Response of Immune System to Flu Vaccination in PHTS

PTEN Hamartoma Tumor Syndrome Clinical Trial

— RIPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03630523
• Other study ID #: NL66559.091.18
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hamartoma Syndrome, Multiple
• Neoplasms
• PTEN Hamartoma Tumor Syndrome
• Syndrome

Intervention

Biological:
• Influvac Tetra
Tetravalent seasonal flu vaccination 2018/2019

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutination inhibition assay titre		7 days
Secondary	Proliferation assay		21 days
Secondary	interleukin profile		21 days, 7 days