NCT00804219已完成4 期
Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
研究概览
简要总结
The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.
The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Adults (≥18 years) of both sexes without upper age limit
- •Willingness to sign written informed consent form
- •Basic vaccination plus one booster (minimum) of TBE-vaccine,
排除标准
- •Age: < 18 years
- •Pregnancy or breast feeding
- •Prior TBE infection
- •Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
- •Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
- •History of autoimmune disease
- •Drug addiction
- •Plasma donators
- •Administration of other vaccines 4 weeks before/after day 0
- •Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
- •Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
- •History of any malignant disease 5 years prior to the study entry
- •Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.
结局指标
主要结局
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
时间窗: 7 days after TBE-booster plus influenza vaccination
次要结局
未报告次要终点
研究者
研究点 (2)
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