Clinical trial NCT00148824: Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV infections
Pneumococcal vaccines
Treatment Experienced
Treatment Naive
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients responders to 7 pneumococcal polysaccharides at W8
Secondary outcomes:
measure: Persistence of antibody responses at W24 and W96
measure: Clinical tolerance of pneumococcal vaccines at W8
measure: Evolution of the CD4 count and plasma HIV RNA load
measure: Immunological substudy (predictive factors of the antibody responses) at W24
Other outcomes:
Locations:
Study officials:
affiliation: Service d'Immunologie Clinique, Créteil, 94010, France
name: Philippe Lesprit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM unité 593
name: Geneviève Chêne, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Rabian C, Tschope I, Lesprit P, Katlama C, Molina JM, Meynard JL, Delfraissy JF, Chene G, Levy 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.