Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ANRS, Emerging Infectious Diseases
With
MCM Vaccines B.V.
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)
