BRCA1/2 Flu Vaccine

Active, not recruiting

• Conditions: BRCA1 Mutation; BRCA2 Mutation

• Registration Number: NCT04499534
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination	2 years	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).

Secondary Outcome Measures

Name	Time	Method
Exploratory analysis - transcriptional evaluation	2 years	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.
Exploratory analysis- phenotypic evaluation of B cell	2 years	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).

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States