An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Occurrence of any SAEs (possibly)related to the study vaccine
研究概览
简要总结
The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.
A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
详细描述
This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Healthy adults ≥ 18 to </= 65
- •female subjects: post-menopausal or practicing reliable methods of contraception during the study
排除标准
- •History of autoimmune diseases and malignancies.
- •History of severe hypersensitivity reactions and anaphylaxis.
- •Immunodeficiency due to immunosuppressive therapy.
- •Infection with HIV, Hepatitis B or Hepatitis C.
- •Pregnancy, lactation
- •Vulnerable subjects
结局指标
主要结局
Occurrence of any SAEs (possibly)related to the study vaccine
时间窗: Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
时间窗: Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
时间窗: Day 0 - Day 264
次要结局
- Determination of vaccine-specific IgG levels(Day 0 - Day 264)