NCT03630523Unknown不适用
Registering the Immune Response to a Flu Vaccination Challenge in PTEN Hamartoma Tumour Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Hemagglutination inhibition assay titre
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •• 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)
研究组 & 干预措施
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.
干预措施: Influvac Tetra (Biological)
结局指标
主要结局
Hemagglutination inhibition assay titre
时间窗: 7 days
次要结局
- Proliferation assay(21 days)
- interleukin profile(21 days, 7 days)
研究者
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