Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

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NCT00148824

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Biological: 7-valent pneumococcal conjugate vaccine (vaccine)
  • Biological: 23-valent pneumococcal conjugate vaccine (vaccine)
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 7, 2005)		212
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00148824
Other Study ID Numbers  ICMJE ANRS 114 PNEUMOVAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Philippe Lesprit, MDService d'Immunologie Clinique, Créteil, 94010, France
Study Director:Geneviève Chêne, MD, PhDINSERM unité 593
PRS Account French National Agency for Research on AIDS and Viral Hepatitis
Verification Date March 2008

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