Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children

Study Overview
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Brief Summary
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It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions. The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children

Detailed Description
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Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.

Official Title
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Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2 IgG Antibody testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤ 18 years old. Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19 Have not been previously diagnosed and are presumed/confirmed COVID-19 negative Have blood specimens collected for any routine biochemistry test on the date enrollment Exclusion Criteria: Refusal to participate in this study.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SARS-CoV-2 IgG Antibody testing|IgG Antibody testing for previous exposure to SARS-CoV-2|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of children with IgG SARS-CoV-2 antibodies in Plasma | The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study | 6 month | 
| Immunoglobulins (G) to SARS-CoV-2 in plasma | Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of association between SARS-CoV-2 IgG seropositivity and characteristics | socio-demographics, previous exposure to SARS-CoV-2 | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Seroprevalence, IgG Antibodies, Children, Vietnam, Covid-19