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
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)
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
Vaxine Pty Ltd
Lead sponsor
Australian Respiratory and Sleep Medicine Institute
Collaborator