Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Healthy participants group:

• People aged 2 to 45 years old who are in good health
• People (or their parents or legal representatives) who have given their voluntary agreement to take part
• People who are willing to follow all study procedures, attend all visits for the full length of the study, and agree to provide all required samples
• People who have tested negative for HIV
• People who are not pregnant at the time of joining
• Female participants who are able to become pregnant, and males who have not had a sterilisation procedure, who agree to use effective contraception until at least 8 months after the first vaccination
• People who have used adequate contraception, or who have not had any activities that could result in pregnancy, for at least 28 days before receiving the first dose of the vaccine
• Female participants who are not currently breastfeeding

HIV-positive participants group:

• Adults aged 18 to 45 years old who are living with HIV and are currently on anti-retroviral (HIV treatment) medication, and who are willing to have their immune cell count (CD4) and virus levels measured as required by the study
• People who are able to give voluntary signed consent to participate
• People who are willing to follow all study procedures, attend all visits for the full length of the study, and agree to provide all required samples
• Female participants who are able to become pregnant, and males who have not had a sterilisation procedure, who agree to use effective contraception until at least 3 months after the last vaccination
• People who have used adequate contraception, or who have not had any activities that could result in pregnancy, for at least 28 days before receiving the last dose of the vaccine
• Female participants who are not currently breastfeeding

Who may not be able to join:

Healthy participants group:

• People who have previously received any hepatitis E vaccine
• People who have had a fever (body temperature of 38°C or higher) or any acute illness within the 3 days before their scheduled vaccination
• People with a known allergy to any ingredient in the study vaccine or related medications, or any other allergy or medical history that the study doctor believes could increase the risk of a bad reaction (for example, a history of Guillain-Barré Syndrome)
• People with major birth defects that, in the study doctor's opinion, may affect their ability to take part in the study
• People with a known history of immune system problems, including immunodeficiency diseases (such as known HIV infection or other immune disorders) or lupus
• People who have been regularly using high-dose steroid medications, chemotherapy-type drugs, or other immune-suppressing drugs in the past 6 weeks (confirm with trial site for specific dose thresholds)
• People with any ongoing health condition or abnormality that, in the study doctor's opinion, could be harmful to them or interfere with the study results
• People with behavioural, cognitive, substance use, psychiatric, or neurological conditions that, in the study doctor's opinion, could affect their ability to participate
• People who have had their spleen removed
• People with a history of low platelet counts, blood clotting problems, inflammation of the heart muscle (myocarditis), inflammation of the sac around the heart (pericarditis), or any other significant heart condition
• People with a known bleeding disorder or any condition that may cause prolonged bleeding, which could make injections or blood draws unsafe
• People who have received blood or blood-derived products in the past 3 months
• People who have received another vaccine within the 4 weeks before the study vaccine, or who are planning to receive a vaccine within 4 weeks of their last study dose
• People who are currently taking part in, or planning to join, another clinical trial at the same time
• People who are members of the research team running this study, or who live in the same household as a member of the research team
• Adults with a body mass index (BMI) of 40 or above, or children whose BMI is at or above the 95th percentile for their age, at the time of the screening visit
• People who, in the study doctor's medical judgement, should not participate even if they appear to meet all other criteria

HIV-positive participants group:

• People who have previously received any hepatitis E vaccine
• People who have been newly diagnosed with HIV (found positive during screening) and have been on anti-retroviral treatment for less than 4 weeks (note: these individuals may be re-screened and considered for enrolment once they have been on treatment for at least 4 weeks)
• People who have had a fever (body temperature of 38°C or higher) or any acute illness within the 3 days before their scheduled vaccination
• People who have had a serious reaction to any vaccine, or any component of the study vaccine, including a history of anaphylaxis, severe allergic reactions, or any history of allergies
• People who are currently hospitalised
• People with a history of inherited blood disorders, heparin-induced low platelet counts, or blood clotting disorders
• People who have received any blood product transfusion in the 6 months before enrolment
• People who have received another vaccine within the 4 weeks before the study vaccine, or who are planning to receive a vaccine within 4 weeks of their last study dose
• People who are currently taking blood-thinning medication or who have regularly taken aspirin in the past 3 months
• People who are pregnant or breastfeeding at any point during the study
• People with extreme obesity, defined as a BMI of 40 or above
• People with severe kidney disease that requires dialysis
• People with liver disease (note: mild chronic liver disease is not an exclusion criterion)
• People with immune deficiency conditions other than HIV, whether inherited or acquired
• People with a history of hereditary, unknown-cause, or acquired angioedema (a condition involving swelling under the skin)
• People who do not have a spleen, or whose spleen does not function normally
• People with a platelet disorder or other bleeding disorder that could make injections unsafe
• People who have been regularly using (for more than 14 continuous days) medications that may reduce immune response, such as high-dose systemic steroids, allergy injections, immunoglobulin, interferon, or immune-modifying drugs (note: low-dose topical, eye, inhaled, and nasal steroid preparations are permitted — confirm with trial site)
• People who, in the study doctor's judgement, have any other factors that could interfere with the trial results or pose additional risks
• People who the study doctor assesses as being unable or unwilling to follow the study requirements

Important: Always verify eligibility with the trial site directly before applying.