Tests a new hepatitis B vaccine in adults with chronic hepatitis B
Tests an experimental hepatitis B vaccine in adults with long-term hepatitis B infection.
Plain-language title generated from the registry record
Registry title: A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
Key facts
- Where
- Adelaide, AustraliaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-term (chronic) hepatitis B infection. It tests a new hepatitis B vaccine as a possible treatment.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Chronic hepatitis B infection, with or without cirrhosis, shown by HBsAg and/or Hepatitis B DNA in the blood. People on nucleoside therapy may have no detectable Hep B DNA.
- Biomarker or test result
- HBsAg and/or Hepatitis B DNA detected
Main reasons for not taking part
- Acute hepatitis B infection
- Positive for anti-delta virus, hepatitis C virus or HIV
- Cirrhosis of Child grade B or greater
- Liver transaminases greater than 5 times the upper limit of normal
- Severe allergic reaction to hepatitis B vaccine in the past
Read by machine on 9 November 2026.
Where in Australia
- ARASMIAdelaide, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vaxine Pty Ltd
- Trial code
- NCT03038802
- Record updated
- 22 September 2025
- Original description
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 subjectsRead full original descriptionShow less
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
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
Inclusion: 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: 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; 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; History of severe allergic reaction to hepatitis B vaccine; 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; Liver transaminases greater than 5 times the upper limit of normal; Pregnancy or female of child-bearing age not using effective method of contraception; Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater.