Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148824
Status:
COMPLETED
Last Update Posted:
2008-03-21
First Post:
2005-09-07
Brief Title:
Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 500mm3 This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500mm3
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 cellsmm3 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 500mm3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None