An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence Rate of Adverse Event
研究概览
简要总结
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Indication: Protection against varicella and herpes zoster
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Study Objectives
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Primary: Safety and tolerability assessment after single dose administration of NBP608
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Secondary: immunogenicity assessment after single dose administration of NBP608
详细描述
This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 20 and over
- •Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
- •Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
- •Subjects of seropositive for Varicella-Zoster virus at screening visit
排除标准
- •Patients with herpes zoster
- •Subjects with a history of vaccination for herpes zoster
- •Pregnant or lactating women
- •Participants in another clinical study within 4 weeks before vaccination in this study, etc.
结局指标
主要结局
Incidence Rate of Adverse Event
时间窗: 42days after Investigation Product Vaccination
次要结局
- Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)(42days after Investigation Product Vaccination)
- Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)(42days after Investigation Product Vaccination)