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DNA vaccine trial aims to wake up immune system against hepatitis b

NCT ID NCT00988767

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a DNA vaccine in 10 adults with chronic hepatitis B who had not responded to standard treatments. The vaccine was designed to train the immune system to fight the virus. The main goal was to check safety, with a secondary goal of seeing if the vaccine could restore 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
DNA vaccine (pCMV-S2.S DNA)
What this could lead to
If successful, this approach could help control chronic hepatitis B by boosting the immune system, potentially reducing the need for lifelong medication.
What could go wrong
This is a very early phase 1 trial with only 10 participants, so it is primarily testing safety. The vaccine may not produce strong enough immune responses to control the virus.

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

10 people

The number who actually took part.

Start date

Feb 2001

Finished

Oct 2004

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 60 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: * chronic HBV carriers * biopsy proven chronic hepatitis * active HBV replication for \> 6 months * non responding to Interferon-alpha or lamivudine treatment Exclusion Criteria: * co-infection with HIV, HCV, delta hepatitis virus * alcohol consumption\> 40g/day * decompensated liver disease * HLA DR2

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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

  • Service d'Hepatologie, Hopital Necker Enfants Malades

    Paris, 75015, France

More trials for these conditions

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