Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of anti-SARS-CoV-2 T cell response
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.
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 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and aged between 18 to 59 years
排除标准
- •High-risk epidemiology history within 14 days before enrollment
- •SARS-CoV-2 specific IgG or IgM positive in serum
- •Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples
- •Axillary temperature of more than 37·0°C
- •Known allergy to any vaccine component
- •Thyroid disease
结局指标
主要结局
Rate of anti-SARS-CoV-2 T cell response
时间窗: 2 years
The rate of SARS-CoV-2 infection
时间窗: 2 years
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
时间窗: 2 years
Concentration of serum anti-SARS-CoV-2 binding antibody
时间窗: 2 years
次要结局
- Rate of anti-SARS-CoV-2 B cell response(2 years)
研究者
Chao Wu
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
