NCT04487041

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Oct 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2020Dec 2026

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

5.7 years

First QC Date

July 22, 2020

Last Update Submit

May 28, 2025

Conditions

Human Influenza

Keywords

HIVAgingflu vaccinationhigh dose vaccinationimmune function

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Percentage of T-follicular helper (Tfh) cells

    Month 13 (1 month post high-dose flu vaccination)

  • Percentage of B cells

    Month 13 (1 month post high-dose flu vaccination)

  • Percentage of monocytes

    Month 13 (1 month post high-dose flu vaccination)

  • Percentage of Tfh cells producing cytokines

    Month 13 (1 month post high-dose flu vaccination)

Study Arms (4)

Young HIV negative group

ACTIVE COMPARATOR

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.

Biological: Standard dose influenza vaccinationBiological: High dose influenza vaccination

Young HIV positive group

EXPERIMENTAL

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.

Biological: Standard dose influenza vaccinationBiological: High dose influenza vaccination

Old HIV negative group

EXPERIMENTAL

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.

Biological: Standard dose influenza vaccinationBiological: High dose influenza vaccination

Old HIV positive group

EXPERIMENTAL

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.

Biological: Standard dose influenza vaccinationBiological: High dose influenza vaccination

Interventions

Standard dose influenza vaccinationBIOLOGICAL

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

Also known as: Fluzone quadrivalent
Old HIV negative groupOld HIV positive groupYoung HIV negative groupYoung HIV positive group
High dose influenza vaccinationBIOLOGICAL

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

Also known as: Fluzone high dose quadrivalent
Old HIV negative groupOld HIV positive groupYoung HIV negative groupYoung HIV positive group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Savita Pahwa, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suresh Pallikkuth, PhD

CONTACT

3052435315spallikkuth@med.miami.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

October 30, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)