Tfh Dysfunction in HIV and Aging

NCT ID: NCT04487041

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2026-12-30

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.

Conditions

Human Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard dose influenza vaccination

Intervention Type: BIOLOGICAL

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

High dose influenza vaccination

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Standard dose influenza vaccination

Intervention Type: BIOLOGICAL

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

High dose influenza vaccination

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Standard dose influenza vaccination

Intervention Type: BIOLOGICAL

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

High dose influenza vaccination

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Standard dose influenza vaccination

Intervention Type: BIOLOGICAL

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

High dose influenza vaccination

Intervention Type: BIOLOGICAL

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

Interventions

Standard dose influenza vaccination

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

Intervention Type: BIOLOGICAL

High dose influenza vaccination

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone quadrivalent; Fluzone high dose quadrivalent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Savita Pahwa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Savita Pahwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suresh Pallikkuth, PhD

Role: CONTACT

spallikkuth@med.miami.edu

3052435315

Facility Contacts

Suresh Pallikkuth, PhD

Role: primary

spallikkuth@med.miami.edu

305-243-5315

Other Identifiers

20200752

Identifier Type: -

Identifier Source: org_study_id