DNA vaccine could help hepatitis b patients stop daily pills
NCT ID NCT00536627
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 Hide 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
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Other studies related to the condition(s) this trial covers.
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