A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- GMT of neutralizing antibody against SARS-CoV-2
研究概览
简要总结
This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.
详细描述
This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.
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 55 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
结局指标
主要结局
GMT of neutralizing antibody against SARS-CoV-2
时间窗: Day 85
Evaluation of Immunogenicity
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
时间窗: Day 85
Evaluation of Immunogenicity
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
时间窗: Within 7 days after vaccination
Evaluation of Safety
次要结局
- Correlation between the immune response detected by ELISA and live virus neutralization test(During the study period)
- Occurrence of SAEs, AESIs, MAAEs and SAEs(During the study period)
- GMT of antigen-specific antibody (Anti-S1-RBD)(Day 85)
- Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)(Day 85)