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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148824
|Principal Investigator:||Philippe Lesprit, MD||Service d'Immunologie Clinique, Créteil, 94010, France|
|Study Director:||Geneviève Chêne, MD, PhD||INSERM unité 593|