BRCA1/2 Flu Vaccine

N/AActive Not RecruitingNCT04499534

Abramson Cancer Center at Penn Medicine50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

BRCA1 Mutation BRCA2 Mutation

Interventions

Seasonal influenza vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Analysis of the primary objective will depend on determination of the strain-specific neutralizing antibody titer change from day 0 to the last study visit, performed as the standard assay as described by the World Health Organization (WHO).

Time frame: 2 years

Secondary Outcomes

Exploratory analysis- phenotypic evaluation of B cell

Phenotypic evaluation of B and T cell responses to vaccine at each timepoint. Phenotypic analysis involves flow cytometry on peripheral blood mononuclear cells (PBMC) from all subjects (10 mL blood per subject).

Time frame: 2 years

Exploratory analysis - transcriptional evaluation

Transcriptional evaluation of B and T cell responses to vaccine on day 7-10 timepoint. Transcriptional analyses including quantitative real-time PCR (RT-qPCR) and RNA sequencing (RNAseq) may be performed on a subset of the study subjects on the day 7-10 time point.

Time frame: 2 years

Data from ClinicalTrials.gov

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