NCT00670839

Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Hepatitis B
• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	GenHevac-B	1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6
BIOLOGICAL	GenHevac-B	2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-12-01
• Completion: 2013-02-01
• First posted: 2008-05-02
• Last updated: 2026-04-07

Locations

1 site across 1 country: France