HIV Infections
Conditions
Keywords
Hepatitis B vaccination, GenHevac-B Pasteur, HIV Infections
Brief summary
In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer. However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.
Detailed description
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3 Intervention: 1. Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6 2. Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6 3. Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Interventions
BIOLOGICALGenHevac B Pasteur
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
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
Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both Criteria Inclusion criteria: * HIV infection * T CD4 count cell level above 200 per mm3 * Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) * unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit * Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3 * Pregnancy test negative at the screening and inclusion visits
Exclusion criteria
* Any injection of the vaccine against Hepatitis B in the medical history * Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients * Any vaccine received one month before the inclusion * History of intolerance to any component of GenHevac-B * Evolutive opportunistic infection treated the month before the screening visit * Severe and acute pyretic infection or unexplained fever the week before inclusion * Evolutive hemopathy or solid-organ cancer * Prothrombin factor equal or below 50 percent 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 above 7 days) in the last 6 months before the screening visit * Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months * Splenectomy * Decompensated cirrhosis (Child Pugh B or C) * Kidney deficient function (creatinine clearance below 50 ml per mn) * Other 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 |
|---|---|
| HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml. | two months after the last injection;week 28, month 18, month 30 and month 42 |
Secondary
| Measure | Time frame |
|---|---|
| According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion | two months after the last injection; week 28, month 18, month 30 and month 42 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOROdile Launay, MD
CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
STUDY_CHAIRFabrice Carrat, MD
Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr
Outcome results
None listed