跳至主要内容
临床试验/NCT04706390
NCT04706390招募中不适用

Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

University of Bergen1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
1
主要终点
immune responses

研究概览

简要总结

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.

详细描述

The primary aim of this study is

  • To compare immune responses after natural SARS-CoV-2 infection and COVID-19 vaccination The secondary aims are
  • To compare the duration and breadth of antibody responses between natural infection and vaccination.
  • To investigate the duration and breadth of B and T cellular responses between natural infection and vaccination.
  • To evaluate the short and long term complications after natural infection and vaccination.
  • To find out if previous infection skews the immune response after vaccination.
  • To study reinfection after natural infection and 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
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects prioritized by national vaccination program

排除标准

  • unable or unwilling to provide informed consent

结局指标

主要结局

immune responses

时间窗: 2 months to 3 years

spike antibody response to SARS-CoV-2

次要结局

  • Duration and breadth of T cell responses(2 months to 3 years)
  • Duration and breadth of B- cell responses(2 months to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Cox

Professor

University of Bergen

研究点 (1)

Loading locations...

相似试验