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

August 10, 2018 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Vaccination
Arm contains all subjects; vaccination with Influvac Tetra will be administered at start of study, response will be measured in 7 and 21 days.
Biological: Influvac Tetra
Tetravalent seasonal flu vaccination 2018/2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemagglutination inhibition assay titre
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proliferation assay
Time Frame: 21 days
21 days
interleukin profile
Time Frame: 21 days, 7 days
21 days, 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (ACTUAL)

August 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL66559.091.18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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