In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer. However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
437
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Hopital Cochin CIC de vaccinologie
Paris, France
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.
Time frame: two months after the last injection;week 28, month 18, month 30 and month 42
According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion
Time frame: two months after the last injection; week 28, month 18, month 30 and month 42
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