Clinical trial

Influenza Vaccine Study in BRCA1 or BRCA2 Carriers

Name

UPCC 11119

Description

To evaluate immune function in BRCA1/2 mutation carriers without cancer, specifically to determine whether immune function in healthy individuals with germline loss of function BRCA1/2 mutations, impacts overall immune health and fitness.

Trial arms

Trial start

2019-10-28

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Treatment

Seasonal influenza vaccine

To evaluate immune function in BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination

Size

Primary endpoint

To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination

2 years

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-10-10

1 organization

1 product

2 indications

Organization

Abramson Cancer Center at Penn Medicine

Product

Seasonal influenza vaccine

Indication

BRCA1 Mutation

Indication

BRCA2 mutation