Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,567
- 试验地点
- 6
- 主要终点
- COVID-19 vaccine effectiveness (VE)
研究概览
简要总结
Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine in preventing symptomatic infection, many questions about vaccine effectiveness, such as the effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for transmission, and duration of protection, can only be evaluated in real-world trials. The objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of Health guidelines, will be recruited, regardless of their intention to get the COVID-19 vaccine. A baseline serology sample and respiratory sample will be collected. Participants will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6 months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR; serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For each participant, data will be extracted from the Electronic Medical Record for the period of the study and retrospectively from 2010.
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
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any HCP at any of the participating hospitals who is
- •a member of Clalit Health Services
- •is eligible to get the Covid-19 vaccine
- •did not receive the first dose of COVID-19 vaccine more than 21 days prior to the enrollment date
排除标准
- •Employees at any of the participating hospitals will be excluded if they are:
- •not a member of Clalit Health Services; or
- •not eligible to get the Covid-19 vaccine according to the Ministry of Health guidelines; or
- •Less than 18 years of age
- •Received first dose of COVID-19 vaccine more than 21 days prior to date of enrollment
结局指标
主要结局
COVID-19 vaccine effectiveness (VE)
时间窗: 18 months
Incidence of SARS-CoV-2 infections in healthcare workers vaccinated with COVID-19 vaccine compared to unvaccinated healthcare workers
次要结局
- Vaccine effectiveness of one dose compared to two doses(18 months)
- Symptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers(18 months)
- VE by different SARS-CoV-2 variants(18 months)
- Duration of effectiveness of the vaccine(18 months)
- Vaccine effectiveness in persons previously infected with SARS-CoV-2 virus(18 months)
- Compartive vaccine Effectiveness of different vaccine brands(18 months)
- asymptomatic SARS-CoV-2 infection in vaccinated vs. unvaccinated healthcare workers(18 months)
- Vaccine Effectiveness by age(18 months)
- VE by degree of exposure to COVID-19 patients(18 months)
- Vaccine Effectiveness by comorbidity(18 months)
研究者
Ran Balicer
Chief Innovation Officer, Clalit Health Services
Clalit Health Services
