Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients

Launched by ANRS, EMERGING INFECTIOUS DISEASES · May 30, 2007

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
• • Criteria
• Inclusion criteria:
• • HIV infection
• • T CD4 count cell level above 200 per mm3
• • Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
• • unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit
• • Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3
• • Pregnancy test negative at the screening and inclusion visits
• Exclusion Criteria:
• • Any injection of the vaccine against Hepatitis B in the medical history
• • Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
• • Any vaccine received one month before the inclusion
• • History of intolerance to any component of GenHevac-B
• • Evolutive opportunistic infection treated the month before the screening visit
• • Severe and acute pyretic infection or unexplained fever the week before inclusion
• • Evolutive hemopathy or solid-organ cancer
• • Prothrombin factor equal or below 50 percent 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 above 7 days) in the last 6 months before the screening visit
• • Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months
• • Splenectomy
• • Decompensated cirrhosis (Child Pugh B or C)
• • Kidney deficient function (creatinine clearance below 50 ml per mn)
• • Other 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