Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome

Radboud University Medical Center0 sites30 target enrollmentOctober 2018

ConditionsPTEN Hamartoma Tumor Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PTEN Hamartoma Tumor Syndrome
Sponsor: Radboud University Medical Center
Enrollment: 30
Primary Endpoint: Hemagglutination inhibition assay titre
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.

Registry

clinicaltrials.gov

Start Date

October 2018

End Date

January 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Radboud University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be diagnosed with PHTS based on genetic testing
•Must be a Radboudumc patient
•Must be 18 years or older
•Must be mentally competent
•Must have provided written informed consent to participate in the study
•Must be able to adhere to visit schedule and available to complete the study

Exclusion Criteria

•• Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study
•Known hypersensitivity to previous influenza vaccinations (Anaphylaxis)
•Must not be allergic to chicken eggwhite
•Pregnancy at start of study
•Immunocompromised patients and those receiving concomitant immunosuppressive therapy or other immune modulating drugs including chronic steroid treatment.
•Bleeding disorders including haemophilia and thrombocytopenia or treatment with anticoagulants(Due to risk of intramuscular hematoma after injection)
•Must not have received vaccination with attenuated pathogens in the 4 weeks leading up to study. (Measles, mumps, rubella, yellow fever, rotavirus, BCG, typhoid)