Impact of HIV-1 and Aging on Mucosal Vaccine Responses

Study Overview
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Brief Summary
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The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.

Detailed Description
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After being informed about the study and potential risks, patients will be screened to determine eligibility for the study and consented. Patients who meet eligibility requirements will be immunized with PCV 20. HIV-infected adults will be tested prior to and after vaccination by blood, nasal filter paper, and stool samples to characterize mucosal and systemic antibody responses . HIV-uninfected control adults will be tested at vaccination and post vaccination to characterize mucosal and systemic antibody responses .

Official Title
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Impact of HIV-1 and Aging on Mucosal Vaccine Responses

Conditions
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HIV-1-infection, Human Immunodeficiency Virus, HIV/AIDS, HIV Infections

Intervention / Treatment
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* Biological: Prevnar-13


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans only (accessibility to non-veterans pending) Age 21-45 or 55-75 Years Old Have not received pneumococcal vaccine Prevnar PCV-13 Able to attend 2-3 study visits over 1 month HIV+: -Undetectable Viral load HIV negative controls: -no history or risks for HIV infection Exclusion Criteria: Spleen removed Chronic Kidney disease (creatinine ≥ 2.0 mg/dL) Active liver disease Currently taking: Corticosteroids (prednisone, medrol, etc), Chemotherapy, Immunosuppressive medication (cyclosporine, methotrexate, azathioprine, infliximab, adalimumab, rituximab, etanercept, etc), or illicit drugs (methamphetamine, cocaine, crack, or heroin)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV+<br>One time administration of Prevnar-13 vaccine to HIV+ participants | Biological: Prevnar-13<br>* One time administration of prevnar-13 vaccine<br>|
| Active Comparator: HIV Negative Controls<br>One time administration of Prevnar-13 vaccine to HIV Negative Control participants | Biological: Prevnar-13<br>* One time administration of prevnar-13 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid) | Determine pneumococcal specific IgG levels in BAL fluid and NPF and to standardize the results we will compare it to the total levels in the BAL/NPF fluid collected at all timepoints | A change from baseline, measured at pre-vaccination, and 1 month post vaccine | 
| Determine pneumococcal specific IgG levels in serum | Determine pneumococcal specific IgG levels in serum 1 month post vaccination response criteria must meet >2-fold rise with a post-vaccination level >1000 ng/ml for > 7 of the 12 serotypes | A change from baseline, measured at pre-vaccination, and 1 month post vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Streptococcus pneumoniae infection, Prevnar-13, PCV-13, Pneumococcal vaccine, Pneumococcal vaccines, Streptococcus pneumoniae colonization