Prevalence of Antibodies Against SARS-CoV-2 Virus That Causes COVID-19 in Tübingen Children

Study Overview
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Brief Summary
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This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.

Detailed Description
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The world is confronting Coronavirus Disease-2019 (COVID-19) pandemic caused by SARS-CoV-2 virus, which is causing many deaths and burden on intensive care facilities. Data regarding epidemiologic characteristics in children and young adults is limited, especially in the context of educational settings. Due to mild symptoms or even asymptomatic cases in children, the rate of SARS-CoV-2 infected children is underestimated. Therefore, the present study aims to determine the incidence of SARS-CoV-2 infection in children at 3 timepoints during 12 months expressed as seroconversion measured in non-invasive saliva sampling in Tübingen, a defined study area. Children and adolescents (N = 1850) in the age of 1 to 17 years will be recruited via child-care, kindergarten and primary and secondary schools and followed-up for 12 months: shortly after release of lock-down measures in summer 2020, before winter and after the winter. An adult cohort (adult comparator group) is sampled at the same time points for incidence comparisons. To validate the ELISA for SARS-CoV-2 antibody measurements in saliva compared to blood, and to understand the half-life of SARS-CoV-2 antibodies in respective body fluids, peripheral blood and in saliva will be sampled every 2 months in an additional adult group (adult validation group).

Official Title
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Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance

Conditions
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Severe Acute Respiratory Syndrome

Intervention / Treatment
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* Other: Diagnostic test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 1 months to 18 years Written informed consent of the parent/legal guardian (study population is minor) Written assent when children are ≥ 12 years Enrolled in a kita, kindergarden, primary, or secondary school located in Tübingen Adult population: Individuals >18 years who recovered from a confirmed SARS-CoV-2 infection. Or individuals > 18 years with an unknown status of previous SARS-CoV-2 infection Exclusion Criteria: Unwilling to give consent

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children from1 to 18 years, enrolled in kindergartens, primary, or secondary school located in city of Tübingen, Germany. | Other: Diagnostic test<br>* Presence of antibodies in saliva<br>|
| Adult comparator<br>Adults of unknown status of previous SARSCoV-2 infection. | |
| Adult validation<br>Adults who report a history of SARS-CoV-2 infections between 1. February 2020 and the time point of sampling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARS-CoV-2 infection in infants, children and adolescents | Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARS-CoV-2 | Change of incidence of SARS-CoV-2 infection in children during 2020/2021 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, antibodies, saliva, children, epidemiology