Impact of HIV-1 and Aging on Mucosal Vaccine Responses

Early Phase 1

Active, not recruiting

• Conditions: HIV Infections; HIV-1-infection; HIV/AIDS; Human Immunodeficiency Virus
• Interventions: Biological: Prevnar-13

• Registration Number: NCT03729778
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief 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 .

Study Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV Negative Controls	Prevnar-13	One time administration of Prevnar-13 vaccine to HIV Negative Control participants
HIV+	Prevnar-13	One time administration of Prevnar-13 vaccine to HIV+ participants

Primary Outcome Measures

Name	Time	Method
Determine pneumococcal specific IgG levels in serum	A change from baseline, measured at pre-vaccination, and 1 month post vaccine	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
Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid)	A change from baseline, measured at pre-vaccination, and 1 month post vaccine	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

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center; 🇺🇸 Aurora, Colorado, United States