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New vaccine aims to train immune system against hepatitis b

NCT ID NCT06989788

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new vaccine called AVX70371, designed to treat chronic hepatitis B by training the immune system to fight the virus. It involves 16 healthy adults aged 18 to 40 to check for safety and immune responses. The study is not yet testing if it works against the disease, only if it is safe and triggers an immune reaction.

What this could mean

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

Active substance
AVX70371 (therapeutic hepatitis B vaccine)
What this could lead to
If successful, this could lead to a treatment that helps the immune system fight chronic hepatitis B, potentially reducing the need for lifelong medication.
What could go wrong
This is a very early Phase 1 trial with only 16 healthy participants, so it is primarily testing safety, not effectiveness. The vaccine may not produce a strong enough immune response or could 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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

May 2025

Expected to finish

Aug 2026

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 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 assigned at birth, inclusive of all gender identities * Between, and including, 18 and 40 years of age on the day of the Screening Visit * Healthy individual, as established by the Investigator * Able to read and understand the informed consent form, and written informed consent obtained from the participant * Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol Exclusion Criteria: * Body Mass Index \< 18.0 or \> 32.0 kg/m2 * Use of any investigational or non-registered product other than the study vaccination within 1 month preceding study entry, or concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-registered product, at any time during the study period * Administration / planned administration of any vaccine not foreseen by the study protocol within 1 month preceding the first study vaccination and up to 1 month after the last study vaccination * Presence of serologic marker of acute, chronic or past HBV infection * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months preceding first study vaccination, or planned chronic administration at any time during the study period * Administration of long-acting immune-modifying drugs within 6 months or 5 half-lives (whichever is longer) preceding first study vaccination, or planned administration at any time during the study period * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, family history or physical examination * Administration of immunoglobulins and / or any blood or blood-derived products within 3 months preceding the first study vaccination, or planned administration during the study period * History of or current autoimmune disease * Malignancies or lymphoproliferative disorders within previous 5 years * Personal or family history of thymic pathology * History of any neurological disorders or seizures * History of any reaction or hypersensitivity likely to be exacerbated by any component of the investigational vaccine * Moderate or severe acute disease in the opinion of the Investigator, and / or fever, on Day 1 * Alcohol, prescription drug, or substance (ab)use that, in the opinion of the Investigator, might interfere with the study conduct and / or participant safety * Pregnant or lactating woman * Woman of childbearing potential who is not utilizing a highly effective birth control method for at least 1 month prior to the first study vaccination, or who is planning to discontinue highly effective contraception prior to 2 months following the last study vaccination * Employed by the Sponsor, by the contract research organisations working on behalf of the Sponsor, by the Investigator or the study site, or close relatives of research staff working on this study * Medical condition or use of medication(s) that can increase the risk of bleeding or haematoma * Any other condition or finding that the Investigator judges may interfere with study procedures or study results, or renders the participant unsuitable for the study Note: other protocol-defined inclusion / exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University Hospital Ghent - Centrum voor Vaccinologie (CEVAC)

    Ghent, Belgium

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Other studies related to the condition(s) this trial covers.