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OpenTrials
Active, Not Recruiting

NCT Number: NCT04487041

Tfh Dysfunction in HIV and Aging

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Standard dose influenza vaccination

Biological

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

Other names: Fluzone quadrivalent

High dose influenza vaccination

Biological

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

Other names: Fluzone high dose quadrivalent

Primary outcomes

  1. Change in HAI antibody response

    Time frame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)

    Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.

  2. Change in neutralization antibody response

    Time frame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)

    Change in mean titers of neutralization antibody response will be measured using serum sample.

  3. Percentage of Participants with Vaccine Response

    Time frame: Month 13 (1 month post high-dose flu vaccination)

    Percentage of participants that are vaccine responders and non-responders will be reported. Response is evaluated using seroconversion to the flu vaccine using serum sample.

Secondary outcomes

  1. Percentage of T-follicular helper (Tfh) cells

    Time frame: Month 13 (1 month post high-dose flu vaccination)

    Percentage of Tfh cells as measured using peripheral blood samples

  2. Percentage of B cells

    Time frame: Month 13 (1 month post high-dose flu vaccination)

    Percentage of B cells as measured using peripheral blood samples

  3. Percentage of monocytes

    Time frame: Month 13 (1 month post high-dose flu vaccination)

    Percentage of monocytes as measured using peripheral blood samples

  4. Percentage of Tfh cells producing cytokines

    Time frame: Month 13 (1 month post high-dose flu vaccination)

    Percentage of Tfh cells producing cytokines as measured using peripheral blood samples

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2020
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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