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Recruiting Phase 4 NCT04487041

Tfh Dysfunction in HIV and Aging

Trial Parameters

Condition Human Influenza
Sponsor University of Miami
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-10-30
Completion 2026-06-30
Interventions
Standard dose influenza vaccinationHigh dose influenza vaccination

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 standa

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