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

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00670839
First received: April 29, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis B
HIV Infection
Biological: GenHevac-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 [ Time Frame: one month after the last vaccination (week 28) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: one month after the last injection ( week 28) and month 18 ] [ Designated as safety issue: Yes ]
  • immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization [ Time Frame: at D0 ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: May 2008
Study Completion Date: February 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
GenHevac-B 20 microgram intramuscular use at M0, M1 and M6
Biological: GenHevac-B
1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6
Other Name: Sanofi Pasteur MSD
Experimental: B
GenHevac-B 40 microgram intramuscular use at M0, M1 and M6
Biological: GenHevac-B
2 intramuscular injections of Genhevac-B® 20μg on day zero, month 1,and month 6
Other Name: Sanofi Pasteur MSD

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670839

Locations
France
Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital
Strasbourg, France, 67091 Cedex
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sanofi Pasteur MSD
Investigators
Principal Investigator: David Rey, MD Hôpital civil, Strasbourg, France
Study Chair: Fabrice Carrat, MD Inserm U707 Paris France
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT00670839     History of Changes
Other Study ID Numbers: 2007-005023-15, ANRS HB04 B-BOOST
Study First Received: April 29, 2008
Last Updated: August 8, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Hepatitis B vaccination
GenHevac-B Pasteur
HIV infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Infection
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014