Early Versus Delayed Pneumococcal Vaccination in HIV

Study Overview
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Brief Summary
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The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

Detailed Description
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A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.

Official Title
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A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Pneumovax
* Biological: Prevnar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive Between 18 and 65 years of age Have a CD4 cell count below 200 cells/mm3 Willing to begin/change antiretroviral therapy Willing and able to provide informed consent Exclusion Criteria: Pregnant or breastfeeding Have had previous pneumococcal vaccination Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years Have hypersensitivity to components of either vaccine Have acute feverish illness at the time of vaccination Have had splenectomy (removal of the spleen) Have received treatment with IVIG within the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumovax/immediate<br> | Biological: Pneumovax<br> <br> |
| Experimental: Pneumovax/delayed<br> | Biological: Pneumovax<br> <br> |
| Experimental: Prevnar/immediate<br> | Biological: Prevnar<br> <br> |
| Experimental: Prevnar/delayed<br> | Biological: Prevnar<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serotypes to which a response is found |  |  | 
| A response is defined as a doubling in antibody titer at 1 month compared to baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response at 6 months and one year |  |  | 
| Changes in viral load 3 months post immunization |  |  | 
| Adverse events |  |  | 
| Overall incidence of invasive pneumococcal disease |  |  | 
| Incidence of invasive pneumococcal disease between vaccines |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Infections