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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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 follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
United States
Connecticut
UConn Health, Center On Aging
RECRUITING
Farmington
Contact Information
Primary
Lisa Kenyon-Pesce, MPH
kenyon-pesce@uchc.edu
860-679-2305
Backup
George Kuchel, MD, FRCP
kuchel@uchc.edu
860-679-6796
Time Frame
Start Date: 2022-08-31
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 75
Treatments
Experimental: Healthy Older Adults
Will receive FDA-approved influenza vaccine (Fluzone HD Year 1, FLUAD Year 2, Flublok Quadrivalent Year 3)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Weill Medical College of Cornell University, UConn Health, Icahn School of Medicine at Mount Sinai, University of Chicago
Leads: The Jackson Laboratory

This content was sourced from clinicaltrials.gov