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Impact of HIV-1 and Aging on Mucosal Vaccine Responses

Primary Purpose

HIV-1-infection, Human Immunodeficiency Virus, HIV/AIDS

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prevnar-13
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV-1-infection focused on measuring HIV, Streptococcus pneumoniae infection, Prevnar-13, PCV-13, Pneumococcal vaccine, Pneumococcal vaccines, Streptococcus pneumoniae colonization

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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)
  • Lymphoma or leukemia
  • 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)

Sites / Locations

  • Rocky Mountain Regional VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HIV+

HIV Negative Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2018
Last Updated
March 14, 2023
Sponsor
VA Eastern Colorado Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03729778
Brief Title
Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Official Title
Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Eastern Colorado Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection, Human Immunodeficiency Virus, HIV/AIDS, HIV Infections
Keywords
HIV, Streptococcus pneumoniae infection, Prevnar-13, PCV-13, Pneumococcal vaccine, Pneumococcal vaccines, Streptococcus pneumoniae colonization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV+
Arm Type
Active Comparator
Arm Description
One time administration of Prevnar-13 vaccine to HIV+ participants
Arm Title
HIV Negative Controls
Arm Type
Active Comparator
Arm Description
One time administration of Prevnar-13 vaccine to HIV Negative Control participants
Intervention Type
Biological
Intervention Name(s)
Prevnar-13
Intervention Description
One time administration of prevnar-13 vaccine
Primary Outcome Measure Information:
Title
Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid)
Description
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
Time Frame
A change from baseline, measured at pre-vaccination, and 1 month post vaccine
Title
Determine pneumococcal specific IgG levels in serum
Description
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
Time Frame
A change from baseline, measured at pre-vaccination, and 1 month post vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly M Wills, BSN
Phone
720-654-9216
Email
kelly.wills1@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Rahkola
Phone
3037243020
Email
Jeremy.Rahkola@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward N Janoff, MD
Organizational Affiliation
University of Colorado Anschutz; Rocky Mountain Regional VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly M Wills, BSN
Phone
720-654-9216
Email
kelly.wills1@va.gov
First Name & Middle Initial & Last Name & Degree
Edward N Janoff, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15995950
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. J Infect Dis. 2005 Aug 1;192(3):377-86. doi: 10.1086/431521. Epub 2005 Jun 23.
Results Reference
result
PubMed Identifier
21150868
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 the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010 Dec 10;59(RR-11):1-18.
Results Reference
result
PubMed Identifier
22048728
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):1477-81.
Results Reference
result
PubMed Identifier
25785969
Citation
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, Lobatto R, Oosterman B, Visser N, Caspers E, Smorenburg A, Emini EA, Gruber WC, Grobbee DE. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015 Mar 19;372(12):1114-25. doi: 10.1056/NEJMoa1408544.
Results Reference
result

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Impact of HIV-1 and Aging on Mucosal Vaccine Responses

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