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Impact of HIV-1 and Aging on Mucosal Vaccine Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Human Immunodeficiency Virus HIV/AIDS HIV Infections Biological: Prevnar-13 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV+
One time administration of Prevnar-13 vaccine to HIV+ participants
 Biological: Prevnar-13
One time administration of prevnar-13 vaccine
Active Comparator: HIV Negative Controls
One time administration of Prevnar-13 vaccine to HIV Negative Control participants
 Biological: Prevnar-13
One time administration of prevnar-13 vaccine


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729778


Contacts
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Contact: Mandy N Borgeson 720-788-8318 mandy.borgeson@cuanschutz.edu
Contact: Jeremy Rahkola 3037243020 Jeremy.Rahkola@cuanschutz.edu

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Mandy N Borgeson    720-788-8318    mandy.borgeson@ucdenver.edu   
Principal Investigator: Edward N Janoff, MD         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
More Information
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Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT03729778    
Other Study ID Numbers: 16-1919
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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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
Keywords provided by VA Eastern Colorado Health Care System:
HIV
Streptococcus pneumoniae infection
Prevnar-13
PCV-13
 Pneumococcal vaccine
Pneumococcal vaccines
Streptococcus pneumoniae colonization
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs