Passive Transmission of COVID-19 Antibody From Mother to Infant

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: Passive Transmission of Maternal and Infant Antibodies
• Intervention / Treatment: Biological: sars-cov-2 vaccine or infection

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Yuting Yang, Ms; Phone Number: 18990304808; Email: 412384223@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Yuting Yang
      • Contact: Yuting Yang; Phone Number: 18990304808; Email: 412384223@qq.com

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

4

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	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	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

• Sponsor: Children's Hospital of Chongqing Medical University

Study record dates

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