NCT00480792

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	GenHevac B Pasteur	Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
BIOLOGICAL	GenHevac B Pasteur	Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
BIOLOGICAL	GenHevac B Pasteur	GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-12-01
• Completion: 2012-09-01
• First posted: 2007-05-31
• Last updated: 2026-04-06

Locations

1 site across 1 country: France