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Response of Immune System to Flu Vaccination in PHTS (RIPS)

Primary Purpose

PTEN Hamartoma Tumor Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Influvac Tetra
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PTEN Hamartoma Tumor Syndrome focused on measuring PHTS, PTEN, Vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Vaccination

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Hemagglutination inhibition assay titre

    Secondary Outcome Measures

    Proliferation assay
    interleukin profile

    Full Information

    First Posted
    August 10, 2018
    Last Updated
    August 10, 2018
    Sponsor
    Radboud University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03630523
    Brief Title
    Response of Immune System to Flu Vaccination in PHTS
    Acronym
    RIPS
    Official Title
    Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PTEN Hamartoma Tumor Syndrome
    Keywords
    PHTS, PTEN, Vaccination

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaccination
    Arm Type
    Other
    Arm Description
    Arm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days.
    Intervention Type
    Biological
    Intervention Name(s)
    Influvac Tetra
    Intervention Description
    Tetravalent seasonal flu vaccination 2018/2019
    Primary Outcome Measure Information:
    Title
    Hemagglutination inhibition assay titre
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Proliferation assay
    Time Frame
    21 days
    Title
    interleukin profile
    Time Frame
    21 days, 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Learn more about this trial

    Response of Immune System to Flu Vaccination in PHTS

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