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临床试验/NCT04729374
NCT04729374Unknown不适用

Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月27日最近更新:
适应症

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

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

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chao Wu

Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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