HIV patients get new hope against hepatitis b with tailored vaccine strategy
NCT ID NCT00480792
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested three different ways of giving the hepatitis B vaccine to 437 people with HIV whose CD4 counts were above 200. The goal was to see which schedule—standard dose, double dose, or skin injections—works best to protect them from hepatitis B, a virus that can cause serious liver damage in HIV patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GenHevac B Pasteur (hepatitis B vaccine)
- What this could lead to
- If successful, this could identify a more effective hepatitis B vaccination schedule for people with HIV, reducing their risk of severe liver disease.
- What could go wrong
- This trial is completed, so results are available. However, the vaccine may still be less effective in some HIV patients, and protection may not last long-term.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
437 people
The number who actually took part.
- Start date
-
Jun 2007
- Finished
-
Sep 2012
- 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 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both Criteria Inclusion criteria: * HIV infection * T CD4 count cell level above 200 per mm3 * Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) * unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit * Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3 * Pregnancy test negative at the screening and inclusion visits Exclusion Criteria: * Any injection of the vaccine against Hepatitis B in the medical history * Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients * Any vaccine received one month before the inclusion * History of intolerance to any component of GenHevac-B * Evolutive opportunistic infection treated the month before the screening visit * Severe and acute pyretic infection or unexplained fever the week before inclusion * Evolutive hemopathy or solid-organ cancer * Prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3 * Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit * Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months * Splenectomy * Decompensated cirrhosis (Child Pugh B or C) * Kidney deficient function (creatinine clearance below 50 ml per mn) * Other immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months) * Any participation to another clinical trial plan until Week 28
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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
-
Hopital Cochin CIC de vaccinologie
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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