Tfh Dysfunction in HIV and Aging

Human Influenza Clinical Trial

Official title:

Tfh Dysfunction in HIV and Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487041
• Other study ID #: 20200752
• Status: Recruiting
• Phase: Phase 4
• Start date: October 30, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Suresh Pallikkuth, PhD
• Phone: 3052435315
• Email: spallikkuth[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Influenza
• Influenza, Human

Intervention

Biological:
• Standard dose influenza vaccination
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
• High dose influenza vaccination
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HAI antibody response	Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.	Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Primary	Change in neutralization antibody response	Change in mean titers of neutralization antibody response will be measured using serum sample.	Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Primary	Percentage of Participants with Vaccine Response	Percentage of participants that are vaccine responders and non-responders will be reported. Response is evaluated using seroconversion to the flu vaccine using serum sample.	Month 13 (1 month post high-dose flu vaccination)
Secondary	Percentage of T-follicular helper (Tfh) cells	Percentage of Tfh cells as measured using peripheral blood samples	Month 13 (1 month post high-dose flu vaccination)
Secondary	Percentage of B cells	Percentage of B cells as measured using peripheral blood samples	Month 13 (1 month post high-dose flu vaccination)
Secondary	Percentage of monocytes	Percentage of monocytes as measured using peripheral blood samples	Month 13 (1 month post high-dose flu vaccination)
Secondary	Percentage of Tfh cells producing cytokines	Percentage of Tfh cells producing cytokines as measured using peripheral blood samples	Month 13 (1 month post high-dose flu vaccination)