Clinical trial NCT04487041: Tfh Dysfunction in HIV and Aging
Official title: Tfh Dysfunction in HIV and Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Influenza
Keywords: HIV
Aging
flu vaccination
high dose vaccination
immune function
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in HAI antibody response
timeFrame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
measure: Change in neutralization antibody response
timeFrame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
measure: Percentage of Participants with Vaccine Response
timeFrame: Month 13 (1 month post high-dose flu vaccination)
Secondary outcomes:
measure: Percentage of T-follicular helper (Tfh) cells
timeFrame: Month 13 (1 month post high-dose flu vaccination)
measure: Percentage of B cells
timeFrame: Month 13 (1 month post high-dose flu vaccination)
measure: Percentage of monocytes
timeFrame: Month 13 (1 month post high-dose flu vaccination)
measure: Percentage of Tfh cells producing cytokines
timeFrame: Month 13 (1 month post high-dose flu vaccination)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Savita Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
References: