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临床试验/NCT04709003
NCT04709003已完成不适用

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI): A Prospective Cohort Study

Clalit Health Services6 个研究点 分布在 1 个国家目标入组 1,567 人开始时间: 2020年12月23日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ran Balicer

Chief Innovation Officer, Clalit Health Services

Clalit Health Services

研究点 (6)

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