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Tfh Dysfunction in HIV and Aging

Primary Purpose

Human Influenza

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard dose influenza vaccination
High dose influenza vaccination
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Human Influenza focused on measuring HIV, Aging, flu vaccination, high dose vaccination, immune function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Young HIV negative group

Young HIV positive group

Old HIV negative group

Old HIV positive group

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in HAI antibody response
Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.
Change in neutralization antibody response
Change in mean titers of neutralization antibody response will be measured using serum sample.
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.

Secondary Outcome Measures

Percentage of T-follicular helper (Tfh) cells
Percentage of Tfh cells as measured using peripheral blood samples
Percentage of B cells
Percentage of B cells as measured using peripheral blood samples
Percentage of monocytes
Percentage of monocytes as measured using peripheral blood samples
Percentage of Tfh cells producing cytokines
Percentage of Tfh cells producing cytokines as measured using peripheral blood samples

Full Information

First Posted
July 22, 2020
Last Updated
September 22, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04487041
Brief Title
Tfh Dysfunction in HIV and Aging
Official Title
Tfh Dysfunction in HIV and Aging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Influenza
Keywords
HIV, Aging, flu vaccination, high dose vaccination, immune function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young HIV negative group
Arm Type
Active Comparator
Arm 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.
Arm Title
Young HIV positive group
Arm Type
Experimental
Arm 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.
Arm Title
Old HIV negative group
Arm Type
Experimental
Arm 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.
Arm Title
Old HIV positive group
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Standard dose influenza vaccination
Other Intervention Name(s)
Fluzone quadrivalent
Intervention Description
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
Intervention Type
Biological
Intervention Name(s)
High dose influenza vaccination
Other Intervention Name(s)
Fluzone high dose quadrivalent
Intervention Description
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle
Primary Outcome Measure Information:
Title
Change in HAI antibody response
Description
Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.
Time Frame
Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Title
Change in neutralization antibody response
Description
Change in mean titers of neutralization antibody response will be measured using serum sample.
Time Frame
Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Title
Percentage of Participants with Vaccine Response
Description
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.
Time Frame
Month 13 (1 month post high-dose flu vaccination)
Secondary Outcome Measure Information:
Title
Percentage of T-follicular helper (Tfh) cells
Description
Percentage of Tfh cells as measured using peripheral blood samples
Time Frame
Month 13 (1 month post high-dose flu vaccination)
Title
Percentage of B cells
Description
Percentage of B cells as measured using peripheral blood samples
Time Frame
Month 13 (1 month post high-dose flu vaccination)
Title
Percentage of monocytes
Description
Percentage of monocytes as measured using peripheral blood samples
Time Frame
Month 13 (1 month post high-dose flu vaccination)
Title
Percentage of Tfh cells producing cytokines
Description
Percentage of Tfh cells producing cytokines as measured using peripheral blood samples
Time Frame
Month 13 (1 month post high-dose flu vaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria Contraindication to receive influenza vaccination. Non-adherence to ART for HIV positive Unable to provide informed consent. Influenza vaccination already given during the current vaccination season. Known drug abuse including cocaine by history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suresh Pallikkuth, PhD
Phone
3052435315
Email
spallikkuth@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savita Pahwa, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Pallikkuth, PhD
Phone
305-243-5315
Email
spallikkuth@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Savita Pahwa, MD
First Name & Middle Initial & Last Name & Degree
Suresh Pallikkuth, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Tfh Dysfunction in HIV and Aging

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