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New vaccine aims to control or cure chronic hepatitis b

NCT ID NCT03038802

Disease control Sponsor: Vaxine Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tests a new therapeutic vaccine (Hepadvax) in 40 adults with chronic hepatitis B. The vaccine is designed to boost the immune system to control or possibly clear the virus. Researchers will monitor safety, viral load, and immune responses compared to a standard hepatitis B vaccine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Therapeutic hepatitis B vaccine (Hepadvax) with Advax-2 adjuvant
What this could lead to
If successful, this vaccine could help control or even clear chronic hepatitis B infection, reducing the need for lifelong antiviral medication.
What could go wrong
This is an early phase 1/2 trial with only 40 participants, so results may not apply broadly. The vaccine may not effectively reduce viral load or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ARASMI

    Adelaide, South Australia, 5046, Australia

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