A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada
试验速览
- 阶段
- 1 期
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Incidence of the Solicited AE in all groups
研究概览
简要总结
This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age，with the randomized, observer-blind, dose-escalation design
详细描述
A total of 96 healthy adult volunteers will be vaccinated in phase I stepwised according to the dose-escalation design from the younger adults(18 to <55) to the older adults(65 to <85). There are 2 dosage level used in this phase: 5E10vp and 10E10vp, and 2 dose schedules: single dose and 2 dose. According to the pre-defined adaptive design standards, the trial will moved from Phase I to Phase II. In the phase II portion, A total of 600 healthy adult volunteers will be vaccinated according to the dose-escalation design from the younger adults(18 to <55) to the older adults(55 to <85). There are 2 dosage levels and schedules used in this phase，and will determine a final dose and schedule by the end. Some cohorts in the phase II trial will be included in the subsequent phase III trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older 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
Incidence of the Solicited AE in all groups
时间窗: 0-6 days after each vaccination
The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
Incidence of Unsolicited AE in all groups
时间窗: 0-28 days after each vaccination
The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.
Incidence of Serious adverse events (SAE) in all groups
时间窗: 6 months after the final vaccination
The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
次要结局
- Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);(Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group)
- Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method )(Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group)
- Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)(Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group)
- Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector(Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group)
- Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector(Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group)
- Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);(Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group)
- Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)(Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group)
- Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)(Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group)
- cellular immune response by ICS(Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group)
- cellular immune response by ELISpot(on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group)