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Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00148824
First received: September 7, 2005
Last updated: March 20, 2008
Last verified: March 2008

September 7, 2005
March 20, 2008
February 2003
Not Provided
Proportion of patients responders to 7 pneumococcal polysaccharides at W8
Same as current
Complete list of historical versions of study NCT00148824 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: 7-valent pneumococcal conjugate vaccine (vaccine)
  • Biological: 23-valent pneumococcal conjugate vaccine (vaccine)
Not Provided
Rabian C, Tschöpe I, Lesprit P, Katlama C, Molina JM, Meynard JL, Delfraissy JF, Chêne G, Lévy Y; ANRS 114 Pneumovac Study Group. Cellular CD4 T cell responses to the diphtheria-derived carrier protein of conjugated pneumococcal vaccine and antibody response to pneumococcal vaccination in HIV-infected adults. Clin Infect Dis. 2010 Apr 15;50(8):1174-83. doi: 10.1086/651418.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
January 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00148824
ANRS 114 PNEUMOVAC
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Philippe Lesprit, MD Service d'Immunologie Clinique, Créteil, 94010, France
Study Director: Geneviève Chêne, MD, PhD INSERM unité 593
French National Agency for Research on AIDS and Viral Hepatitis
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP