Estimation of Dynamics of Humoral Immunity in COVID-19 Vaccined Health Care Workers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Vaccine effectiveness
研究概览
简要总结
The purpose of the research is to evaluate kinetic after vaccination to the COVID-19 coronavirus by measurements of specific and neutralizant antibodies for spike antigenic sequences .
This work will allow us to follow the efficacy and tolerance of the vaccine over a year, to evaluate the antibody profile, their kinetics, the fraction of neutralising antibodies and will also allow us to understand the attitudes to be taken to ensure the best protection for our staff
详细描述
Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:
G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology <0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination.
- •Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination.
- •Sampling Frequency and timing: Up to 8 total samples in 12 months -
排除标准
- •Exclusion: Failure to provide informed consent
结局指标
主要结局
Vaccine effectiveness
时间窗: 1 year
antibody kinetics
次要结局
- the tolerance of the vaccine(1 year)