Response of Immune System to Flu Vaccination in PHTS

Not Applicable

• Conditions: PTEN Hamartoma Tumor Syndrome
• Interventions: Biological: Influvac Tetra

• Registration Number: NCT03630523
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Study Start: 2018-10
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccination	Influvac Tetra	Arm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days.

Primary Outcome Measures

Name	Time	Method
Hemagglutination inhibition assay titre	7 days

Secondary Outcome Measures

Name	Time	Method
Proliferation assay	21 days
interleukin profile	21 days, 7 days