Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

INTERVENTION: Trade Name: Fendrix Pharmaceutical Form: Injection* Trade Name: Fendrix Pharmaceutical Form: Injection* CONDITION: We want to study the efficacy of Fendrix, a new adjuvant hepatitis B vaccin, in HIV infected patients, who failed to respond on intial standard and subsequent booster Hepatitis b vaccinations. We want to compare the efficacy of Fendrix to the efficacy of a double dose of the standard hepatitis b vaccinations, Engerix ; MedDRA version: 12.1 Level: LLT Classification code 10002725 Term: Anti‐HIV positive PRIMARY OUTCOME: Main Objective: We aim to study the effectiveness of this new vaccine, Fendrix®, in comparison to the regular vaccine Engerix®, in HIV‐infected non‐reponders to HBV primary vaccination schedule and non‐responders to a subsequent double dose revaccination scheme.; The primary endpoint is protective levels of anti‐HBs (>10 IU) at week 28 Primary end point(s): Primary endpoint; Protective levels of anti‐HBs (? 10 IU) at week 28; Secondary Objective: The pattarn of anti‐HBs respnise INCLUSION CRITERIA: Eligible patients must be on HAART, with HIV‐RNA < 200 copies/ml and CD4+‐cell counts > 200/ml and negative HBsAg, anti‐HBc and anti‐HBs titers. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range