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Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

NCT00670839

CompletedPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: Hepatitis B, HIV Infection

Interventions: GenHevac-B, GenHevac-B

Countries: France

HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer. However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* HIV-1 infection
* T CD4 cell count number above 200 /mm3
* History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past
* No history of Hepatitis B vaccination with a double-dose schedule
* No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit
* AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization
* unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit
* Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3
* HIV-1 plasma load below 100 000 copies per ml for patients without ARV
* Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization

Exclusion Criteria:

* Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients
* Any vaccine received during the month preceding the inclusion
* History of hypersensitivity to any component of GenHevac-B
* acute opportunistic infection treated the month before the screening visit
* Severe and acute pyretic infection or unexplained fever the week before inclusion
* Hemopathy or solid-organ cancer
* Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit
* Immunomodulating treatment (interferon, interleukine-2,…) in the last 6 months before the screening visit
* Splenectomy
* Decompensated cirrhosis (Child Pugh B or C)
* Renal failure (creatinine clearance below 50 ml/mn)
* Other severe 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

Locations (1)

Strasbourg, France