Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 7
- 主要终点
- Number of HCW involved in the study
研究概览
简要总结
The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).
详细描述
Background: Protection from SARS-CoV-2 infection is known to occur soon after vaccination or natural disease, fading over time. Although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. Recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. Study objectives: The EuCARE-HCW study contributes with data and samples from
HCW to EuCARE-IMMUNITY study that will analyse the NtAb and CMI to different SARS- CoV-2 variants following any combination of natural infection and vaccination. Specific
objectives include:
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to collect data and biological material from COVID-19 healthcare workers in 9 clinics from 8 countries and 3 continents.
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Enrolment of HCW with an immunogenic event, either vaccination or infection.
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Periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists).
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Sample preparation, storage and shipment to central EuCARE laboratories where WP2 study group will analyse natural and artificial immunity to SARS-CoV-2 variants (EuCARE-IMMUNITY), namely:
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Analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination.
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Define the cross-immunity among the different viral variants.
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Analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s).
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To accomplish the above objectives, WP2 will test:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study subjects will be selected based on the following inclusion criteria:
- •Adult (>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status.
- •For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
- •Having a signed informed consent when required by ethical approval
排除标准
- 未提供
结局指标
主要结局
Number of HCW involved in the study
时间窗: through study completion, an average of 3 years
To collect the higher possible number of data and biological materials from the HCWs of the participating Units
次要结局
未报告次要终点