BRCA1/2 Flu Vaccine

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04499534

Collaborator

(none)

Enrollment

Location

43.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA1 Mutation BRCA2 Mutation	Biological: Seasonal influenza vaccine

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Influenza Vaccine Study in BRCA1 or BRCA2 Carriers

Actual Study Start Date :

Oct 28, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

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

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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Susan Domchek, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT04499534

Other Study ID Numbers:

UPCC 11119
834194

First Posted:

Aug 5, 2020

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 18, 2022