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
• Status: Recruiting
• Phase: Phase 4
• 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
• 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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV-1-infection
• HIV/AIDS
• Human Immunodeficiency Virus
• Infections

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