A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The number of adverse events after intramuscular injection
研究概览
简要总结
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
详细描述
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μg/0.5mL/bottle (low dose), 50μg/0.5mL/bottle (high dose) Indications: Prevention of respiratory diseases caused by new coronavirus infection Research population: healthy people ≥60 years old Research Unit: Hunan Provincial Center for Disease Control and Prevention Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose: Divided into low-dose group (25μg/0.5mL) and high-dose group (50μg/0.5mL).
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（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
The number of adverse events after intramuscular injection
时间窗: 12 months after full vaccination
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Immunogenic end point
时间窗: Within 6 months after the last dose of vaccination
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month and 6 months after the full vaccination And titer levels and their fold increase before immunity.
次要结局
未报告次要终点