Gestational Immunity for Transfer

Covid19 Clinical Trial

— GIFT  

Official title:

Gestational Immunity for Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802278
• Other study ID #: 2021/00095
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: National University Hospital, Singapore
• Contact: Jia Ming Low, MBBS, MCI
• Phone: +65 6779 5555
• Email: jia_ming_low[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Lives in Singapore

Exclusion Criteria:

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Related Conditions & MeSH terms

• Breastfeeding
• Covid19
• Vaccine Exposure Via Breast Milk

Intervention

Biological:
• COVID-19 vaccine
Any COVID-19 vaccine

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Agency for Science, Technology and Research, National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	General health	Growth and development of infants	From birth to 12 months of age