Gestational Immunity for Transfer

Study Overview
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Brief Summary
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This is a study prospective cohort study at an urban academic centre, with two parts: 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 Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19

Detailed Description
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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.

Official Title
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Gestational Immunity for Transfer

Conditions
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Covid19, Breastfeeding, Vaccine Exposure Via Breast Milk

Intervention / Treatment
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* Biological: COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lives in Singapore Exclusion Criteria: Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Babies born to mothers convalescent from antenatal COVID-19<br> | |
| Babies born to healthy mothers<br> | |
| Vaccinated mothers<br>Lactating mothers who received COVID-19 vaccination | Biological: COVID-19 vaccine<br>* Any COVID-19 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health | Growth and development of infants | From birth to 12 months of age |