Response of Immune System to Flu Vaccination in PHTS

NCT03630523 | Unknown

• 1 other identifier: NL66559.091.18
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTEN Hamartoma Tumor Syndrome

Keywords

PHTS; PTEN; Vaccination

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibition assay titre

  7 days

Secondary Outcomes (2)

• Proliferation assay

  21 days

• interleukin profile

  21 days, 7 days

Study Arms (1)

Vaccination

OTHER

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

Interventions

Influvac Tetra BIOLOGICAL

Tetravalent seasonal flu vaccination 2018/2019

Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Hamartoma Syndrome, Multiple

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08