Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
研究概览
简要总结
FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.
详细描述
Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •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 day 0
- •planned surgery within 2 weeks before/after TBE booster vaccination
- •specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
- •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
intra muscular application
intra muscular application of FSME-Immune vaccination
干预措施: FSME-Immune vaccination (Biological)
subcutaneous application
subcutaneous application of FSME-Immune vaccination
干预措施: FSME-Immune vaccination (Biological)
结局指标
主要结局
Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
时间窗: 1 month
GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
次要结局
- TBE Titer Profile(before (day 0) and 1week, 1 month, 6 months after booster vaccination)
- Cellular Immune Responses - Cytokines(before (day 0) and 1 week after booster vaccination)
研究者
Univ. Prof. Dr. Ursula Wiedermann
Univ.-Prof. Dr. Ursula Wiedermann
Medical University of Vienna