Impact of HIV-1 and Aging on Mucosal Vaccine Responses

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

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2028-01-01

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.

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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 .

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Healthy control and HIV-1-infected adults aged 21-45 and 55-75 years old. For HIV-1+ undetectable plasma HIV-1 RNA and documented PPSV23. Two-time blood draw, nasopharyngeal fluid collection, physical function test, fecal collection and questionnaire. Participants will be given PCV13.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Participants with be given a screening number and a participant number as a unique identifier that does not involve their name.

Study Groups

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HIV+

One time administration of Prevnar-13 vaccine to HIV+ participants

Group Type ACTIVE_COMPARATOR

Prevnar-13

Intervention Type BIOLOGICAL

One time administration of prevnar-13 vaccine

HIV Negative Controls

One time administration of Prevnar-13 vaccine to HIV Negative Control participants

Group Type ACTIVE_COMPARATOR

Prevnar-13

Intervention Type BIOLOGICAL

One time administration of prevnar-13 vaccine

Interventions

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Prevnar-13

One time administration of prevnar-13 vaccine

Intervention Type BIOLOGICAL

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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes