Pinilla Yudi T, Friessinger Evelyn, Griesbaum Johanna Marie, Berner Lilith, Heinzel Constanze, Elsner Käthe, Fendel Rolf, Held Jana, Kreidenweiss Andrea
Institut für Tropenmedizin, Universitätsklinikum Tübingen, Tübingen, Germany.
Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
JMIR Res Protoc. 2021 Oct 8;10(10):e27739. doi: 10.2196/27739.
The world has been confronted with the COVID-19 pandemic for more than one year. Severe disease is more often found among elderly people, whereas most young children and adolescents show mild symptoms or even remain asymptomatic, so that infection might be undiagnosed. Therefore, only limited epidemiological data on SARS-CoV-2 infection in children and young adults are available.
This study aims to determine the prevalence of SARS-CoV-2 antibodies in children from the city of Tübingen, Germany, and to measure the incidence of new cases over 12 months.
SARS-CoV-2 antibodies will be measured in saliva as a surrogate for a previous SARS-CoV-2 infection. Children will be sampled at their preschools, primary schools, and secondary schools at three time points: July 2020, October to December 2020, and April to July 2021. An adult cohort will be sampled at the same time points (ie, adult comparator group). The saliva-based SARS-CoV-2-antibody enzyme-linked immunosorbent assay will be validated using blood and saliva samples from adults with confirmed previous SARS-CoV-2 infections (ie, adult validation group).
The first study participant was enrolled in July 2020, and recruitment and enrollment continued until July 2021. We have recruited and enrolled 1850 children, 560 adults for the comparator group, and 83 adults for the validation group. We have collected samples from the children and the adults for the comparator group at the three time points. We followed up with participants in the adult validation group every 2 months and, as of the writing of this paper, we were at time point 7. We will conduct data analysis after the data collection period.
Infection rates in children are commonly underreported due to a lack of polymerase chain reaction testing. This study will report on the prevalence of SARS-CoV-2 infections in infants, school children, and adolescents as well as the incidence change over 12 months in the city of Tübingen, Germany. The saliva sampling approach for SARS-CoV-2-antibody measurement allows for a unique, representative, population-based sample collection process.
ClinicalTrials.gov NCT04581889; https://clinicaltrials.gov/ct2/show/NCT04581889.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27739.
全球面临新冠疫情已逾一年。重症病例多见于老年人，而大多数幼儿及青少年症状轻微甚至无症状，感染可能未被诊断。因此，关于儿童和青年人群中新冠病毒感染的流行病学数据有限。
本研究旨在确定德国图宾根市儿童新冠病毒抗体的流行率，并测量12个月内新发病例的发生率。
将检测唾液中的新冠病毒抗体，作为既往感染新冠病毒的替代指标。在2020年7月、2020年10月至12月以及2021年4月至7月这三个时间点，对幼儿园、小学和中学的儿童进行采样。同时对成人队列进行采样（即成人对照组）。将使用既往确诊感染新冠病毒的成人的血液和唾液样本（即成人验证组），对基于唾液的新冠病毒抗体酶联免疫吸附测定进行验证。
2020年7月招募了首位研究参与者，招募工作持续至2021年7月。我们招募了1850名儿童、560名成人作为对照组以及83名成人作为验证组。我们在三个时间点收集了儿童和对照组成人的样本。我们每2个月对成人验证组的参与者进行随访，截至本文撰写时，我们处于第7个时间点。数据收集期结束后将进行数据分析。
由于缺乏聚合酶链反应检测，儿童感染率通常报告不足。本研究将报告德国图宾根市婴儿、学龄儿童和青少年中新冠病毒感染的流行率以及12个月内的发病率变化。用于测量新冠病毒抗体的唾液采样方法允许进行独特的、具有代表性的、基于人群的样本采集过程。
ClinicalTrials.gov NCT04581889；https://clinicaltrials.gov/ct2/show/NCT04581889。
国际注册报告识别码（IRRID）：DERR1-10.2196/27739。
