Impact of HIV-1 and Aging on Mucosal Vaccine Responses

VA Eastern Colorado Health Care System

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Human Immunodeficiency Virus; HIV-1-infection; HIV Infections; HIV/AIDS

Treatments: Biological: Prevnar-13

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03729778

16-1919

Details and patient eligibility

About

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.

Full description

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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

HIV+

Active Comparator group

Description:

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

Treatment:

Biological: Prevnar-13

HIV Negative Controls

Active Comparator group

Description:

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

Treatment:

Biological: Prevnar-13