Follow-up Study of Population Vaccinated With COVID-19 Vaccine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- laboratory findings
研究概览
简要总结
A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.
详细描述
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.
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
- •Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.
排除标准
- •People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
- •People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
- •People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
- •People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
- •Pregnant woman
结局指标
主要结局
laboratory findings
时间窗: 6months
Clinical laboratory examination were obtained during follow-up.
symptoms and signs
时间窗: 6months
symptoms and signs after vaccination will be collected
antibody levels
时间窗: 6months
antibody levels will be collected
次要结局
未报告次要终点
研究者
Qin Ning
professor
Tongji Hospital