NCT03729778

Impact of HIV-1 and Aging on Mucosal Vaccine Responses

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: VA Eastern Colorado Health Care System · Federal
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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

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

Interventions

Type	Name	Description
BIOLOGICAL	Prevnar-13	One time administration of prevnar-13 vaccine

Timeline

• Start date: 2017-01-18
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2018-11-05
• Last updated: 2024-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study