Tfh Dysfunction in HIV and Aging

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Human Influenza

Treatments: Biological: Standard dose influenza vaccination; Biological: High dose influenza vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT04487041

20200752

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Young HIV negative group

Active Comparator group

Description:

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.

Treatment:

Biological: High dose influenza vaccination

Biological: Standard dose influenza vaccination

Young HIV positive group

Experimental group

Description:

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.

Treatment:

Biological: High dose influenza vaccination

Biological: Standard dose influenza vaccination

Old HIV negative group

Experimental group

Description:

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.

Treatment:

Biological: High dose influenza vaccination

Biological: Standard dose influenza vaccination

Old HIV positive group

Experimental group

Description:

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.

Treatment:

Biological: High dose influenza vaccination

Biological: Standard dose influenza vaccination