Therapeutic hepatitis B vaccineCommercial Hepatitis B vaccine
Therapeutic hepatitis B vaccine: HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant
Commercial Hepatitis B vaccine: Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Safety assessment: Frequency of vaccine-related adverse events relative to active comparator vaccine — 12 months post immunisation Frequency of vaccine-related adverse events relative to active comparator vaccine
Viral load — 1 and 12 months post final immunisation Suppression of HBV viral load
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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