Status:
COMPLETED
Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
MCM Vaccines B.V.
Conditions:
Hepatitis B
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sta...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00670839
Start Date
May 1 2008
End Date
February 1 2013
Last Update
August 12 2013
Active Locations (1)
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1
Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital
Strasbourg, France, 67091 Cedex