Gestational Immunity for Transfer

• Conditions: Breastfeeding; Vaccine Exposure Via Breast Milk; Covid19
• Interventions: Biological: COVID-19 vaccine

• Registration Number: NCT04802278
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

This is a study prospective cohort study at an urban academic centre, with two parts:

1. Health outcomes, and maternally transferred antibodies, in babies born to mothers who had antenatal COVID-19 and convalesced before delivery, followed up until 12 months of age

2. Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19

Detailed Description

This proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of COVID-19.

We first recruit all babies delivered to mothers convalescent from antenatal COVID-19, to 1) follow up their growth and development, and 2) study the protective effects of antibodies transferred from mother to child transplacentally during pregnancy, as well as postnatally through breastfeeding. We compare these to a cohort of healthy controls whose mothers did not have COVID-19 during pregnancy.

Next, we compare the protective effects of antibodies transferred during breastfeeding from mother to child after lactating mothers are vaccinated against COVID-19, to that of natural infection. We also study the safety of breastfeeding after vaccination by looking for vaccine components in the breast milk.

Study Timeline

• Study Start: 2020-05-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Lives in Singapore

Exclusion Criteria

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated mothers	COVID-19 vaccine	Lactating mothers who received COVID-19 vaccination

Primary Outcome Measures

Name	Time	Method
Antibodies transferred through breast milk (convalescent mothers)	From birth to 6 months of age	Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Antibodies transferred through breast milk (vaccinated mothers)	From just before vaccination, to 6 weeks after vaccination	Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Transplacentally transferred antibodies	From birth to 12 months of age	Binding and neutralising immunoglobulin G specific to SARS-CoV-2 spike and receptor-binding domain

Secondary Outcome Measures

Name	Time	Method
General health	From birth to 12 months of age	Growth and development of infants

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore