Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Serum IgG antibodies levels in response to vaccine
研究概览
简要总结
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.
详细描述
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers.
The investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. The primary endpoint is serum IgG at the first month of 2nd jab, and at 3, 6, and 12 months afterward.
As secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to Covid-19 disease with potential spreading to inpatients.
Further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospital employers vaccinated against Sars-Cov2
排除标准
- 未提供
结局指标
主要结局
Serum IgG antibodies levels in response to vaccine
时间窗: Serum antibody at 12 months
Determination of IgG levels in serum
次要结局
- Sars-Cov2 infection in vaccinated subjects(up to 12 months)
- Covid-19 disease in vaccinated subjects(Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.)
研究者
Luigi Iuliano
Professor of Internal Medicine
University of Roma La Sapienza