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Gestational Immunity for Transfer (GIFT)

N

National University Health System (NUHS)

Status

Unknown

Conditions

Vaccine Exposure Via Breast Milk
Breastfeeding
Covid19

Treatments

Biological: COVID-19 vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT04802278
2021/00095

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Lives in Singapore

Exclusion criteria

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Trial design

120 participants in 3 patient groups

Babies born to mothers convalescent from antenatal COVID-19
Babies born to healthy mothers
Vaccinated mothers
Description:
Lactating mothers who received COVID-19 vaccination
Treatment:
Biological: COVID-19 vaccine

Trial contacts and locations

1

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Central trial contact

Youjia Zhong, MBChB, MCI; Jia Ming Low, MBBS, MCI

Data sourced from clinicaltrials.gov

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