Seroprevalence of SARS-CoV-2 Antibodies and Development of Immunity in a Public School Population - a Population-based Observational Study to Inform Policy Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,250
- 试验地点
- 1
- 主要终点
- Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies
研究概览
简要总结
There is a lack of knowledge about how many children are infected with SARS-CoV-2, how often they are asymptomatic, and how long the immunity persists.
The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and risk factors in a representative cohort of children and adolescents in the canton of Zurich, Switzerland, shortly after re-opening of the school system and thereafter. The study also investigates antibodies to SARS-CoV-2 in parents of the children and school personnel.
详细描述
The role of children and adolescents in the transmission of SARS-CoV-2 remains highly unclear and has been a key question since the early days of the pandemic. It has important consequences for policy decisions, especially concerning the opening of the schools, sport facilities and intergenerational contacts. However, the information on true infection rate and seroprevalence of SARS-CoV-2 is not known in children in Switzerland (and globally), as testing was limited to risk groups and those with SARS-CoV-2 coronavirus disease 2019 (COVID-19) related symptoms. In addition, indications for testing were not uniform and handled heterogeneously. Hence, it is not known whether children are less frequently infected or simply less symptomatic.
This study builds up a system to monitor the seroprevalence of SARS-CoV-2 in children and adolescents who attend school in the canton of Zürich, Switzerland. The investigators aim to assess children of randomly selected primary and secondary schools during the first weeks of re-entering school from all districts of the canton of Zurich in June and July 2020, after the temporary closure due to COVID-19 pandemic, and again in October/November 2020, February/March 2021, November/December 2021, and again in the second half of 2022. The detailed time plan including possible further assessments will be defined depending on the evolution of the pandemic (e.g., 2023). A follow-up capturing health status, symptoms and behaviors over time is important, since it is currently under investigation whether persons may be at risk for reinfection. Thus, a longitudinal assessment is crucial to determine the extent and duration of immunity.
In addition, the seroprevalence of SARS-CoV-2 in the parents of the participating children will be tested in August/September 2020, to examine clusters of infections in households. Seroprevalence of SARS-CoV-2 in school personnel will be tested in August/September 2020 and subsequently in October/November 2020 and February/March 2021, to examine temporal changes in the seroprevalences in the whole school community. Further testing of adults is not planned.
In different subpopulations, further in-depth analysis of immunity markers will be performed in the future.
This study complements the ongoing coordinated efforts of seroprevalence studies in adults in Switzerland, through the Swiss School of Public Health (SSPH+) coordinated CORONA IMMUNITAS studies.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any school child residing in Switzerland aged 5 years or older and attending a consenting to participate public or private school that hosts classes of interest (grade 1 through 9) in the canton of Zürich.
- •Parents of participating children.
- •Personnel employed in the participating schools.
- •No acute respiratory and SARS-CoV-2 infection:
- •In case of unknown respiratory infection, no presence of symptoms for at least 48 hours.
- •In case of confirmed SARS-CoV-2 infection: inclusion at the earliest 21 days from PCR-positive diagnosis after the onset of potential symptoms and no presence of symptoms for at least 48 hours (according to Standard of Care).
- •Informed consent of parents or legal guardians and children, or the adult participant.
排除标准
- •No informed consent by schools or children, or the adult participant.
- •Schools with <40 students in one of the sampled grades (1, 2, 4, 5, 7, or 8).
- •Children of Kindergarten age and younger.
- •Suspicion of acute COVID-19 infection.
- •Special need schools.
结局指标
主要结局
Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies
时间窗: Month 8-9
Seroprevalence of SARS-CoV-2 IgG, IgM and/or IgA antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 8-9 months after recruitment in the canton of Zürich, Switzerland.
Seroprevalence of SARS-CoV-2 IgG antibodies
时间窗: Month 24-30
Seroprevalence of SARS-CoV-2 IgG antibodies in randomly selected 5- to 16-year-old population of school-children and school personnel after 24-30 months after recruitment in the canton of Zürich, Switzerland.
次要结局
- Incidence of symptoms in initially seropositive participants(within 36 months of follow-up)
- Self-reported lifestyle changes of participants at inclusion(at inclusion)
- Self-reported mental well-being (HBSC questionnaire)(within 36 months of follow-up)
- Prevalence of seropositive SARS-Cov-2 clusters in schools at inclusion(at inclusion)
- Change in seropositive participants within school or class, depending on the initial proportion of seropositive participants(within 36 months of follow-up)
- Effect of risk factors and preventive measures on SARS-CoV-2 infection incidence within schools(within 36 months of follow-up)
- Presence of self-reported symptoms(within 36 months of follow-up)
- Presence of risk factors for infection during follow-up (assessment via custom questionnaire)(within 36 months of follow-up)
- Proportion of seropositive children reporting COVID-19 related symptoms from January 2020(at inclusion)
- Proportion of participants, seronegative at inclusion, with symptoms in the follow-up(within 36 months of follow-up)
- Presence of risk factors for infection at inclusion (assessment via custom questionnaire)(at inclusion)
- Self-reported mental well-being (KINDL questionnaire)(within 36 months of follow-up)
- Self-reported quality of life (KINDL questionnaire)(within 36 months of follow-up)
- Incidence of seropositive SARS-Cov-2 clusters in schools during the follow-up(within 36 months of follow-up)
- Self-reported lifestyle changes of participants during follow-up(within 36 months of follow-up)
研究者
Susi Kriemler
Prof. Dr. med.
University of Zurich