Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost
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