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 range

65 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is tracking how older adults' antibody responses to influenza vaccines change over four years — given my age and health history, is this the kind of long-term commitment that makes sense for me to consider discussing with my care team?
2Since this is a Phase 4 trial studying vaccines already approved for use, does that mean the safety profile is better established compared to earlier-phase studies, and what does that mean for any additional risks I might face as a participant?
3The study focuses on dendritic cell activity and immune responses in aging — can you explain what that means for how my immune system might respond differently to flu vaccines compared to younger people, and whether that's relevant to my current flu vaccine choices?
4The trial is active but no longer recruiting new participants — does that mean there's any chance of joining, or should we focus our conversation on what standard next-generation flu vaccine options are available to me right now outside of a trial?
5Since this study measures antibody responses annually for up to four years, what would the time and visit commitments typically look like for something like this, and how might that factor into whether a study of this kind would be realistic for my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

65 Years

Sex

ALL

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