Status:

RECRUITING

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

Lead Sponsor:

The Jackson Laboratory

Collaborating Sponsors:

UConn Health

Icahn School of Medicine at Mount Sinai

Conditions:

Aging

Influenza Vaccine

Eligibility:

All Genders

65+ years

Phase:

PHASE4

Brief Summary

This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally fo...

Detailed Description

This prospective, single-arm study is designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults through the establishment of the FluVax3 cohort of heal...

Eligibility Criteria

Inclusion Criteria:

  • Able to speak and read English
  • Male or Female, 65 years and older by date of enrollment
  • Weight of 110 lbs or greater
  • Has received influenza vaccine in the past seasons without severe adverse reactions
  • Willing to receive an FDA-approved age-appropriate and CDC-recommended influenza vaccine for each of the 2022-23, 2023-24, and 2024-25 influenza seasons
  • Willing to withhold all other vaccinations 2 weeks prior and 2 weeks after flu vaccination for the 2022-23, 2023-24, and 2024-25 influenza seasons
  • Willing and available to participate in 19 study visits over three years around influenza vaccination
  • Willing to provide blood samples at sixteen visits over three years
  • Willing to agree to genomic testing of samples and sharing of de-identified genomic data generated from samples at the conclusion of the research

Exclusion Criteria:

  • Received any vaccine (shingles, pneumococcal, COVID, etc.) within 2 weeks of anticipated flu vaccination for the 2022-23, 2023-24, and 2024-25 influenza seasons.

  • Has already received an influenza vaccine for the approaching influenza season (2022-23)

  • Has known allergy to eggs or any component of the flu vaccine. [Although the Advisory Committee on Immunization Practices (ACIP) has concluded that a history of anaphylactic/anaphylactoid or severe allergic reaction to eggs should no longer be considered a contraindication to vaccination with any age-appropriate vaccine, for the purposes of this research study we elected to exclude individuals with these allergies]

  • History of Guillain-Barre syndrome (GBS)

  • Body temperature greater than 100.3°F (38°C) on date of vaccination or within 2 days prior to vaccination by participant report (study entry may be delayed to meet this requirement)

  • Rockwood Frailty Index score of >0.21

  • Known history of any of the following co-morbid conditions:

    • Chronic or recent (within past 2 months) infection requiring oral or intravenous antibiotics, antifungals, or antivirals
    • Cancer other than basal cell carcinoma requiring active surgical or medical treatment (chemotherapy or radiation therapy)
    • Congestive Heart Failure
    • Ischemic Heart Disease
    • Congenital abnormalities (PI to evaluate)
    • Paget's disease
    • Renal failure requiring ongoing dialysis
    • Chronic obstructive pulmonary disease, emphysema, or asthma
    • Severe autoimmune disease requiring biological therapy
    • Diabetes mellitus requiring insulin
    • Use of medicines during past 6 months known to alter immune response such as high-dose corticosteroids (≥ 10 mg/day of prednisone or equivalent)
    • HIV, AIDS or other immunodeficiency disorders
    • Recent (≤ 3 months) severe trauma or major surgery (PI to evaluate)
    • Current substance and/or alcohol abuse
  • Patients currently residing in the Department of Correction

  • Inability to comply with the protocol requirements

  • Any other condition that, in the opinion of the PI, might interfere with study objectives

Key Trial Info

Start Date :

August 31 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT05518500

Start Date

August 31 2022

End Date

December 31 2026

Last Update

September 19 2024

Active Locations (1)

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UConn Health, Center On Aging

Farmington, Connecticut, United States, 06030

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults | DecenTrialz