Hepatitis B, HIV Infection
Conditions
Keywords
Hepatitis B vaccination, GenHevac-B Pasteur, HIV infection
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 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.
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
Interventions
BIOLOGICALGenHevac-B
1 intramuscular injection of Genhevac-B® 20μg on day zero, month 1,and month 6
Sponsors
ANRS, Emerging Infectious Diseases
MCM Vaccines B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | one month after the last vaccination (week 28) |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | at D0 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDavid Rey, MD
Hôpital civil, Strasbourg, France
STUDY_CHAIRFabrice Carrat, MD
Inserm U707 Paris France
Outcome results
None listed