Active — Not RecruitingPhase 4

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

United States75 participantsStarted 2022-08-31

Plain-language 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. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with a different FDA approved influenza vaccine and participate in study visits for Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 w…

What they're measuring

Change in Antibody Responses to Influenza Vaccine Year One

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Two

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Three

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Four

Timeframe: Baseline, Day 35, Day 180

Trial details

NCT IDNCT05518500

SponsorThe Jackson Laboratory

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Antibody Responses to Influenza Vaccine Year One

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Two

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Three

Timeframe: Baseline, Day 35, Day 180

Change in Antibody Responses to Influenza Vaccine Year Four

Timeframe: Baseline, Day 35, Day 180