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
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.