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DNA vaccine could help hepatitis b patients stop daily pills

NCT ID NCT00536627

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a DNA vaccine can help people with chronic hepatitis B control the virus after they stop taking standard antiviral drugs. The vaccine aims to boost the immune system to delay the virus from becoming active again. The trial involves 70 adults who have undetectable virus levels and are currently on treatment.

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 pCMVS2.S
What this could lead to
If successful, this could offer a way to control hepatitis B without lifelong medication, potentially reducing the need for daily antiviral pills.
What could go wrong
This is an early-phase trial with only 70 participants, so results may not apply widely. The vaccine may not prevent viral reactivation, and side effects are still being studied.

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

70 people

The number who actually took part.

Start date

Jan 2008

Finished

Nov 2010

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 75 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 hepatitis B with or without AgHBe * no cirrhosis and no hepatocellular carcinoma * treatment with NRTI unchanged for at least 3 months * undetectable HBV viral load for 12 months * HBV viral load \< 12 IU/ml at screening * sGPT \< 5N * tetanus immunization or booster dose for less than 8 years * accurate birth control or menopausal women or sterility * sickness insurance * signed informed consent Exclusion Criteria: * HLA-DR 15/16 * coinfections with HDV, HCV and/or HIV * treatment with immunomodulators * immunosuppressors * long-term corticotherapy (over 4 weeks) * active intravenous drug-users * prolonged and excessive consumption of alcohol (men \> 40g/day ; women \> 30g/day ; for more than 5 years) * medical history of autoimmune disease or presence of autoantibodies * previous immunization by HBV vaccine of less than 5 years * previous immunization by DNA vaccine against HBV * personal or family medical history of demyelinising diseases * uncontrolled hypophosphatemia * renal failure, renal transplantation, haemodialysis * pregnancy, breast-feeding

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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

  • FONTAINE Hélène

    Paris, France

More trials for these conditions

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