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

NCT ID: NCT00670839

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-02-28

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

Conditions

Hepatitis B; HIV Infection

Keywords

Hepatitis B vaccination; GenHevac-B Pasteur; HIV infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

GenHevac-B 20 microgram intramuscular use at M0, M1 and M6

Group Type: ACTIVE_COMPARATOR

GenHevac-B

Intervention Type: BIOLOGICAL

1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6

B

GenHevac-B 40 microgram intramuscular use at M0, M1 and M6

Group Type: EXPERIMENTAL

GenHevac-B

Intervention Type: BIOLOGICAL

2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6

Interventions

GenHevac-B

1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6

Intervention Type: BIOLOGICAL

GenHevac-B

2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

Sanofi Pasteur MSD; Sanofi Pasteur MSD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rey, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital civil, Strasbourg, France

Fabrice Carrat, MD

Role: STUDY_CHAIR

Inserm U707 Paris France

Locations

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

Strasbourg, , France

Countries

France

References

Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.

Reference Type: DERIVED

PMID: 26257021 (View on PubMed)

Related Links

http://www.anrs.fr

Related Info

Other Identifiers

ANRS HB04 B-BOOST

Identifier Type: -

Identifier Source: secondary_id

2007-005023-15

Identifier Type: -

Identifier Source: org_study_id