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)
ClinicalTrials.gov Identifier:
NCT00670839
First Posted: May 2, 2008
Last Update Posted: August 12, 2013
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)
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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: None (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
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | April 29, 2008 |
| First Posted: | May 2, 2008 |
| Last Update Posted: | August 12, 2013 |
| Last Verified: | August 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 |