Phase 2 Hepatitis B Trial, Recruiting
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- People who are able to understand the trial information and are willing to sign a consent form agreeing to take part.
- People who have had a confirmed chronic Hepatitis B virus (HBV) infection for at least 6 months, with specific blood test results showing HBsAg levels between 100 and 2000 IU/mL.
- People who have been on Hepatitis B antiviral medication (called nucleos(t)ide analogs) for at least 6 months, with the virus kept to very low levels in the blood during that time.
- Men, and women who are not pregnant or breastfeeding and have a negative pregnancy test, aged between 18 and 70 years old at the time of signing the consent form.
- People who, apart from chronic Hepatitis B, are in generally good health based on medical history, physical examination, and blood test results — with certain minor, specific blood test abnormalities permitted (confirm with trial site for exact acceptable ranges).
- People whose body mass index (BMI) is between 18.5 and 32.0, and who weigh more than 50 kg at the time of screening.
- People taking ongoing or occasional medications may be considered eligible if the trial doctor determines these pose no additional safety concerns and do not suggest a worsening health condition.
Who may not be able to join:
- People with a known liver disease other than Hepatitis B.
- People with advanced liver scarring or cirrhosis, as shown by ultrasound or a special liver stiffness test.
- Women of childbearing potential who do not agree to follow the contraception requirements set out in the trial protocol.
- People with a history of liver cancer (hepatocellular carcinoma).
- People who also have Hepatitis C, HIV, or Hepatitis Delta virus infections.
- People who regularly drink more than 30 g of alcohol per day (for men) or 20 g per day (for women), or who have any known drug addiction.
- People who have donated blood or blood products (450 mL or more) within 60 days before the first trial vaccination.
- People who have received any vaccine in the 2 weeks before the first trial vaccination (or 4 weeks for live vaccines), or who plan to receive a vaccine within 3 weeks after the last trial vaccination — with exceptions for pandemic or emergency vaccines such as tetanus.
- People who have previously received an MVA-based vaccine (for example, as part of a previous study, or a monkeypox or smallpox vaccination).
- People with a known allergy to any components of the trial vaccines, including yeast, E. coli proteins or fats, duck or hen's egg white, penicillin, streptomycin, or kanamycin, or who have had a life-threatening reaction to a vaccine in the past.
- People with a known history of severe allergic reaction (anaphylaxis) to any vaccine, or any allergy likely to be made worse by components of the trial vaccines.
- People with clinically relevant findings on a heart trace (ECG) or a significant history of blood clots.
- People with any medical condition that might affect their safety or the way the vaccine behaves in the body.
- People who have received immunoglobulins or blood products within the 3 months before the first trial vaccination.
- People with any confirmed or suspected immune system disorder, or who have had cytotoxic (cell-killing) therapy within the past 3 years.
- People who have taken medications that suppress or alter the immune system — such as systemic steroids, biologics, or methotrexate — within the past 3 years, with limited exceptions for topical steroids or emergency medical use.
- People with any chronic or active neurological condition, including migraine, seizures, or epilepsy — with exceptions for childhood febrile seizures and occasional headaches.
- People who have taken part in another clinical trial within the past 4 weeks (or longer, depending on the previous trial medication).
- Trial investigators, study site employees directly involved in the trial, or their immediate family members.
- People who are known or suspected to be unlikely to follow the trial requirements, or who may not be able to fully understand the information and risks involved in taking part.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Michael Hoelscher, Prof. Dr. med., Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Phone: +49-89-4400598
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Frequencies and magnitudes of unsolicited adverse events; Frequencies and magnitudes of serious adverse events (SAEs) throughout the trial period; Frequencies and magnitudes of adverse event of special interest (AESI) and Suspected Unexpected Serious Adverse Reaction (SUSAR) throughout the trial period; Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination; Frequencies and magnitudes of solicited systemic reactogenicity signs and symptoms within 7 days after each vaccination; Frequencies and magnitudes of liver toxicity (ALT flare-...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.