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OpenTrials
Active, Not Recruiting

NCT Number: NCT04499534

BRCA1/2 Flu Vaccine

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

BRCA1 Mutation BRCA2 Mutation

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seasonal Influenza Vaccine

Biological

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Exploratory analysis- phenotypic evaluation of B cell

    Time frame: 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).

  2. Exploratory analysis - transcriptional evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Influenza Vaccine Study in BRCA1 or BRCA2 Carriers

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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