Gestational Immunity for Transfer (GIFT)

March 15, 2021 updated by: National University Hospital, Singapore

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Part 1 of study - infants Part 2 of study - lactating women

Description

Inclusion Criteria:

Lives in Singapore

Exclusion Criteria:

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Babies born to mothers convalescent from antenatal COVID-19
Babies born to healthy mothers
Vaccinated mothers
Lactating mothers who received COVID-19 vaccination
Biological: COVID-19 vaccine
Any COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplacentally transferred antibodies
Time Frame: From birth to 12 months of age
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)
Time Frame: From birth to 6 months of age
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)
Time Frame: From just before vaccination, to 6 weeks after vaccination
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
Time Frame: From birth to 12 months of age
Growth and development of infants
From birth to 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Agency for Science, Technology and Research
National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/00095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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