A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

HBV003

This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

2024-09-30

2025-12-31

2026-12-31

Not yet recruiting

Early phase I

40

Inclusion Criteria: * Male or female * 18 years of age or older * Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by detection of HBsAg and/or Hepatitis B DNA (Subjects on current nucleoside therapy may have no detectable Hep B DNA) * If child bearing age, using contraception (barrier method, IUD or oral contraception) * Able to provide written informed consent * Willing and able to comply with the protocol for the duration of the study. Exclusion Criteria: * Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results for the rest of the HBV markers, indicating acute infection, * Positive for anti-delta virus, or anti-hepatitis C virus or HIV * Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater * Liver transaminases greater than 5 times the upper limit of normal * History of severe allergic reaction to hepatitis B vaccine. * Pregnancy or female of child-bearing age not using effective method of contraception. * Presence of any other organ-specific disease that in the opinion of the investigator may result in risk to the subject from involvement in the study * Current alcohol or drug abuse that in the opinion of the investigator may result in non-compliance. * Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment

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2024-04-09