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BRCA gene Carriers' immune system put to the test with flu shot

NCT ID NCT04499534

Knowledge-focused Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 2 times

Summary

This study checks how well the immune system works in healthy people with BRCA1 or BRCA2 gene mutations. About 50 adults over age 25 who carry these gene changes but have not had cancer will get a seasonal flu vaccine. Researchers will measure their antibody and immune cell responses to see if the mutation affects overall immune fitness.

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

About 50 people

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

Started

Oct 2019

Expected to finish

Jun 2027

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.

Who is studied

Patients 25 years and older, seen at Cancer Risk Evaluation Program (CREP) in the Perelman Center for Advanced Medicine with BRCA1 or BRCA2 mutation.

Ages

25 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: * Males and females * Over age 25 * BRCA1 or BRCA2 pathogenic or likely pathogenic mutation * No personal cancer history apart from non melanoma skin cancer, localized thyroid cancer, in situ cancers of any type * Participants must sign the informed consent form Exclusion Criteria: * Are allergic to influenza vaccination * Have received influenza vaccination within the past 6 months * Require prednisone, methotrexate, or other immunosuppressing medications * Have HIV infection * Have a history of solid organ tumor or bone marrow transplant * Require combination immunotherapy; * Are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

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Conditions

The condition(s) this trial relates to.

BRCA1-related cancer predisposition BRCA2-related cancer predisposition

As listed by the trial registrant

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

BRCA1 mutation BRCA2 mutation

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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