Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
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
- 否
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
Rebecca Cox
Professor
University of Bergen
