HIV Infection
Conditions
Keywords
HIV, hepatitis A, vaccine, HBV and/or HCV co-infection
Brief summary
Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.
Detailed description
RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected patients. The primary objective of the study is to compare the immunogenicity (percentage of patients with anti-HAV antibodies \> 20 mUI/ml at month 7) of 2 strategies (2 doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and 500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with the 2 strategies, the durability of the seroprotection 12 months after the end of vaccination, and the safety. The PARAMATERS than may have an effect on the immune response will be evaluated. This open, prospective, study have included 99 patients, aged from 18 to 55 years old. Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O, 4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28 for immunogenicity and week 72 for long term analysis
Interventions
Sponsors
Ensemble contre le SIDA
GlaxoSmithKline
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3
Exclusion criteria
* prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time \< 50%, platelets\< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity \> 2 ULN for non co-infected patients, \> 5 ULN for co-infected patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination | during de study | percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-HAV antibodies mean geometric titers 7 months after the first vaccination | during the study | anti-HAV antibodies mean geometric titers 7 months after the first vaccination |
| durability of seroprotection 1 year after the end of vaccination | during the study | durability of seroprotection 1 year after the end of vaccination |
| safety | during the study | safety |
| predictive factors of vaccinal response | during the study | predictive factors of vaccinal response |
Countries
France
Outcome results
None listed