Against Pseudomonas Aeruginosa in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 3
- 主要终点
- immunogenicity at day 14
研究概览
简要总结
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
详细描述
The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent obtained prior to study entry
- •healthy adults aged between 18 and 65 years
- •no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
- •In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
排除标准
- •History of autoimmune diseases and malignancies
- •Active or passive vaccination 4 weeks before and during the entire study protocol
- •Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •History of severe hypersensitivity reactions and anaphylaxis
- •Known hypersensitivity or allergic reactions to one of the components of the vaccine
- •Clinically significant diseases as judged by the investigator
- •Immunodeficiency due to immunosuppressive therapy
- •A family history of congenital or hereditary immunodeficiency
研究组 & 干预措施
IC43 50
IC43 50 mcg with AI(OH)3
干预措施: IC43 (Biological)
IC43 100 with
IC43 100 mcg with AI(OH)3
干预措施: IC43 (Biological)
IC43 100 w/o
IC43 100 mcg w/o AI(OH)3
干预措施: IC43 (Biological)
IC43 200
IC43 200 mcg with AI(OH)3
干预措施: IC43 (Biological)
Placebo
Placebo (0,9% NaCl)
干预措施: Placebo (Drug)
结局指标
主要结局
immunogenicity at day 14
时间窗: see above
rate of serious adverse events during vaccination period until 6 months after first vaccination
时间窗: see above
safety laboratory parameters at intervals up to day 180
时间窗: see above
systemic and local tolerability at intervals up to day 180
时间窗: see above
次要结局
- immunogenicity(see above)
- measurement of functional antibody induction(see above)
- measurement of antibody avidity on days 7 and 14(see above)
- measurement of anti-histidine antibodies on days 7, 14, 90, and 180(see above)