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Gestational Immunity for Transfer

Gestational Immunity for Transfer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04802278
Acronym
GIFT
Enrollment
120
Registered
2021-03-17
Start date
2020-05-01
Completion date
2021-12-01
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Covid19, Vaccine Exposure Via Breast Milk

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.

Interventions

BIOLOGICALCOVID-19 vaccine

Any COVID-19 vaccine

Sponsors

National University of Singapore
CollaboratorOTHER
Agency for Science, Technology and Research
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Lives in Singapore

Exclusion criteria

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Design outcomes

Primary

MeasureTime frameDescription
Transplacentally transferred antibodiesFrom birth to 12 months of ageBinding and neutralising immunoglobulin G specific to SARS-CoV-2 spike and receptor-binding domain
Antibodies transferred through breast milk (convalescent mothers)From birth to 6 months of ageBinding 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 vaccinationBinding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain

Secondary

MeasureTime frameDescription
General healthFrom birth to 12 months of ageGrowth and development of infants

Countries

Singapore

Contacts

Primary ContactJia Ming Low, MBBS, MCI
jia_ming_low@nuhs.edu.sg+65 6779 5555
Backup ContactYoujia Zhong, MBChB, MCI
youjia_zhong@nuhs.edu.sg+65 6779 5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026