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Age may alter vaccine immunity: new study investigates

NCT ID NCT04852289

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looks at how the immune systems of younger and older adults respond to Pfizer or Moderna COVID-19 vaccines. Researchers will collect blood samples from 78 healthy volunteers over two years to measure specific T-cell responses. The goal is to understand if age changes how well the vaccine works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how age impacts immune response to COVID-19 vaccines, helping improve future vaccine strategies.
What could go wrong
This is an observational study, not a treatment trial. It only measures immune markers and may not lead to direct health changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Participants

78 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

The participants will consist of healthy men and women over 18 years of age who plan to have a COVID-19 vaccination within 30 days. An accrual ceiling of 160 participants will be recruited and screened until 140 eligible participants are enrolled, which are calculated based on four groups: young females (18-64), young males (18-64), old females (\>=65), old males (\>=65). Each group with 35 people to account for HLA-A2+, variations in HLA-A2 genotype percentage, and possible dropout. We will include both genders, 18 years of age and older, all races, and residents of the state of Maryland.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female aged 18 years or older. * Able to speak and read English. * Willingness and ability to come to the NIH/National Institute on Aging Clinical Research Unit at MedStar Harbor Hospital or the NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus in Baltimore for study procedures. * No knowledge of having had SARS-CoV-2, the virus that causes COVID-19. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required. * Unable to provide informed consent. * Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications. * Pregnancy. In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include: * Symptoms of a viral infection on visit 1 (defer until resolved). * Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials, antivirals. * Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal, inhaled, or for joint injection. * Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well. * We wish to only select healthy confirmed COVID-19 negative patients. Therefore, those who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or who has symptoms will be deferred for 14 days. * Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.

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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

  • NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus

    Baltimore, Maryland, 21244, United States

  • National Institute of Aging, Clinical Research Unit

    Baltimore, Maryland, 21224, United States

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