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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Wyeth |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00148824 |
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 |
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HIV Infections |
Biological: 7-valent pneumococcal conjugate vaccine (vaccine) Biological: 23-valent pneumococcal conjugate vaccine (vaccine) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 212 |
Study Start Date: | February 2003 |
Study Completion Date: | January 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Philippe Lesprit, MD | Service d'Immunologie Clinique, Créteil, 94010, France |
Study Director: | Geneviève Chêne, MD, PhD | INSERM unité 593 |
Study ID Numbers: | ANRS 114 PNEUMOVAC |
Study First Received: | September 7, 2005 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00148824 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
HIV infections Pneumococcal vaccines Treatment Experienced Treatment Naive |
Virus Diseases Antibodies Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Immunoglobulins |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |