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RecruitingPhase 4NCT04487041

Tfh Dysfunction in HIV and Aging

Sponsor

University of Miami

Enrollment

400 participants

Start Date

Oct 30, 2020

Study Type

INTERVENTIONAL

Conditions

Human Influenza

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria16

  • 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
  • on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
  • Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
  • Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
  • For HIV negative participants:
  • Documented negative HIV test at the time of study entry, either by any licensed ELISA.
  • For all participants:
  • Individuals age: ≤35 years and ≥65 years.
  • No history of other immunodeficiency disorders
  • Not on steroid or other immunosuppressive/immunomodulators medications.
  • No active malignancies.
  • Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
  • Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
  • Able to provide informed consent.

Exclusion Criteria5

  • Contraindication to receive influenza vaccination.
  • Non-adherence to ART for HIV positive
  • Unable to provide informed consent.
  • Influenza vaccination already given during the current vaccination season.
  • Known drug abuse including cocaine by history

Interventions

BIOLOGICALStandard dose influenza vaccination

Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle

BIOLOGICALHigh dose influenza vaccination

4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle

Locations(1)

University of Miami

Miami, Florida, United States

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NCT04487041