Passive Transmission of COVID-19 Antibody From Mother to Infant

July 3, 2023 updated by: yuting yang, Children's Hospital of Chongqing Medical University

Children's Hospital of Chongqing Medical University

At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children; This will lay a foundation for further exploring the risk of COVID-19 infection in children and formulating immune prevention strategies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Recruiting
        • Yuting Yang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Samples of infants not infected with COVID-19 and not vaccinated with COVID-19 vaccine

Description

Inclusion Criteria:

  1. Children aged 0-2;
  2. No history of blood transfusion, chemotherapy, or related immunosuppressive therapy; No immune system related diseases;

Exclusion Criteria:

Not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group 1
Mother not vaccinated with COVID-19 vaccine
Biological: sars-cov-2 vaccine or infection
Whether to vaccinate COVID-19 vaccine, or infect with sars-cov-2
Control group 2
The mother was vaccinated with COVID-19 vaccine before pregnancy, and was not infected during pregnancy
Biological: sars-cov-2 vaccine or infection
Whether to vaccinate COVID-19 vaccine, or infect with sars-cov-2
Control group 3
The mother was vaccinated with COVID-19 vaccine before pregnancy, and was infected during pregnancy
Biological: sars-cov-2 vaccine or infection
Whether to vaccinate COVID-19 vaccine, or infect with sars-cov-2
Experimental group
The mother was not vaccinated with COVID-19 vaccine before pregnancy, so she was infected during pregnancy
Biological: sars-cov-2 vaccine or infection
Whether to vaccinate COVID-19 vaccine, or infect with sars-cov-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 IgG
Time Frame: duration of time over which each participant could be 6-month to 12-month
ELISA detection of SARS-CoV-2 IgG antibody levels
duration of time over which each participant could be 6-month to 12-month
SARS-CoV-2 neutralizing antibody
Time Frame: duration of time over which each participant could be 6-month to 12-month
detection the level of SARS-CoV-2 neutralizing antibody
duration of time over which each participant could be 6-month to 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

June 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Contact the project leader

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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