NCT00148824

Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (planned)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	7-valent pneumococcal conjugate vaccine (vaccine)
BIOLOGICAL	23-valent pneumococcal conjugate vaccine (vaccine)

Timeline

• Start date: 2003-02-01
• Completion: 2006-01-01
• First posted: 2005-09-08
• Last updated: 2008-03-21