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Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148824
First Posted: September 8, 2005
Last Update Posted: March 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: March 21, 2008
Last Verified: March 2008

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs


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