A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Geometric mean titers (GMTs)
研究概览
简要总结
This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. Subjects received a third dose of the COVID-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. On the 365th day, blood samples were collected for the detection of anti-SARS-CoV-2 antibodies and other related indicators to evaluate the immune protection effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years old, gender is not limited;
- •Subjects who completed the second dose of COVID-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine
排除标准
- •allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
- •those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
- •Receiving other research drugs within 3 months ;participating in other research vaccines Or subjects in clinical trials of research drugs;
- •other conditions that the investigator judges are not suitable for this clinical trial;
结局指标
主要结局
Geometric mean titers (GMTs)
时间窗: Day 28±3 after the third dose of vaccine injection
Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies
次要结局
- Geometric mean titers (GMTs)(Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection)
- IgG(Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection)
研究者
Wen-hong Zhang
chief physician
Huashan Hospital