Studio Sierologico in Volontari Vaccinati Contro COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Change in Autoantibody Levels
研究概览
简要总结
Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.
详细描述
Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •Healthcare workers undergoing SARS-CoV-2 vaccination
排除标准
- •Pregnancy
- •Full blown autoimmune diseases
- •Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
- •Previous vaccination severe side effects
结局指标
主要结局
Change in Autoantibody Levels
时间窗: Before vaccination and 1, 6 and 12 months after vaccination
ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG
次要结局
未报告次要终点