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Could a vaccine tame chronic hepatitis b?

NCT ID NCT05841095

Disease control Sponsor: Erasmus Medical Center 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This early-stage trial tests a therapeutic vaccine called ISA104 in 24 people with chronic hepatitis B who are already on antiviral drugs. The goal is to see if the vaccine is safe and can boost the immune system to better fight the virus. Participants will receive either ISA104 or a placebo, and researchers will monitor side effects and immune responses.

What this could mean

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

Active substance
ISA104 (therapeutic hepatitis B virus synthetic long peptide vaccine)
What this could lead to
If successful, ISA104 could help control chronic hepatitis B by boosting the immune system, potentially reducing the need for lifelong antiviral medication.
What could go wrong
This is an early-phase trial with only 24 participants, so results may not apply widely. The vaccine may not trigger 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 1/2

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

Participants

About 24 people

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

Started

Aug 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 55 years

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: * cHBV * Active treatment with NUCs and HBV DNA \< limit of quantification Exclusion Criteria: * Immune-compromised * Evidence of liver cirrhosis

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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

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, Netherlands

More trials for these conditions

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