Cowden Syndrome PHTS
Conditions
Interventions
All subjects will be administered a registered flu vaccination (Influvac Tetra)
at T=0.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Diagnosed with a pathogenic PTEN mutatution leading to PHTS (for PHTS group) -18 years or older -Mentally capable -Must provide written informed consent -is registered at the radboudumc
Exclusion criteria
Exclusion criteria: -Known history of relevant medical disorder, which in the investigator's judgment might have an impact on the findings of the study, or ppose additional risk to the subject by participation in the study. -Hypersensitivity to previous influenza vaccinations -Must not be allergic to chicken eggwhite -Immunocomprimised patients and those receiving concomitant immunosuppressive therapy. -Bleeding disorders such as haemophilia and thrombocytopenia. -Must not have received vaccinations with attenuated pathogens in the 4 weeks leading up to the vaccination. -Acute infection or recent ilness similar to to influenza.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters will be counts per minute (cpm) as measure of T cell proliferation at baseline and at day 15. Also, the concentration of cytokines will be determined from blood samples at baseline and day 15( IFN-*, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, TNFa, TNF-β). Other secondary outcomes will be the proportions of seroconversion in both groups; defined as >=4 fold increase of titer, resulting in a titer of 1:40, and the seroprotection in both groups (rise to>= 1:40). This will be tested by Chi2 test. | — |
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be the concentration of antibody titres established by Hemaglutination Inhibition Assays At baseline and 15 days after vaccination with the seasonal flu vaccine. | — |
Countries
Netherlands
Outcome results
None listed