42.2 for Group 2, while diphtheria titers were 58.1 for Group 1 and 242 for Group 2. The reported data also shows the number of children who experienced injection site or general reactions after vaccination. In Group 1, 411 children reported pain at the injection site, compared with 216 in Group 2; 272 in Group 1 and 136 in Group 2 reported redness, and 211 in Group 1 and 120 in Group 2 reported swelling. Severe (Grade 3) reactions — defined by specific thresholds such as crying when the limb was moved, or redness/swelling of 5 cm or more — were reported in smaller numbers across both groups. These figures describe what was recorded and counted; they do not indicate whether any reaction rate is considered high or low. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00507507 · results posted 8 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 126 people with chronic hepatitis B — 64 in a group taking tenofovir DF (a single antiviral medicine) and 62 in a group taking a combination of two antivirals, emtricitabine (FTC) plus tenofovir DF. The trial ran for up to 192 weeks (roughly 3.5 years) of treatment, followed by a 24-week period without any treatment for some participants. The main thing the trial was measuring was the proportion of participants whose hepatitis B virus (HBV) levels in the blood fell below a specific low threshold (400 copies per millilitre) by the end of the treatment period. The reported data shows that at week 192, approximately 54.7% of participants in the tenofovir DF alone group and 75.8% in the combination group had HBV levels below that threshold. At earlier time points, the reported figures for the single-medicine group were 40.6% (week 48), 53.1% (week 96), and 62.5% (week 144), compared with 59.7%, 75.8%, and 80.6% in the combination group at those same points. When a stricter, lower threshold was applied (169 copies per millilitre), the reported percentages were generally lower across both groups at all time points. The trial also tracked the overall reduction in HBV levels from the start of treatment — both groups showed a large drop in virus levels by week 48, and this reduction was maintained through weeks 96 and 144, with the reported figures being broadly similar between the two groups at those later time points. It is worth noting that a sizeable number of participants did not complete the full treatment period — 52 people in each group — for reasons not detailed in this data. The 24-week treatment-free follow-up period was started by 26 participants from the tenofovir DF group and 29 from the combination group, with smaller numbers completing it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00106964 · results posted 28 June 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 371 young people living with HIV across three groups. Each group received a different hepatitis B vaccination approach: 118 participants received a standard 20 microgram dose of Engerix, 126 received a higher 40 microgram dose of Engerix, and 127 received a 20 microgram dose of Twinrix (a combined hepatitis A and B vaccine). The trial was primarily measuring how many participants in each group showed a blood-level response to the hepatitis B component of the vaccine, tested four weeks after their third vaccination. A "response" meant a certain level of hepatitis B antibody was detected in the blood. The reported data shows that, at the main measurement point, 60% of participants in the standard Engerix group showed a blood-level response, compared with 73.2% in the higher-dose Engerix group, and 75.4% in the Twinrix group. The reported data also looked at how long responses lasted among those who had responded at the main measurement point. Across all three groups, roughly 61–64% of those initial responders still showed a response beyond 44 weeks. Smaller proportions had responses that faded earlier than that point. The trial also recorded adverse events (unwanted health occurrences) and abnormal laboratory results across the three groups as secondary measures. The reported data shows very low numbers of clinical adverse events considered possibly, probably, or definitely related to the vaccinations across all arms, with most categories recording zero to two events per group. Abnormal laboratory results graded as moderate or above were also recorded, ranging from five to nine events per group in one category. Some individual sub-category figures were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00435825 · results posted 25 June 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 551 adults across four groups, all of whom had hepatitis B infection (specifically the type where a marker called HBeAg is present in the blood). Participants were given injections of a medicine called peginterferon alfa-2a at one of two doses — a lower dose (90 micrograms) or a higher dose (180 micrograms) — and for one of two treatment lengths: 24 weeks or 48 weeks. The main thing the trial was measuring was whether, 24 weeks after finishing treatment, participants showed a specific change in their blood called "HBeAg seroconversion" — meaning the HBeAg marker had disappeared and a different marker (anti-HBe) had appeared in its place, which researchers used as a sign of an immune response to the virus. The reported data shows that for the primary outcome — HBeAg seroconversion measured 24 weeks after the end of treatment — the percentages of participants who met this result were: about 14% in the lower-dose 24-week group, about 23% in the higher-dose 24-week group, about 26% in the lower-dose 48-week group, and about 36% in the higher-dose 48-week group. For the secondary outcomes, the reported data shows similar patterns. When the same seroconversion measure was checked at week 72 of the overall study period, the figures were roughly 18%, 27%, 26%, and 36% respectively across the four groups. Separately, the proportion of participants whose blood showed normal liver enzyme levels (a marker of liver activity) 24 weeks after treatment was approximately 30%, 31%, 43%, and 52% across the four groups. Changes in another blood marker called HBsAg were also measured; the reported figures for loss of that marker ranged from 0% to about 2%, and full seroconversion of that marker ranged from 0% to about 2% depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00303316 · results posted 22 February 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 458 infants in total — 232 in one group and 226 in the other. The study was comparing two different vaccination approaches given at 2, 4, and 6 months of age. One group received a single combined vaccine (DTaP-IPV-HepB-PRP~T) covering six diseases, while the other group received two separate vaccines (PENTAXIM™ plus ENGERIX B®) to cover the same diseases. Both groups then received a booster dose at 18 months of age. The trial measured how many children still had detectable levels of antibodies (the body's immune markers) before the booster shot, how many showed a strong antibody response after the booster, and what reactions children had around the injection site or generally after the booster. The reported data shows that before the booster was given at 18 months, the number of children with antibody levels above the pre-set thresholds varied by disease and by group. For example, for Hepatitis B, 195 children in the combined vaccine group and 221 in the two-vaccine group were above the threshold, while for the Hib (PRP) component the numbers were 171 and 164 respectively. After the booster dose, the reported data shows that large numbers of children in both groups reached the defined response levels across all measured diseases — for example, for the diphtheria component, 216 children in the combined vaccine group and 214 in the two-vaccine group met the response threshold, and similar patterns were reported for tetanus, polio, and pertussis components. Average antibody levels (a measure of how much antibody was present across the group) were also recorded before and after the booster, with figures reported for each disease component in both groups. The reported data also shows that in terms of reactions following the booster, 112 children in the combined vaccine group and 117 in the two-vaccine group reported at least one injection-site or general reaction. More detailed numbers were recorded for specific reactions such as redness, swelling, fever, crying, and irritability, at both standard and more severe ("Grade 3") levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00313911 · results posted 19 November 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 2,133 participants in total — 1,422 in the group receiving the combination vaccine called DTaP-IPV-Hep B-PRP\~T, and 711 in the group receiving a different combination called Tritanrix-Hep B/Hib™ together with oral polio vaccine (OPV). The trial was measuring how often high fever (defined as a rectal temperature of 39.6°C or above) occurred after vaccination, as well as how the body's immune response to hepatitis B compared between the two groups. By the end of the study, 1,328 participants in the first group and 670 in the second group had completed the trial. The reported data shows that, across the different vaccination visits, the number of participants recorded with a high fever ranged from 5 to 56 in the DTaP-IPV-Hep B-PRP\~T group, and from 4 to 39 in the Tritanrix-Hep B/Hib™ + OPV group, depending on the dose occasion. For the hepatitis B immune response, the reported average antibody levels (a measure of the body's response, expressed as a titre — essentially a score showing how much antibody was detected) were 1,075 for the first group and 3,376 for the second group. When looking at the proportion of participants who reached certain antibody thresholds considered protective against hepatitis B, the reported data shows 100% of participants in both groups reached the lower threshold, while 96% in the first group and 99% in the second group reached the higher threshold. The reported data also shows that the number of participants who experienced at least one recorded reaction at the injection site or elsewhere in the body varied across vaccination visits — for example, at one visit, 831 participants in the first group and 574 in the second group reported at least one such reaction, while at another visit those numbers were lower. These reactions included things like pain, redness, swelling, fever, vomiting, crying, drowsiness, loss of appetite, and irritability, each with defined thresholds for what was counted as severe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00410202 · results posted 4 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 415 people with hepatitis B who had previously been treated with a medicine called lamivudine but whose virus had become harder to control with that drug. Participants were divided into three groups: 138 people received a combination of entecavir and adefovir, 140 received entecavir alone, and 137 received a combination of adefovir and lamivudine. The trial was measuring the level of hepatitis B virus (HBV) in participants' blood — specifically, how many people in each group had their virus drop to a very low level (below 50 IU/mL, a standard cut-off used in blood tests) after 48 weeks of treatment, and again at 96 weeks. The reported data shows that at 48 weeks (the main measurement point), 25.4% of participants in the entecavir-plus-adefovir group, 16.4% in the entecavir-alone group, and 19.7% in the adefovir-plus-lamivudine group had virus levels below that cut-off. By 96 weeks, those figures had risen to 43.5%, 39.3%, and 28.5% respectively. The trial also measured how many participants reached two even lower virus-level thresholds. At 48 weeks, using a slightly stricter cut-off, 25.4%, 13.6%, and 16.8% reached that level across the three groups; at 96 weeks the figures were 38.4%, 36.4%, and 25.5%. At the strictest threshold tested, 20.3%, 11.4%, and 11.7% reached that level at 48 weeks, rising to 33.3%, 27.1%, and 20.4% at 96 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00395018 · results posted 31 May 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people who were all treated with a medication called entecavir (ETV) for hepatitis B. There was only one group — no comparison group. The trial ran for up to 72 weeks of active treatment, followed by an off-treatment follow-up period for some participants. Of the 65 who started, 55 completed the on-treatment phase; 10 did not finish before the 72-week mark. Only 5 participants entered the follow-up period, and just 1 completed it. The main thing the trial was measuring was the level of hepatitis B virus (HBV) in the blood at week 72, specifically whether it was detectable above a certain threshold using a sensitive laboratory test. The reported data shows that, for the primary measure, 0% of participants had detectable HBV in their blood at or above the 50 IU/mL threshold at week 72 — meaning the virus was below that level in all participants assessed at that point. For a liver enzyme called ALT (a marker sometimes associated with liver activity), the reported average level started at 158.7 U/L and was recorded at lower levels across later time points, with figures such as 61.2, 28.4, 28.4, 41.2, 24.9, 30.6, and 26.9 U/L at various follow-up assessments — though the specific time points for each reading were not included in the data provided. The reported data also shows that 96.7% of participants had lost a hepatitis B surface marker (HBsAg) by week 72. Among participants who were HBeAg-positive at the start, 100% had lost that particular viral protein by week 72, though 0% developed the corresponding antibody response (called seroconversion). The percentage of participants with low HBV levels at the end of the off-treatment follow-up period was not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00371150 · results posted 16 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 46 participants in total — 40 identified as Black or African American and 6 identified as Hispanic. The study was looking at how participants with hepatitis B responded over 48 weeks (about one year) to a medicine called entecavir (ETV). The trial tracked several things in the blood, including the level of the hepatitis B virus (called HBV DNA), liver enzyme levels (a marker of liver activity), and changes to certain hepatitis B proteins. The reported data shows that at the 48-week mark, about 12.5% of Black/African American participants and 13.0% of all participants combined had hepatitis B virus levels in the blood fall below the lowest measurable amount (meaning the virus was at such a low level the test could not reliably put a number on it). Around 72.5% of Black/African American participants and 69.6% of all participants had virus levels that were detectable but low (below 300 copies per millilitre of blood), while none fell into a mid-range category. Importantly, none of the participants in either group showed what the researchers called a "virologic rebound" — a confirmed rise in virus levels while still taking the medicine. For liver enzyme normalisation (a blood measure of liver activity returning to a typical range), the figure was approximately 67.5% for the Black/African American group and 67.4% overall. Among participants who had a particular hepatitis B protein present at the start (called HBeAg), around 50% of Black/African American participants and 53.8% overall lost that protein by week 48, and approximately 40.9% and 46.2% respectively showed what is called "seroconversion" — losing that protein and developing an antibody response against it. It is worth noting that the Hispanic group was very small (only 6 participants), and the reported data does not appear to include separate figures broken out for that group in the outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00805675 · results posted 28 February 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people with hepatitis B and divided them into three groups: 16 received telbivudine alone, 14 received tenofovir disoproxil fumarate (another antiviral) alone, and 16 received both medicines together. The trial was measuring how much the amount of hepatitis B virus in the blood (called "viral load") changed over 12 weeks, and tracking several other related markers along the way. Almost all participants finished the study — only one person in the combination group did not complete it. The reported data shows that by week 12, the viral load in the blood had fallen in all three groups. Viral load is measured on a "log10" scale, where each whole number represents a tenfold change. The telbivudine-alone group showed an average drop of about 3.85 units on this scale, the tenofovir-alone group dropped by about 4.18 units, and the combination group dropped by about 4.37 units. The reported data also shows that reductions were seen at earlier time points (weeks 2, 4, and 8), with the numbers getting larger as time went on across all three groups. However, at week 12, none of the participants in any group had their virus fall below the very lowest detectable level (fewer than 25 copies per millilitre of blood), and none showed loss of a particular virus marker called HBeAg — meaning those figures were 0% across all groups. The reported data also includes some technical measurements describing how quickly the virus was being cleared from the body in the very early days of treatment, with estimated clearance rates of 0.98, 1.19, and 1.08 (per day) for the telbivudine, tenofovir, and combination groups respectively. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information was not reported there. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00410072 · results posted 3 February 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 379 adults with hepatitis B — 182 in a group taking a medicine called entecavir (ETV) alone, and 197 in a group taking entecavir combined with a second medicine called tenofovir (TDF). The main thing the trial was measuring was what proportion of participants had their hepatitis B virus reduced to a very low level (below 50 IU/mL, a standard threshold used in blood tests) after 96 weeks of treatment. A number of secondary measurements were also tracked, including virus levels at earlier time points, liver enzyme levels in the blood, and how many participants had the virus reduced to even lower detection thresholds. The reported data shows that at the 96-week mark — the primary endpoint — 76.4% of participants in the entecavir-only group and 83.2% in the combination group had virus levels below that low threshold. For secondary measures, the reported data shows that when participants were split by a particular blood marker called HBeAg status, the proportions achieving low virus levels ranged from around 61% to 93% depending on the group, the time point (48 or 96 weeks), and HBeAg status. Using an even stricter detection threshold, between roughly 58% and 77% of participants across both groups had virus levels that fell below the lowest detectable limit at various time points. For liver enzyme (ALT) normalisation — a measure of whether a liver-related marker returned to a normal range — the reported figures ranged from approximately 68% to 83% across the two groups at weeks 48 and 96. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01138098 · results posted 21 December 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 185 children in total — 95 in one group (called the Infanrix-hexa/Engerix-B group) and 90 in another (the Infanrix-IPV+Hib/Engerix-B group). All enrolled children completed the study with no drop-outs recorded. The trial was measuring how children's immune systems responded to a booster (challenge) dose of a hepatitis B vaccine, given after they had already received their primary childhood vaccinations. Specifically, it looked at the level of hepatitis B antibodies (proteins the body makes in response to the vaccine) in children's blood, using a laboratory test that was updated during the study to improve accuracy. The reported data shows that, for the main outcome — the number of children whose antibody levels reached at least 100 mIU/mL (a specific measurement unit for antibodies) after the booster dose — 88 out of 95 children in the first group and 84 out of 90 in the second group reached that level. For one of the secondary outcomes, which looked at whether children showed a meaningful "anamnestic response" (meaning their immune system appeared to recognise and respond strongly to the booster), 91 children in the first group and 86 in the second group met that definition. Other secondary measures looked at antibody levels at different thresholds before and after the booster dose, and at local reactions at the injection site (such as pain, redness, and swelling), with between 8 and 30 children in each group reported to have experienced each of those reactions. It is important to note that some measurements in the data appear to reflect readings taken at two different time points (before and after the booster), though the specific time-point labels were not included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00076336 · results posted 5 September 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 116 participants in each of two groups — one group received a medicine called telbivudine (600 mg) and the other received lamivudine (100 mg), both existing antiviral treatments for hepatitis B. The trial was measuring what researchers called a "clinical response" — a combined result where a participant's hepatitis B virus levels in the blood dropped below a set level, their liver enzyme (ALT) readings returned to a normal range, and their liver function score (measured by a tool called the Child-Turcotte-Pugh or CTP score, which runs from 5 to 15, with higher numbers meaning more liver damage) either stayed stable or improved. Participants were followed for up to 104 weeks (about two years). The reported data shows that, looking at the primary outcome, the numbers of participants recorded as achieving a clinical response at various points were broadly similar between the two groups. For the secondary outcomes, the reported data shows the average time until a participant first reached a clinical response was around 138 days in the telbivudine group and 125 days in the lamivudine group. The reported duration that a clinical response was maintained averaged around 473 days for telbivudine and 456 days for lamivudine. For changes in the CTP liver function score at week 52, the reported data shows 36 telbivudine participants and 44 lamivudine participants showed improvement, 60 and 52 respectively showed stabilisation, and 18 in each group showed worsening. At week 104, 44 and 46 showed improvement, 42 and 38 showed stabilisation, and 28 and 30 showed worsening. A number of other sub-measures were also reported, with similarly close figures between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00142298 · results posted 25 July 2011

  According to the results reported on ClinicalTrials.gov, this trial (NCT00142298) was a long-term follow-on study involving people who had previously taken part in earlier hepatitis B trials. Participants were grouped based on which earlier study they came from and which treatment they had received — either telbivudine (LdT) or lamivudine (LAM), two medicines used in the management of hepatitis B. In total, across all groups, 1,869 people started the study. The trial was measuring whether participants could maintain a "therapeutic response" over time — meaning their hepatitis B virus levels in the blood stayed low (below a certain threshold) and they showed either a loss of a particular virus marker called HBeAg, or their liver enzyme levels (ALT) returned to a normal range. The reported data shows the main results for two of the groups. Among participants who had previously taken telbivudine (the LdT Pool group), the percentage who maintained a therapeutic response across four reported time points was 67.2%, 73.8%, 81.7%, and 86.3%. Among participants who had previously taken lamivudine (the LAM Pool group), the reported percentages across the same four time points were 60.1%, 65.3%, 80.8%, and 81.0%. The exact time points for these measurements were not specified in the data provided. For the several secondary outcome measures listed — including longer-term virus levels, clinical outcomes, durability of HBeAg responses, and resistance patterns — no numerical results were reported in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00289913 · results posted 7 July 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 1,271 young children across two stages. The children were split into five groups that received the hepatitis A vaccine (VAQTA™) in different combinations and timing alongside two other childhood vaccines — one for Haemophilus influenzae type b (a bacteria that can cause serious infections in young children), known as PedvaxHIB™, and one for diphtheria, tetanus and whooping cough, known as Infanrix™. The trial was measuring how the body responded — in terms of detectable antibody levels in the blood — to each of these vaccines, and also recording how many children experienced adverse events (unwanted reactions) after vaccination. The reported data shows that, for the hepatitis A component, 100% of children in each of the four Stage 1 groups had detectable hepatitis A antibodies at the measured level four weeks after their second VAQTA™ dose. For the Haemophilus influenzae type b component, between 97.0% and 98.1% of children across the four groups had antibody levels above the measured threshold after vaccination. For the whooping cough vaccine components (three different antibodies were measured), the reported average antibody levels ranged from 51.7 to 69.2 units per millilitre for one component, 249.2 to 253.8 for a second, and 333.5 to 358.5 for the third, across the two groups that received Infanrix™. Regarding adverse events, the reported data shows that across the three broadly defined safety groupings, between 63 and 181 children had adverse events considered possibly related to the vaccine, while larger numbers — up to 466 — had any adverse event recorded; the data does not break down the nature or severity of these events in the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00095121 · results posted 3 June 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 173 participants in total — 115 in the group that received the active medicine (adefovir dipivoxil, or ADV) throughout the study, and 58 in the group that started on a placebo before switching to the active medicine at week 48. The trial was studying a medicine for chronic hepatitis B virus (HBV) infection in children and adolescents. It ran in two stages: a blinded phase lasting about 48 weeks (where participants did not know which treatment they were receiving), followed by an open-label phase lasting up to around 240 weeks (where everyone received the active medicine). The main thing being measured was the proportion of participants whose hepatitis B virus levels in the blood dropped very low — below 1,000 copies per millilitre — and whose liver enzyme levels (a rough indicator of liver inflammation) returned to a normal range, both measured at week 48. The reported data shows that, at the primary measurement point of week 48, 19% of participants in the active medicine group and 2% in the placebo group had both very low virus levels and normal liver enzyme readings. At earlier check-in points within that same 48-week period, the proportions were lower — reported as 5% versus 0% at one earlier timepoint, and 0% for both groups at the very start. For the secondary measurements taken later in the open-label phase, the reported data shows that at the equivalent of 192 weeks on the active medicine, around 15% of participants in each group had virus levels below 1,000 copies per millilitre, and around 11–13% had virus levels below an even lower threshold of 400 copies per millilitre. At 240 weeks on the active medicine (available only for the group who started on ADV from the beginning), the reported figure was 6%. At the very start of ADV treatment, the reported data shows 0% in both groups met either of the lower virus-level thresholds. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00376259 · results posted 17 May 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 22 in a combination therapy group and 21 in an adefovir monotherapy group — to study treatments for hepatitis B virus (HBV) infection. The trial was designed to run for 96 weeks and aimed to measure things like whether the virus developed resistance to treatment (called "virologic breakthrough"), changes in the amount of virus in the blood, and certain blood test results. However, the reported data shows that the trial was ended earlier than planned, with the agreement of European regulators, meaning no participants formally "completed" the study as originally designed. As a result, the main question the trial set out to answer — about viral resistance by week 96 — could not be properly assessed. The reported data shows that for the secondary outcome measuring the amount of hepatitis B virus in the blood (recorded in scientific units called log10 copies/mL), both groups started at similar levels (around 10.2 for combination therapy and 10.1 for monotherapy). By 48 weeks, the combination therapy group showed an average reduction of about 5.8 units from their starting point, compared to about 4.6 units in the monotherapy group. By 60 weeks, those figures were approximately 6.6 and 5.0 units respectively. Regarding specific blood test results, the reported data shows that at some point during the study, around 38.5% of participants in the combination therapy group lost a particular virus marker called HBeAg, compared to 0% in the monotherapy group. Figures for other markers — including undetectable virus levels, liver enzyme normalisation, and surface antigen changes — were also reported across both groups, with numbers generally ranging from 0% to around 55% depending on the measure and group. For the two key outcomes — the proportion of people who experienced virologic breakthrough and the proportion with treatment-related resistance mutations — the reported data shows that no results were provided, because the trial ended too early to carry out those planned analyses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00984139 · results posted 1 March 2011

  According to the results reported on ClinicalTrials.gov, this trial (NCT00984139) enrolled 306 participants, all of whom completed the study. There was a single group, all receiving the Engerix-B hepatitis B vaccine. The trial was measuring how many participants developed a certain level of antibodies against hepatitis B — specifically, antibodies at or above a threshold of 100 mIU/mL (a unit used to measure the amount of antibody in the blood) — using two different laboratory testing methods. The reported data shows that when antibody levels were measured using a method called ELISA, 266 out of 306 participants had antibody concentrations at or above the 100 mIU/mL threshold after receiving a follow-up "challenge" dose of the vaccine. When measured using a second method called CLIA, 257 out of 306 participants reached that same threshold. The reported data also shows antibody counts at lower thresholds and at earlier time points across both testing methods, with varying numbers of participants reaching those levels at different stages of the study. Regarding reported symptoms, 104 participants reported pain at the injection site, 56 reported redness, 26 reported swelling, 63 reported fatigue, 56 reported headache, 14 reported gastrointestinal (stomach-related) symptoms, and 9 reported fever. Additionally, 64 participants reported other, non-pre-specified events during the study period. Whether these numbers were considered high or low in context was not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00289770 · results posted 23 February 2011

  According to the results reported on ClinicalTrials.gov, this trial followed a single group of participants who had previously received the Twinrix vaccine — a combined hepatitis A and hepatitis B vaccine. The study tracked these participants over several years (Years 11 through 15 after their original vaccination), with between 37 and 50 people attending each yearly check-in. The trial was measuring whether participants still had detectable levels of antibodies in their blood — antibodies being the proteins the immune system produces in response to vaccination — against both hepatitis A and hepatitis B. The reported data shows that, for hepatitis A antibodies, the number of participants whose levels were at or above the threshold (15 mIU/mL, a measure of antibody concentration) ranged from 23 to 31 people across the five yearly timepoints. For hepatitis B antibodies, the number at or above the threshold of 10 mIU/mL ranged from 20 to 28 people at each timepoint. The average antibody concentrations (a way of summarising the typical level across the group) were also reported: for hepatitis A, these ranged from approximately 525 to 680 mIU/mL across the years; for hepatitis B, the reported averages ranged from roughly 149 to 476 mIU/mL depending on the year and the laboratory test used. Two participants whose hepatitis B antibody levels fell below the threshold received an extra dose of a hepatitis B vaccine (Engerix), and the reported data shows both of those participants showed an "anamnestic response" — meaning their antibody levels rose significantly after that extra dose. Regarding reported symptoms at follow-up visits, the data shows very few participants (at most one per symptom category) reported any of the tracked local or general symptoms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00403585 · results posted 24 November 2010

  According to the results reported on ClinicalTrials.gov, this trial involved 104 participants, all of whom received a medicine called adefovir dipivoxil. The trial ran in two phases over a total of 156 weeks (about three years). The main thing being measured was the level of hepatitis B virus (HBV) in participants' blood, and how much that level changed over time. A number of secondary measurements were also tracked, including liver enzyme levels, certain markers in the blood related to the hepatitis B virus, and the number of participants who experienced adverse (unwanted) events. The reported data shows that, on average, the amount of HBV detected in participants' blood (measured using a scientific scale called log10 copies/mL) started at 7.94 at the beginning of the study and fell to 3.89 by week 156 — a reported average decrease of 4.16 on that scale. Regarding liver enzyme levels (called ALT — a marker that can indicate liver stress), the reported data shows that 63 participants had their ALT return to the normal range by week 104, and 65 by week 156. For what the researchers called a "virological response" (meaning the virus dropped to a very low, hard-to-detect level), 20 participants reached this point at week 104, rising to 24 at week 156. Changes in specific hepatitis B blood markers were also reported: at week 156, 27 participants showed loss of a marker called HBeAg, and 12 showed what is called HBeAg seroconversion (meaning a different antibody appeared in its place). Only 1 participant showed loss of a marker called HBsAg, and none showed HBsAg seroconversion. The reported data also shows that during the trial, 43 participants experienced at least one adverse event (an unwanted or unexpected health issue), and 2 participants experienced a serious adverse event. No further detail about the nature of these events is included in this summary data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00393484 · results posted 18 November 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 120 participants in total — 56 in the entecavir (0.5 mg) group and 64 in the lamivudine (100 mg) group. Both groups also received a placebo alongside their active medicine, so neither group knew which drug they were taking. The trial was looking at how well each medicine reduced the amount of hepatitis B virus in participants' blood, and also tracked liver enzyme levels and any unwanted health events (called adverse events) that occurred along the way. The trial ran in two phases: a double-blind period up to Week 96, followed by an open-label period through to Week 240. The reported data shows that the main thing being measured — the proportion of participants whose hepatitis B virus levels dropped to a very low level (below 300 copies per millilitre of blood) by Week 24 — was 92.86% in the entecavir group and 67.19% in the lamivudine group. The reported data also shows that the average reduction in virus levels in the blood (measured on a scientific scale called log10) was 3.58 for entecavir and 2.95 for lamivudine at Week 24, with similar patterns reported at later time points. A liver enzyme called ALT, which can rise when the liver is under stress, had a reported average level of 31.5 units per litre in the entecavir group and 43.26 units per litre in the lamivudine group at Week 24. Regarding unwanted health events, the reported data shows that no deaths occurred in either group during the trial. Serious adverse events were reported for 0 participants in the entecavir group and 3 in the lamivudine group up to Week 24. Common adverse events (those affecting 3 or more participants) were reported in 14 participants in the entecavir group and 23 in the lamivudine group, while severe or very severe adverse events were reported in 3 and 7 participants respectively. These numbers describe what was recorded and reported — they do not on their own tell us whether any event was caused by the medicines being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00347009 · results posted 15 October 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 155 people with chronic hepatitis B (a long-term liver infection), all of whom received a daily 10 mg dose of a medicine called adefovir dipivoxil. Of those 155 participants, 128 completed the study, while 27 did not finish. The trial ran for 36 months (3 years) and was primarily measuring whether the medicine was associated with an improvement in liver scarring (fibrosis), as assessed by a specialised liver scoring system called the Ishak fibrosis score, where a lower score means less scarring. The reported data shows that, for the primary outcome, 52 out of 155 participants showed an improvement in their liver scarring score at the 36-month mark. For the secondary outcomes, the trial also tracked the amount of hepatitis B virus (HBV) in participants' blood. The reported data shows that the number of participants whose virus levels fell to a very low threshold (1,000 copies per millilitre or below) was 91 at 12 months, 99 at 24 months, and 102 at 36 months. Using a slightly higher threshold (10,000 copies per millilitre or below), those figures were 110, 114, and 109 participants respectively. The trial also measured a liver health score called the Child-Pugh score; the reported data shows that very few participants — 0 at month 12, 2 at month 24, and 1 at month 36 — showed a meaningful improvement (a drop of 2 or more points) in that score. Additionally, 64 out of 155 participants showed a meaningful reduction in a separate measure of liver inflammation (the Knodell necroinflammation score) by month 36. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00289744 · results posted 26 August 2010

  According to the results reported on ClinicalTrials.gov, this trial followed people who had previously received the combined hepatitis A and B vaccine Twinrix, tracking them over several years (years 6 through 10 after their original vaccination). The main things being measured were the levels of antibodies — proteins the body produces in response to vaccination — against both hepatitis A and hepatitis B in the blood. A smaller group of participants who had lost detectable hepatitis B antibodies also received an additional dose of a hepatitis B-only vaccine (Engerix-B) to see how their bodies responded. In total, 178 people were followed in the Twinrix group across the long-term follow-up, 19 adults and 6 children/adolescents took part in the additional dose phase, and all participants who started each stage completed it. The reported data shows that antibody levels against hepatitis A in the Twinrix group were measured at 692.3, 753.6, 544.4, 479.5, and 601.6 milli-international units per millilitre (a standard unit for measuring antibody levels) across years 6 to 10 respectively. Hepatitis B antibody levels in the same group were reported as 206.2, 157.5, 102.7, 89.1, and 80.7 milli-international units per millilitre across those same years. For the additional dose phase, all 19 adults and all 6 younger participants were recorded as having met the study's definition of an immune response after receiving the extra Engerix-B dose. The reported data shows that zero participants in the Twinrix long-term follow-up group had serious adverse events (unexpected harmful medical events) considered related to the original vaccination across all five follow-up years. Regarding the additional dose group, the reported data shows that among adults, 6 out of 19 reported pain at the injection site, 2 reported redness, 1 reported swelling, 2 reported fatigue, none reported fever, and 2 reported headache. Among the younger participants, 3 out of 6 reported pain, 1 reported redness, none reported swelling, 3 reported fatigue, 1 reported fever, and 1 reported headache. Any other symptom details not captured in these categories were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00605384 · results posted 10 August 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00605384) enrolled only 2 participants in total — one person in a group receiving a combination of entecavir and tenofovir, and one person in a group receiving adefovir plus continuing lamivudine. All four of these are antiviral medicines used to treat hepatitis B. The trial was designed to measure how well each combination reduced the amount of hepatitis B virus (HBV) in the blood over time, particularly looking at whether virus levels dropped below certain thresholds at 48 weeks and again at 96 weeks. Neither participant completed the study. The reported data shows that results for the primary outcome — the number of participants whose hepatitis B virus levels fell below 50 IU/mL at week 48 — were not reported in the submitted data. Similarly, the data was not reported for most of the secondary outcomes, including virus levels at week 96, detailed virus level ranges at either time point, and average reductions in virus levels over time. The only secondary outcome with numbers reported was the count of participants who experienced any adverse events (unexpected medical occurrences during the trial): the reported data shows that 1 participant in each group experienced at least one adverse event. No serious adverse events, and no withdrawals due to adverse events or abnormal test results, were reported for either participant. Because this trial enrolled just 2 participants and neither completed the study, the submitted data is very limited, and most of the planned measurements were not able to be reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00240526 · results posted 15 July 2010

  According to the results reported on ClinicalTrials.gov, this long-term follow-up trial tracked children who had received hepatitis B vaccinations (using a vaccine called Engerix-B) shortly after birth, with or without an additional treatment called hepatitis B immunoglobulin (HBIg). The children were divided into four groups depending on whether they received three or four doses of the vaccine, and whether they also received HBIg. The trial followed these participants over several years — from year 15 through to year 20 after their original vaccination — with roughly 13 to 22 children assessed in each group at each annual check-in. The main things being measured were the level of hepatitis B antibodies (proteins the body produces in response to the vaccine) remaining in participants' blood, and whether any participants showed signs of hepatitis B infection. The reported data shows that antibody levels, measured in units called mIU/mL and expressed as a "geometric mean concentration" (a type of average that accounts for the wide spread of individual results), varied across the four groups at each time point. For example, at one measurement point using one laboratory method (ELISA), the four-dose plus HBIg group recorded an average of 118.6 mIU/mL, the three-dose plus HBIg group recorded 14.8 mIU/mL, the four-dose vaccine-only group recorded 142.8 mIU/mL, and the three-dose vaccine-only group recorded 24.2 mIU/mL. These figures shifted somewhat across the different yearly check-ins and depending on which laboratory testing method was used. The reported data also shows the number of participants whose antibody levels were above certain threshold values, and the number showing any signs of hepatitis B infection markers in their blood. Across the six years of follow-up, the number of participants with positive infection markers ranged from 0 to 9 depending on the group and the specific marker being checked, with the reported data showing 0 cases of confirmed chronic infection in most groups. Regarding signs of possible contact with the hepatitis B virus over the follow-up period, the reported data shows varying numbers of participants across groups who showed patterns that researchers categorised as a "possible subclinical breakthrough infection" (meaning a potential low-level exposure detected through blood markers, without necessarily causing illness) or an "isolated natural booster" (a rise in antibody levels that may suggest brief, limited contact with the virus). For instance, possible subclinical breakthrough infection was recorded in 9 participants in the four-dose plus HBIg group, 12 in the three-dose plus HBIg group, 4 in the four-dose vaccine-only group, and 10 in the three-dose vaccine-only group. No cases meeting the definition of chronic hepatitis B infection were reported in any group across the study period, though the trial's data as submitted does not provide further clinical detail beyond these counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00116805 · results posted 19 May 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 266 people in total — 176 in a group that received a medicine called tenofovir disoproxil fumarate (TDF) throughout the study, and 90 in a group that started on a different medicine called adefovir (ADV) before switching to TDF. The trial was looking at a liver condition caused by the hepatitis B virus (HBV). It measured two main things: whether the amount of hepatitis B virus in the blood dropped below a certain level, and whether tissue from a liver biopsy (a small sample taken from the liver) showed improvement in inflammation and scarring scores. The study ran in a blinded phase for the first 48 weeks, then continued as an open-label phase (where everyone knew which medicine they were receiving) for several more years, with some participants followed for up to 480 weeks (roughly nine years). The reported data shows that at the 48-week mark — the main measurement point — 66.5% of participants in the TDF-TDF group and 12.2% in the ADV group met the combined goal of having a very low virus level in the blood and showing improvement on the liver biopsy scoring system. Looking at the virus level alone at Week 48, 76.1% of the TDF-TDF group and 13.3% of the ADV group had readings below the target threshold. The reported data shows that by Week 96 (after the ADV group had switched to TDF), the proportions with low virus levels were similar between the two groups — 77.6% and 77.9% respectively. At later time points, the percentages with low virus levels generally ranged from the mid-50s to low 70s across both groups through to Week 384, then rose to the 90s–100% range among those still participating at Weeks 432 and 480, though the reported data notes that far fewer participants remained in the study at those later stages. Measurements of how much the virus level changed from the starting point were reported in a technical unit (log₁₀ IU/mL); figures for some of the later time points were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00117676 · results posted 19 May 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 382 adults with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were split into two groups: 254 people received tenofovir (TDF) throughout the study, while 128 people started on adefovir (ADV) for the first 48 weeks before switching to tenofovir. The trial ran for up to 480 weeks (roughly nine years) and tracked two main things: the level of hepatitis B virus in the blood, and changes in liver tissue seen under a microscope from a biopsy. The reported data shows that at the 48-week mark — the main measurement point — 70.8% of participants in the TDF-TDF group and 48.8% in the ADV-TDF group met the combined goal of having very low virus levels in their blood (below 400 copies per millilitre) alongside an improvement in liver tissue appearance. Looking at virus levels alone at week 48, the reported figures were 93.2% for the TDF-TDF group and 63.2% for the ADV-TDF group. By week 96 (after the ADV group had switched to TDF), the reported virus suppression figures were closer together: 90.6% and 89.3% respectively. The reported data also shows that among the smaller number of participants still in the study at weeks 432 and 480, the proportion with low virus levels was reported as 97.6%–100% across both groups at those later time points, though far fewer people were being measured by that stage. For the change in virus levels from the start of the study, the data was not reported for all time points in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00096785 · results posted 6 January 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in the entecavir group and 34 people in the adefovir group — 69 participants in total. Both entecavir and adefovir are antiviral medicines used to treat chronic hepatitis B, a liver infection caused by the hepatitis B virus. The trial was primarily measuring how much the level of hepatitis B virus in the blood (called "viral load") changed after 12 weeks of treatment. Viral load was measured using a sensitive test called PCR, with results expressed on a logarithmic scale (meaning each whole number represents a tenfold change). The reported data shows that at 12 weeks, the average viral load in the entecavir group had fallen by 6.23 units on the log scale, compared to a fall of 4.52 units in the adefovir group. By 48 weeks, the reported reductions were 7.28 units for entecavir and 5.08 units for adefovir. The data also shows that at 48 weeks, 19 out of 36 participants in the entecavir group had viral loads that dropped below the detectable limit of the test (below 300 copies per millilitre of blood), compared with 6 out of 33 in the adefovir group. For a liver enzyme called ALT — which can be elevated when the liver is under stress — 25 participants in the entecavir group and 20 in the adefovir group had their levels return to within the normal range. Additional modelling of how quickly the virus declined suggested the entecavir group had a virus clearance rate of 1.70 per day versus 0.91 per day for adefovir, though the data was not reported in a way that allows further interpretation here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00684671 · results posted 3 December 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 506 adults across three groups to compare different hepatitis A and B vaccination combinations. The Twinrix group had 172 participants, the Engerix + Havrix group had 170, and the HB VAX PRO + Vaqta group had 164. All participants had previously completed a primary course of hepatitis A and B vaccination, and the trial was measuring how their immune systems responded — specifically, how their antibody levels (proteins the body makes in response to vaccination) reacted when given a further "challenge" booster dose years later. The reported data shows that for the hepatitis A antibody response to the challenge dose, 164 participants in both the Twinrix group and the Engerix + Havrix group, and 162 in the HB VAX PRO + Vaqta group, met the pre-defined response criteria. For hepatitis B antibody response, 156 participants in the Twinrix group, 148 in the Engerix + Havrix group, and 136 in the HB VAX PRO + Vaqta group met those criteria. The reported antibody concentration levels (a measure of how much of the antibody was detected in the blood) varied across the groups and across different time points, with figures ranging widely — for example, hepatitis B antibody concentrations in the Twinrix group were reported as notably higher at some time points compared to the other groups. Regarding symptoms reported after the challenge dose, 42 Twinrix, 35 Engerix + Havrix, and 46 HB VAX PRO + Vaqta participants reported solicited local or general symptoms (such as pain at the injection site, headache, or fatigue), while 28, 10, and 21 participants respectively reported additional unsolicited symptoms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00393523 · results posted 12 October 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,478 participants across five groups. Most participants were children who had received a three-dose course of a hepatitis B vaccine (either RECOMBIVAX HB™ or ENGERIX-B™) during infancy, and who were now receiving a booster dose — either a modified process hepatitis B vaccine or ENGERIX-B™. A small fifth group of 20 participants received the modified process vaccine as a primary (first-time) course. The trial was measuring how many participants developed a certain level of hepatitis B antibodies — proteins the body produces in response to vaccination — in their blood four weeks after receiving the booster dose. Between 1,446 and 1,478 participants started the study, and between 1,446 and 1,478 completed it, with small numbers not finishing in each group. The reported data shows that, among participants who had originally received RECOMBIVAX HB™ in infancy, 323 out of those in the modified process booster group and 305 out of those in the ENGERIX-B™ booster group reached the target antibody level (≥10 mIU/mL — a standard threshold used to measure antibody response). For participants who had originally received ENGERIX-B™ in infancy, the reported data shows 329 in the modified process booster group and 313 in the ENGERIX-B™ booster group reached that same threshold. The trial also reported average antibody levels (a measure called geometric mean titre, or GMT, which is a way of averaging values that can vary widely). For the RECOMBIVAX HB™ infancy group, the reported GMTs were 476.9 mIU/mL (modified process booster) and 561.2 mIU/mL (ENGERIX-B™ booster). For the ENGERIX-B™ infancy group, the reported GMTs were 1,424.0 mIU/mL (modified process booster) and 1,216.1 mIU/mL (ENGERIX-B™ booster). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00657657 · results posted 14 September 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 29 participants, all in a single group who received the Engerix hepatitis B vaccine. All 29 participants completed the study. The trial was measuring how the immune system responded to a "challenge dose" — a follow-up shot of hepatitis B vaccine given to people who had been vaccinated years earlier — to see whether the body still had the ability to mount a protective immune response over the long term. The reported data shows that 28 out of 29 participants showed an immune response to the challenge dose, as defined by the trial's criteria (either a significant rise in hepatitis B antibody levels, or antibody levels reaching a set threshold, depending on where each person's levels stood beforehand). For the secondary measurements, all 29 participants had antibody levels above the lowest cut-off value tested, 28 were above the middle cut-off, and 27 were above the highest cut-off. The reported average antibody concentration (a type of group average that accounts for the wide spread of individual values) among those who tested positive after the challenge dose was 1,082.4 mIU/mL — mIU/mL being the unit used to measure the amount of these antibodies in the blood. The reported data also shows that zero participants reported unexpected medical events (called adverse events) and zero reported serious adverse events during the study period, though it is important to note that this was a small group of only 29 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00463437 · results posted 3 August 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,437 infants across four groups, each receiving a different combination of childhood vaccines. The four groups were: GSK's experimental 10-valent pneumococcal vaccine (1024850A) paired with one of three meningococcal vaccines (Meningitec™, NeisVac-C™, or Menitorix™), or the established pneumococcal vaccine Prevenar™ paired with Menitorix™. The trial was measuring how often children in each group experienced high fever and other symptoms after vaccination. Between 350 and 355 children completed the study in each group. The reported data shows that the main (primary) thing being tracked was the number of children who developed a rectal temperature above 39.0°C after vaccination. Results for this measure were only reported for two of the four groups: 11 children in the GSK vaccine + Menitorix™ group and 8 children in the Prevenar™ + Menitorix™ group — data for the other two groups was not reported. For the secondary measures, the trial also tracked local reactions at the injection site (such as pain, redness, and swelling), general symptoms (such as drowsiness, irritability, and loss of appetite), and any unexpected medical events. The reported data shows that local symptoms were recorded in roughly 134 to 196 children per group depending on the symptom, general symptoms in roughly 105 to 191 children per group, and unexpected medical events in 59 to 76 children per group. Serious medical events — defined as those involving hospitalisation, life-threatening situations, or similar — were reported in 2 to 5 children per group in one reporting period, and 9 to 15 children per group in another reporting period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00440297 · results posted 8 July 2009

  According to the results reported on ClinicalTrials.gov, this trial compared two hepatitis B vaccines — an experimental "Modified Process Hepatitis B Vaccine" and an already-approved vaccine called ENGERIX-B™. A total of 277 people started the trial (139 in the modified vaccine group and 138 in the ENGERIX-B™ group), with 116 and 120 people respectively completing all four visits. The trial was measuring how many participants developed a level of hepatitis B antibodies considered protective (a blood antibody level of 10 mIU/mL or above), as well as tracking certain reactions after vaccination. The reported data shows that after the third dose (at the 7-month mark), 49 out of those assessed in the modified vaccine group and 64 out of those assessed in the ENGERIX-B™ group reached that antibody level. After a fourth dose (at the 9-month mark), the reported numbers were 66 participants in the modified vaccine group and 72 in the ENGERIX-B™ group. The trial also tracked injection-site reactions, with 43 people in the modified vaccine group and 48 in the ENGERIX-B™ group reporting at least one such reaction. A raised temperature of 100°F (37.8°C) or above was reported in 5 people in the modified vaccine group and 6 in the ENGERIX-B™ group. The reported data shows that zero participants in either group experienced a serious adverse event considered related to the vaccine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00524576 · results posted 8 July 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 144 adults in total — 97 in one group and 47 in another. All participants had previously received a hepatitis B vaccine (called Engerix) and were given a "challenge dose" (an extra booster shot) to see how their immune system responded. One group had originally received 2 doses of the vaccine before the challenge dose, and the other group had originally received 3 doses. The trial was measuring whether the immune system produced enough of a particular antibody — called anti-HBs — after the challenge dose. This antibody is the body's response to hepatitis B vaccination. The reported data shows that, for the primary measure, 53 out of 97 participants in the 2-dose group and 21 out of 47 in the 3-dose group showed the level of immune response being tracked after the challenge dose. For secondary measures, the average antibody concentration (a measure of how much antibody was present in the blood) was reported as 6,214 units per millilitre in the 2-dose group and 16,564 units per millilitre in the 3-dose group. When looking at antibody levels above various cut-off points, 50 and 53 participants in the 2-dose group, and 20 and 21 in the 3-dose group, met those thresholds depending on the cut-off used. The reported data also shows that some participants reported symptoms after the challenge dose. In the 2-dose group, 22 people reported pain at the injection site, 11 reported redness, and 9 reported swelling. In the 3-dose group, 4 reported pain, 1 reported redness, and none reported swelling. For general symptoms such as fatigue, headache, and gastrointestinal (stomach-related) issues, 19 participants in the 2-dose group and 7 in the 3-dose group reported fatigue, and 14 and 4 respectively reported headache. Additionally, 19 participants in the 2-dose group and 5 in the 3-dose group reported other unplanned medical events during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00197184 · results posted 4 June 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 276 participants split into two groups — 139 received Twinrix Adult and 137 received Twinrix Junior, a combined hepatitis A and hepatitis B vaccine. All 276 participants completed the study. The trial was measuring the levels of antibodies (proteins the body produces in response to vaccination) against both hepatitis A and hepatitis B in the blood over a long-term follow-up period, and also tracked what happened if participants' antibody levels dropped below certain thresholds and they received an additional vaccine dose. The reported data shows that antibody levels against hepatitis A were measured in units called mIU/mL across several time points. For the Twinrix Adult group, these readings ranged from 1,122.2 mIU/mL down to 576.8 mIU/mL over time, while the Twinrix Junior group recorded readings ranging from 1,377.8 mIU/mL down to 698.4 mIU/mL. For hepatitis B antibodies, the Twinrix Adult group recorded readings ranging from 479.9 down to 150.2 mIU/mL, and the Twinrix Junior group from 830.6 down to 283.7 mIU/mL. For participants whose hepatitis B antibody levels dropped very low and who received an extra booster dose, the reported data shows that antibody levels before the booster were 4.9 mIU/mL (Adult group) and 2.4 mIU/mL (Junior group), rising to 521.3 and 509.7 mIU/mL respectively afterwards. No data was reported for hepatitis A antibody levels following an additional dose. The data for the additional hepatitis A dose outcome was not reported. Regarding the secondary outcomes, the reported data shows that zero participants in either group experienced a serious adverse event (an unexpected medical occurrence resulting in serious harm, hospitalisation, or similar) that was considered by the investigators to be related to the vaccination. Among participants who received an additional vaccine dose, the reported data shows that 6 participants in the Twinrix Adult group and none in the Twinrix Junior group reported any local symptom (such as pain, redness, or swelling) at the injection site, with no severe pain reported in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00240500 · results posted 1 May 2009

  According to the results reported on ClinicalTrials.gov, this trial followed up 109 people across six groups who had previously received a hepatitis B vaccine. The six groups reflected different vaccination schedules or formulations that participants had originally received. The study was checking in on those participants roughly 17 to 20 years after their original vaccination — the year-16 check-in was missed due to a delay in protocol approval. The trial was measuring three main things: the level of hepatitis B antibodies still present in the blood, whether any blood markers of hepatitis B infection had appeared, and whether anyone had developed a chronic (long-term) hepatitis B infection. The reported data shows that antibody levels (measured in units called mIU/mL) varied across the six groups and across the years measured. At the year-17 and year-18 check-ins, the reported group averages ranged from as low as 10.6 mIU/mL to as high as 143.4 mIU/mL at year 17, and from 19.2 to 121.6 mIU/mL at year 18. Figures for years 19 and 20 were not reported in the data submitted. Regarding infection markers, the reported data shows that the large majority of participants across all groups — between approximately 94% and 100% — did not show blood markers associated with past hepatitis B infection at the time points measured. A small proportion in two groups (6.3% in one group and 3.7% in another) did show such markers. As for chronic hepatitis B infection, the reported data shows that two participants (one each in two separate groups) met the definition of chronic carrier at one point during the study, and none were recorded as chronic carriers at a later reported time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00414050 · results posted 14 April 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,718 participants across four groups, each receiving a different hepatitis B vaccine: a modified process hepatitis B vaccine at either a 5 microgram or 10 microgram dose, an existing licensed vaccine called RECOMBIVAX HB™, or another existing vaccine called ENGERIX-B®. Each group had around 427–431 people at the start, and the vast majority — over 419 in each group — completed the trial. The trial was primarily measuring what proportion of participants developed a detectable level of hepatitis B antibodies in their blood after vaccination (a level considered to indicate the immune system had responded to the vaccine). The reported data shows that the percentage of participants who reached that antibody level was very high across all four groups. In the 5 microgram modified process vaccine group, 99.3% reached that level; in the RECOMBIVAX HB™ group, 98.5%; in the 10 microgram modified process vaccine group, 100%; and in the ENGERIX-B® group, 99.5%. The trial also measured the average amount of antibody present in participants' blood after vaccination. The reported data shows these average antibody levels (expressed in standard laboratory units called mIU/mL) were 748.2 for the 5 microgram modified process vaccine group, 376.8 for the RECOMBIVAX HB™ group, 981.5 for the 10 microgram modified process vaccine group, and 556.6 for the ENGERIX-B® group. These figures describe what was measured in the trial; they do not indicate anything about what any individual person's response might be. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00440531 · results posted 31 March 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 540 adults across three groups who each received three doses of a hepatitis B vaccine. The groups were: a new "modified process" hepatitis B vaccine (185 people), an already-approved vaccine called RECOMBIVAX-HB™ (183 people), and another already-approved vaccine called ENGERIX-B™ (172 people). The trial was measuring how many people in each group developed a level of hepatitis B antibodies — proteins the body makes in response to vaccination — considered to indicate protection (specifically, a blood level of 10 mIU/mL or above). Blood samples were taken before the first dose and one month after the third dose. The reported data shows that, by the end of the vaccination course, 115 out of the modified process vaccine group reached that antibody level, compared with 100 out of the RECOMBIVAX-HB™ group and 121 out of the ENGERIX-B™ group. The trial also recorded how many participants experienced injection-site reactions (such as redness or soreness at the needle site): 103 in the modified process vaccine group, 115 in the RECOMBIVAX-HB™ group, and 107 in the ENGERIX-B™ group. A raised temperature of 100°F (37.8°C) or above was recorded in 2 people in the modified process vaccine group, 3 in the RECOMBIVAX-HB™ group, and 3 in the ENGERIX-B™ group. The reported data shows that zero participants across all three groups experienced a serious adverse event considered to be related to the vaccine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00343915 · results posted 31 March 2009

  According to the results reported on ClinicalTrials.gov, this trial compared two different dosing schedules of a hepatitis B vaccine called Engerix. One group received 2 doses and the other received 3 doses. A total of 384 people started the main part of the trial — 258 in the 2-dose group and 126 in the 3-dose group. The trial followed participants over several years (up to around 66 months, or about five and a half years) to measure how many people maintained a level of hepatitis B antibodies considered "protective" (defined as a blood level of 10 mIU/mL or above), and to track how antibody levels changed over time. The reported data shows that after the main vaccination period, 233 out of 258 people in the 2-dose group and 111 out of 126 people in the 3-dose group reached that protective antibody level. Over the follow-up years, the number of people maintaining that level gradually declined in both groups. For example, by the final follow-up check (month 66), the reported numbers maintaining protective levels were 105 (out of 158 remaining) in the 2-dose group and 64 (out of 76 remaining) in the 3-dose group. The reported data also shows average antibody levels (a measure called geometric mean concentration) were consistently higher in the 3-dose group at every follow-up point — for instance, at month 30, the reported figures were 229.0 mIU/mL for the 2-dose group and 708.3 mIU/mL for the 3-dose group. Regarding reported local reactions at the injection site (such as pain, redness, or swelling), 121 people in the 2-dose group and 44 in the 3-dose group reported at least one such symptom; severe reactions were reported by only a small number of participants in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.