Tfh Dysfunction in HIV and Aging

Who is this study for? Patients with Influenza
What treatments are being studied? Influenza Vaccination
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Suresh Pallikkuth, PhD
spallikkuth@med.miami.edu
3052435315
Time Frame
Start Date: 2020-10-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 400
Treatments
Active_comparator: Young HIV negative group
HIV uninfected participants that are 18-35 years of age will receive the standard dose flu vaccine. Participants who did not respond to the standard dose flu vaccination, as defined by less than a four-fold increase in flu antibody titer from baseline, will then receive the high dose flu vaccination 1 year after initial standard dose flu vaccination. Participants who respond to the standard dose flu vaccination will not receive the high dose flu vaccination.
Experimental: Young HIV positive group
HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 18-35 years of age, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Experimental: Old HIV negative group
HIV uninfected participants that are 65 years and older will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Experimental: Old HIV positive group
HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 65 years and older, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov