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

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

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).

Recruiting
Severe Acute Respiratory Syndrome

Other: Diagnostic test

Presence of antibodies in saliva

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 1 Year ~ Maximum: 18 Years
Countries
Germany
Locations

Institute of Tropical Medicine
Tübingen, Deutschland, Germany

Investigator: Yudi Tatiana Röckl-Pinilla, Dr.
Contact: +49070712844311
tatiana.roeckl-pinilla@uni-tuebingen.de

Investigator:

Contacts

Yudi Tatiana Röckl-Pinilla, Dr.
01762844311
tatiana.roeckl-pinilla@uni-tuebingen.de

Andrea Kreidenweiss, Dr.
+4907071 2985569
andrea.kreidenweiss@uni-tuebingen.de@uni-tuebingen.de

University Hospital Tuebingen
NCT Number
Keywords
SARS-CoV-2
Antibodies
Saliva
Children
Epidemiology
MeSH Terms
Severe Acute Respiratory Syndrome