Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00148824
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Study Completion: 2006-01
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-20
• Last Update Posted: 2008-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Adult patients with proven HIV-1 infection
• Naïve or antiretroviral experienced
• CD4 cell count between 200 and 500/mm3
• Plasma HIV RNA load lower than 4 log10 copies/mL
• Signed written informed consent

Exclusion Criteria

• Immunotherapy
• Immunization with the PPV within the past 5 years
• Splenectomy
• Use of intravenous immunoglobulin within the past 2 months
• Chemotherapy or radiation
• Any other vaccination within the past 2 months
• Severe renal failure
• End-stage liver disease
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients responders to 7 pneumococcal polysaccharides at W8

Secondary Outcome Measures

Name	Time	Method
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