Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

Study Overview
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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.

Official Title
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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.

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: 7-valent pneumococcal conjugate vaccine (vaccine)
* Biological: 23-valent pneumococcal conjugate vaccine (vaccine)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 7-valent pneumococcal conjugate vaccine (vaccine)|nan|
|Biological: 23-valent pneumococcal conjugate vaccine (vaccine)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responders to 7 pneumococcal polysaccharides at W8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of antibody responses at W24 and W96 |  |  | 
| Clinical tolerance of pneumococcal vaccines at W8 |  |  | 
| Evolution of the CD4 count and plasma HIV RNA load |  |  | 
| Immunological substudy (predictive factors of the antibody responses) at W24 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infections, Pneumococcal vaccines, Treatment Experienced, Treatment Naive