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

Sponsor
National Children's Hospital, Vietnam (Other)
Overall Status
Recruiting
CT.gov ID
NCT05358626
Collaborator
(none)
4,500
1
6
744.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SARS-CoV-2 IgG Antibody testing

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 Design

Study Type:
Observational
Anticipated Enrollment :
4500 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam
Actual Study Start Date :
Mar 13, 2022
Anticipated Primary Completion Date :
Jun 5, 2022
Anticipated Study Completion Date :
Sep 13, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Immunoglobulins (G) to SARS-CoV-2 in plasma [6 month]

    Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays

Secondary Outcome Measures

  1. Measure of association between SARS-CoV-2 IgG seropositivity and characteristics [6 month]

    socio-demographics, previous exposure to SARS-CoV-2

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vietnam National Children's Hospital Hanoi Vietnam

Sponsors and Collaborators

  • National Children's Hospital, Vietnam

Investigators

  • Principal Investigator: Phuc H Phan, MD, Vietnam National Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Phuc Huu Phan, Physician, National Children's Hospital, Vietnam
ClinicalTrials.gov Identifier:
NCT05358626
Other Study ID Numbers:
  • ChildrensHVietnam
First Posted:
May 3, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Phuc Huu Phan, Physician, National Children's Hospital, Vietnam
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022