Phase 1 Hepatitis B Trial, Recruiting

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

Who might be able to join this trial:

• People aged between 18 and 55 years old (inclusive)
• People with a body mass index (BMI) between 18.0 and 32.0 (a measure of body weight relative to height)
• People who a doctor has assessed to be in good general health, based on medical history, physical checks, heart tracing, and blood tests
• Women who cannot become pregnant — including those who have had their uterus removed, both ovaries removed, or have gone through menopause (confirmed by at least 12 months without a period and a specific hormone level on a blood test)
• Women who are able to become pregnant, provided they have used highly effective contraception for 28 days before the first injection, have a negative pregnancy test at the start of the trial, agree not to donate eggs from screening until 48 weeks after the last injection, and commit to continuing highly effective contraception or abstinence throughout that period
• Male participants who have had both testicles surgically removed, or who agree to abstain from penile-vaginal intercourse or use condoms from the start of the trial until 48 weeks after the last injection, agree not to donate sperm during that time, and whose female partners who can become pregnant also use highly effective contraception plus male condom use for the same period
• People who are willing to follow the study requirements and sign a written consent form

Who may not be able to join:

• People with a history of Hepatitis B virus (HBV) infection, shown by certain markers detected in blood tests
• People with laboratory-confirmed active infection with HIV, Hepatitis C, Hepatitis A, Hepatitis D, syphilis, or any other ongoing viral infection
• People who have had a known exposure to Hepatitis B (such as through sexual contact or blood contact) within the past 6 weeks
• People who have never previously received a Hepatitis B vaccine in the community; or who have been vaccinated but whose protective antibody level is too low on blood testing at screening; or who received a Hepatitis B vaccine within 6 months before screening; or who have a Hepatitis B vaccination planned within 48 weeks after the final study dose
• People who have taken part in another clinical trial of an investigational drug, vaccine, or medical device within the past 3 months (or within 5 half-lives of the drug, whichever is longer)
• People with certain liver enzyme or bilirubin blood test results that are 1.5 times or more above the normal upper limit, or other blood test results the doctor considers significantly abnormal
• People with a current or past history of any significant medical illness the investigator considers a concern, including (but not limited to) neurological, heart, liver, kidney, digestive, respiratory, metabolic, or bone and joint conditions
• People with a history of cancer within the past 3 years (though certain fully cured skin cancers or cervical pre-cancer may be considered — confirm with trial site)
• People with any condition linked to a weakened immune system, including diabetes
• People who have had a serious injury or major surgery within the past 3 months, or who plan to have surgery during the study
• People who have received, in the past 3 months (or 5 half-lives, whichever is longer), medications that affect the immune system — such as allergy injections, immune globulin, interferon, immunomodulating drugs, chemotherapy, or oral/injectable steroid medications (inhaled, topical, and intranasal steroids are generally allowed — confirm with trial site)
• People who have used prescription medications or vaccines within 14 days (or 5 half-lives, whichever is longer) before the first study dose
• People who have used non-prescription medications or herbal supplements (other than standard vitamins) within 7 days before the first study dose, unless the investigator and sponsor determine these are unlikely to affect the study (paracetamol and ibuprofen for pain or headaches may be accepted — confirm with trial site)
• People who smoke 10 or more cigarettes per day within 3 months before screening, or who are unable to stop using tobacco products from screening through 24 weeks after the final injection
• People with a history or evidence of alcohol misuse in the 3 months before screening, or who are unwilling to avoid alcohol for 3 weeks after the final study dose (alcohol misuse is defined as more than 14 units per week for men or 10 units per week for women — one unit being a small glass of wine, a measure of spirits, or half a pint of beer)
• People with a history or evidence of drug misuse in the 12 months before screening
• People who test positive for drugs of abuse or alcohol at screening
• People with a history of serious reactions to injections or vaccines, such as severe allergic reactions, breathing difficulties, significant swelling, or skin breakdown at an injection site
• People who have donated more than 400 mL of blood within 30 days before the first study dose
• People who the investigator considers unsuitable for any other reason

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