Double-Dose vaccine may protect HIV patients from hepatitis b

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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