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Impact of HIV-1 and Aging on Mucosal Vaccine Responses

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ClinicalTrials.gov Identifier: NCT03729778
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE November 5, 2018
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE January 18, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid) [ Time Frame: 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
  • Determine pneumococcal specific IgG levels in serum [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Official Title  ICMJE Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Brief Summary The purpose of this study is to learn more about both HIV-1 infection and advancing age, alone and in combination, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • HIV-1-infection
  • Human Immunodeficiency Virus
  • HIV/AIDS
  • HIV Infections
Intervention  ICMJE Biological: Prevnar-13
One time administration of prevnar-13 vaccine
Study Arms  ICMJE
  • Active Comparator: HIV+
    One time administration of Prevnar-13 vaccine to HIV+ participants
    Intervention: Biological: Prevnar-13
  • Active Comparator: HIV Negative Controls
    One time administration of Prevnar-13 vaccine to HIV Negative Control participants
    Intervention: Biological: Prevnar-13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mandy N Borgeson 720-788-8318 mandy.borgeson@cuanschutz.edu
Contact: Jeremy Rahkola 3037243020 Jeremy.Rahkola@cuanschutz.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729778
Other Study ID Numbers  ICMJE 16-1919
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Eastern Colorado Health Care System
Study Sponsor  ICMJE VA Eastern Colorado Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VA Eastern Colorado Health Care System
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP