Open-Label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-Infected Patients With CD4-Positive T-Lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T
CD4 above 200 per mm3
Intervention:
1. Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
2. Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
3. Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
two months after the last injection;week 28, month 18, month 30 and month 42
Yes
Odile Launay, MD
Principal Investigator
CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2006-003940-50
NCT00480792
June 2007
December 2008
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