Clinical trial · Interventional
Response of Immune System to Flu Vaccination in PHTS
Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
NCT03630523CI-TRIAL-00034379RIPSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PTEN Hamartoma Tumor Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Influvac Tetra | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Vaccination
- 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.
- interventionNames
- Biological: Influvac Tetra
Primary outcomes (1)
- measure
- Hemagglutination inhibition assay titre
- timeFrame
- 7 days
Secondary outcomes (2)
- measure
- Proliferation assay
- timeFrame
- 21 days
- measure
- interleukin profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.