A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
研究概览
简要总结
A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health
详细描述
The purpose of this study is to provide the needed safety and immunogenicity data to support rapid deployment of the SEBOV vaccine against an ongoing or future outbreak.
The intervention will be a single dose and will either be study vaccine named rVSVΔG-SEBOV-GP Vaccine, or placebo (a placebo is an inactive substance or other intervention that looks the same as and is given the same way as study vaccine or treatment being tested)
There are 3 group in this study, each group has different vaccine doses. Group 1 starts with the lowest dose of the study vaccine and each subsequent group Groups 2 and Group 3 gets a higher dose of the study vaccine.
Approximately 36 participants will be included in the study.
The participant will be unaware of the treatment given between placebo and study vaccine.
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
- Single (Participant)
盲法说明
It is a single blind study. The participant will be unaware of the intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study Group 1
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^6 pfu intramuscularly Day 1
干预措施: rVSV∆G-SEBOV-GP Vaccine or Placebo (Drug)
Study Group 2
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^7 pfu intramuscularly Day 1
干预措施: rVSV∆G-SEBOV-GP Vaccine or Placebo (Drug)
Study Group 3
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^8 pfu intramuscularly Day 1
干预措施: rVSV∆G-SEBOV-GP Vaccine or Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
时间窗: 14 days
Proportion of participants with vaccine-related SAEs throughout the study period
次要结局
- To determine SEBOV-GP-specific antibody responses induced by rVSVΔG-SEBOV-GP vaccine(6.5 months)