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

Phase 3

Completed

• Conditions: Hepatitis B; HIV Infection
• Interventions: Biological: GenHevac-B

• Registration Number: NCT00670839
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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

Study Timeline

• Study First Submitted: 2008-04-29
• Study Start: 2008-05
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2011-12
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• HIV-1 infection
• T CD4 cell count number above 200 /mm3
• History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past
• No history of Hepatitis B vaccination with a double-dose schedule
• No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit
• AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization
• unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit
• Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3
• HIV-1 plasma load below 100 000 copies per ml for patients without ARV
• Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization

Exclusion Criteria

• Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients
• Any vaccine received during the month preceding the inclusion
• History of hypersensitivity to any component of GenHevac-B
• acute opportunistic infection treated the month before the screening visit
• Severe and acute pyretic infection or unexplained fever the week before inclusion
• Hemopathy or solid-organ cancer
• Prothrombin factor equal or below 50% 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 at least 7 days) in the last 6 months before the screening visit
• Immunomodulating treatment (interferon, interleukine-2,...) in the last 6 months before the screening visit
• Splenectomy
• Decompensated cirrhosis (Child Pugh B or C)
• Renal failure (creatinine clearance below 50 ml/mn)
• Other severe 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	GenHevac-B	GenHevac-B 20 microgram intramuscular use at M0, M1 and M6
B	GenHevac-B	GenHevac-B 40 microgram intramuscular use at M0, M1 and M6

Primary Outcome Measures

Name	Time	Method
rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml	one month after the last vaccination (week 28)

Secondary Outcome Measures

Name	Time	Method
According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion	one month after the last injection ( week 28) and month 18
immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization	at D0

Trial Locations

Locations (1)

Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital; 🇫🇷 Strasbourg, France