Severe Acute Respiratory Syndrome
Conditions
Keywords
SARS-CoV-2, antibodies, saliva, children, epidemiology
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).
Interventions
OTHERDiagnostic test
Presence of antibodies in saliva
Sponsors
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SARS-CoV-2 infection in infants, children and adolescents | 12 months | Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SARS-CoV-2 | 12 months | Change of incidence of SARS-CoV-2 infection in children during 2020/2021 |
Other
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 antibody persistence | 12 months | SARS-CoV-2 antibodies persistence in peripheral blood and saliva |
| Antibodies presence in saliva samples | 18 months | Saliva samples as alternative for the detection of antibodies against SARS-CoV-2 |
Countries
Germany
Outcome results
None listed