Cohort Study to Measure COVID-19 Vaccine Effectiveness Among Health Workers in Albania
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- COVID-19 vaccine effectiveness
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the COVID-19 vaccine in hospital based HWs in Albania. This will answer critical questions about the real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.
详细描述
This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease.
The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers.
SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Health Workers eligible to receive the COVID-19 vaccination according to the national guidelines of Institute of Public Health.
- •Health Workers working at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.
- •Health Workers who have already been vaccinated against COVID-19 as part of the early COVID-19 vaccine rollout can be included, as long as information can be collected about the date and type of the vaccine that was administered. However, priority will be given to enrolling Health Workers who have received their COVID vaccine no more than 4 days prior to the day of enrolment in the study.
排除标准
- •Health Workers who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study.
- •Health Workers who do not work at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.
结局指标
主要结局
COVID-19 vaccine effectiveness
时间窗: 12 months
Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.
COVID-19 PCR confirmation
时间窗: 12 months
Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.
次要结局
- Vaccine effectiveness by age(12 months)
- Vaccine effectiveness by co-morbidities(12 months)