Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.
Biological: 7-valent pneumococcal conjugate vaccine (vaccine)
Biological: 23-valent pneumococcal conjugate vaccine (vaccine)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunological Efficacy of a Prime-Boost Strategy Combining a 7-Valent Pneumococcal Conjugate Vaccine (PCV) Followed by a 23-Valent Pneumococcal Polysaccharide Vaccine (PPV) Versus PPV Alone in HIV-Infected Adults. ANRS 114 PNEUMOVAC.|
- Proportion of patients responders to 7 pneumococcal polysaccharides at W8
- Persistence of antibody responses at W24 and W96
- Clinical tolerance of pneumococcal vaccines at W8
- Evolution of the CD4 count and plasma HIV RNA load
- Immunological substudy (predictive factors of the antibody responses) at W24
|Study Start Date:||February 2003|
|Study Completion Date:||January 2006|
Streptococcus pneumoniae (SP) is the major cause of bacterial infection in HIV-infected patients. The 23-valent pneumococcal polysaccharide (PPV) is poorly immunogenic in patients with CD4 below 500 cells/mm3. The purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (PCV), able to induce immunological memory, would improve immunogenicity against SP polysaccharides. 212 HIV-1 infected patients, with a CD4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: PCV at Week 0 followed by PPV at Week 4 or PPV alone at Week 4. Evaluation will be done at week 8. The primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.
|Principal Investigator:||Philippe Lesprit, MD||Service d'Immunologie Clinique, Créteil, 94010, France|
|Study Director:||Geneviève Chêne, MD, PhD||INSERM unité 593|