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

Completed

• Conditions: COVID-19

• Registration Number: NCT05358626
• Lead Sponsor: National Children's Hospital, Vietnam

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-03-13
• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-03
• Primary Completion: 2022-06-05
• Study Completion: 2022-11-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4032

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measure of association between SARS-CoV-2 IgG seropositivity and characteristics	6 month	socio-demographics, previous exposure to SARS-CoV-2

Trial Locations

Locations (1)

Vietnam National Children's Hospital; 🇻🇳 Hanoi, Vietnam