TBE (Tick-borne Encephalitis ) Vaccination in Allergic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Humoral TBE Immunity
研究概览
简要总结
Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.
详细描述
Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune suppressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (Tick-borne Encephalitis [TBE] booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •completed primary TBE immunization + at least one booster immunization
- •adults of both sexes between 18 and 60 years of age
- •willingness to sign written informed consent form
排除标准
- •age < 18 and > 60 years
- •prior TBE infection
- •Hepatitis A vaccination
- •pregnancy and breast feeding
- •acute infection on day of inclusion (day 0), body temperature >37,9°C
- •concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
- •administration of other vaccines 4 weeks before/after TBE vaccination
- •planned surgery within 2 weeks before/after TBE vaccination
- •Start of de-sensitization and the first 4 weeks of allergen dose escalation
- •any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
- •history of malignant disease within the last 5 years
- •autoimmune diseases
- •drug addictions
- •plasma donors
- •receipt of blood transfusions or immuno globulins within 3 month before study entry
研究组 & 干预措施
Allergic patients
Allergic patients receive TBE booster vaccination
干预措施: TBE booster vaccination (Biological)
Allergic patients with de-sensitization treatment
Allergic patients with de-sensitization treatment receive TBE booster vaccination
干预措施: TBE booster vaccination (Biological)
Healthy controls
Healthy controls receive TBE booster vaccination
干预措施: TBE booster vaccination (Biological)
结局指标
主要结局
Humoral TBE Immunity
时间窗: one month after booster vaccination
Geometric mean titers of TBE specific neutralizing Abs
次要结局
- TBE Titer Course(before (day 0) until 6 months after booster vaccination)
- Cellular Immune Response - Lymphocyte Subpopulations(before (day 0) and 1week after booster vaccination)
- Cellular Immune Response - Cytokine Production(before (day 0) and 1week after booster vaccination)
研究者
Univ. Prof. Dr. Ursula Wiedermann
Univ.-Prof. Dr. Ursula Wiedermann, MD, PhD
Medical University of Vienna