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Trial record 1 of 6 for:    PTEN hamartoma tumor syndrome
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Response of Immune System to Flu Vaccination in PHTS (RIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03630523
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
PTEN Hamartoma Tumor Syndrome Biological: Influvac Tetra Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hemagglutination inhibition assay titre [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Proliferation assay [ Time Frame: 21 days ]
  2. interleukin profile [ Time Frame: 21 days, 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

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Responsible Party: Radboud University Identifier: NCT03630523     History of Changes
Other Study ID Numbers: NL66559.091.18
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:

Additional relevant MeSH terms:
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Hamartoma Syndrome, Multiple
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Pathologic Processes
Genetic Diseases, Inborn
Immunologic Factors
Physiological Effects of Drugs