HIV Infection Clinical Trial
Official title:
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
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.
Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell
count above 200/mm3
Intervention:
1. Arm A: GenHevac-B® 20μg IM at M0, M1, M6
2. Arm B: GenHevac-B® 40μg IM at M0, M1, M6
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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