Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Immediate

Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment.

PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Group Type OTHER

(PV) 23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Currently commercially available pneumococcal polysaccharide vaccine

Placebo

Intervention Type BIOLOGICAL

Placebo

Delayed

Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment.

PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Group Type OTHER

(PV) 23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Currently commercially available pneumococcal polysaccharide vaccine

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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(PV) 23-valent pneumococcal polysaccharide vaccine

Currently commercially available pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Other Intervention Names

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Pneumovax 23

Eligibility Criteria

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Inclusion Criteria

* HIV infected
* CD4 count \>200
* no acute illness
* no pneumococcal vaccination within 3 years
* naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
* willingness to start antiretroviral treatment as recommended by current guidelines