Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV infections Pneumococcal vaccines Treatment Experienced Treatment Naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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7-valent pneumococcal conjugate vaccine (vaccine)

Intervention Type BIOLOGICAL

23-valent pneumococcal conjugate vaccine (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Philippe Lesprit, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'Immunologie Clinique, Créteil, 94010, France

Geneviève Chêne, MD, PhD

Role: STUDY_DIRECTOR

INSERM unité 593

References

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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.

Reference Type DERIVED

PMID: 20210645 (View on PubMed)

Other Identifiers

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ANRS 114 PNEUMOVAC

Identifier Type: -

Identifier Source: org_study_id