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Gestational Immunity for Transfer (GIFT)

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ClinicalTrials.gov Identifier: NCT04802278
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
National University, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
National University Hospital, Singapore

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

Condition or disease Intervention/treatment
Covid19 Breastfeeding Vaccine Exposure Via Breast Milk Biological: COVID-19 vaccine

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gestational Immunity for Transfer
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. General health [ Time Frame: From birth to 12 months of age ]
    Growth and development of infants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   For group 3; only lactating women recruited
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Part 1 of study - infants Part 2 of study - lactating women
Criteria

Inclusion Criteria:

Lives in Singapore

Exclusion Criteria:

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802278


Contacts
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Contact: Jia Ming Low, MBBS, MCI +65 6779 5555 jia_ming_low@nuhs.edu.sg
Contact: Youjia Zhong, MBChB, MCI +65 6779 5555 youjia_zhong@nuhs.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Jia Ming Low, MBBS, MCI       jia_ming_low@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Agency for Science, Technology and Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT04802278    
Other Study ID Numbers: 2021/00095
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No