Why do flu shots weaken with age? new study aims to find out

NCT ID NCT05518500

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study follows 75 adults aged 65 and older over three to four flu seasons to learn why the flu vaccine becomes less effective as people age. Participants will receive a different FDA-approved flu vaccine each year, and researchers will collect blood, nasal swab, and stool samples to measure immune responses. The goal is to understand the biological changes behind reduced vaccine response, not to test safety or effectiveness of the vaccines.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UConn Health, Center On Aging

    Farmington, Connecticut, 06030, United States

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Other studies related to the condition(s) this trial covers.