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NCT04487041 | RECRUITING | Human Influenza

Tfh Dysfunction in HIV and Aging
Sponsor:

University of Miami

Information provided by (Responsible Party):

Savita Pahwa

Brief Summary:

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.

Condition or disease

Human Influenza

Intervention/treatment

Standard dose influenza vaccination

High dose influenza vaccination

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Tfh Dysfunction in HIV and Aging
Actual Study Start Date : 2020-10-30
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. For HIV positive participants
    • * HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
    • * Additional criteria for HIV positive
    • 1. on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
    • 2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
    • 3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
    • 2. For HIV negative participants
      • * Documented negative HIV test at the time of study entry, either by any licensed ELISA.
      • 3. For all participants
        • 1. Individuals age: ≤35 years and ≥65 years.
        • 2. No history of other immunodeficiency disorders
        • 3. Not on steroid or other immunosuppressive/immunomodulators medications.
        • 4. No active malignancies.
        • 5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
        • 6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
        • 7. Able to provide informed consent.
        • Exclusion criteria
        • 1. Contraindication to receive influenza vaccination.
        • 2. Non-adherence to ART for HIV positive
        • 3. Unable to provide informed consent.
        • 4. Influenza vaccination already given during the current vaccination season.
        • 5. Known drug abuse including cocaine by history
Tfh Dysfunction in HIV and Aging

Location Details

NCT04487041

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136