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Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST) (B-BOOST)
This study has been completed.
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
MCM Vaccines B.V.
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
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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 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) ]
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 ]
- immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization [ Time Frame: at D0 ]
| 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:
- Arm A: GenHevac-B® 20μg IM at M0, M1, M6
- Arm B: GenHevac-B® 40μg IM at M0, M1, M6
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00670839
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)
MCM Vaccines B.V.
Investigators
| Principal Investigator: | David Rey, MD | Hôpital civil, Strasbourg, France |
| Study Chair: | Fabrice Carrat, MD | Inserm U707 Paris France |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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:
|
Hepatitis Hepatitis A HIV Infections 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 Hepadnaviridae Infections DNA Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 28, 2017