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NCT03729778 Clinical Trial

Impact of HIV-1 and Aging on Mucosal Vaccine Responses

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03729778
Other study ID # 16-1919
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 18, 2017
Est. completion date January 1, 2025

Study information
Verified date March 2023
Source VA Eastern Colorado Health Care System
Contact Kelly M Wills, BSN
Phone 720-654-9216
Email kelly.wills1@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Prevnar-13
One time administration of prevnar-13 vaccine

Locations
Country Name City State
United States Rocky Mountain Regional VA Medical Center Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bonten MJ, Huijts SM, Bolkenbaas M, Webber C, Patterson S, Gault S, van Werkhoven CH, van Deursen AM, Sanders EA, Verheij TJ, Patton M, McDonough A, Moradoghli-Haftvani A, Smith H, Mellelieu T, Pride MW, Crowther G, Schmoele-Thoma B, Scott DA, Jansen KU, — View Citation

Centers for Disease Control and Prevention (CDC). Invasive pneumococcal disease and 13-valent pneumococcal conjugate vaccine (PCV13) coverage among children aged </=59 months---selected U.S. regions, 2010--2011. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43 — View Citation

Kyaw MH, Rose CE Jr, Fry AM, Singleton JA, Moore Z, Zell ER, Whitney CG; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. The influence of chronic illnesses on the incidence of invasive pneumococcal disease in adults. — View Citation

Nuorti JP, Whitney CG; Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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