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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Biological: 7-valent pneumococcal conjugate vaccine (vaccine)
Biological: 23-valent pneumococcal conjugate vaccine (vaccine)
 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Proportion of patients responders to 7 pneumococcal polysaccharides at W8

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 212
Study Start Date: February 2003
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148824

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Philippe Lesprit, MD Service d'Immunologie Clinique, Créteil, 94010, France
Study Director: Geneviève Chêne, MD, PhD INSERM unité 593
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00148824     History of Changes
Other Study ID Numbers: ANRS 114 PNEUMOVAC
Study First Received: September 7, 2005
Last Updated: March 20, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
Pneumococcal vaccines
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013