NCT03038802Not yet recruitingPhase 1/2
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 30 Jan 2017
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Vaxine Pty Ltd
- Diseases
- Hepatitis B
- NCT number
- NCT03038802
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Liver transaminases greater than 5 times the upper limit of normal
Age
- Pregnancy or female of child-bearing age not using effective method of contraception.
Other
- Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ARASMI Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.