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

R

Radboud University Medical Center

Status

Unknown

Conditions

PTEN Hamartoma Tumor Syndrome

Treatments

Biological: Influvac Tetra

Study type

Interventional

Funder types

Other

Identifiers

NCT03630523
NL66559.091.18

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Vaccination
Other group
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.
Treatment:
Biological: Influvac Tetra

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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