Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.
NCT00148824
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- 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
- 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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Descriptive Information | |||||||
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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 |
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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 | 212 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | January 2006 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |