Gestational Immunity for Transfer

NCT04802278 | Unknown

• 1 other identifier: 2021/00095
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study prospective cohort study at an urban academic centre, with two parts:

1. 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. 2.Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19

Conditions

Covid19; Breastfeeding; Vaccine Exposure Via Breast Milk

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• General health

  From birth to 12 months of age

Study Arms (3)

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

Interventions

COVID-19 vaccine BIOLOGICAL

Any COVID-19 vaccine

Vaccinated mothers

Eligibility Criteria

• Gender Eligibility Details: For group 3; only lactating women recruited
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Lives in Singapore

You may not qualify if:

• Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (2)

• Gu Y, Low JM, Tan JSY, Ng MSF, Ng LFP, Shunmuganathan B, Gupta R, MacAry PA, Amin Z, Lee LY, Lian D, Shek LP, Zhong Y, Wang LW. Immune and pathophysiologic profiling of antenatal coronavirus disease 2019 in the GIFT cohort: A Singaporean case-control study. Front Pediatr. 2022 Sep 15;10:949756. doi: 10.3389/fped.2022.949756. eCollection 2022.

  PMID: 36186648 DERIVED

• Low JM, Lee LY, Ng YPM, Zhong Y, Amin Z. Breastfeeding Mother and Child Clinical Outcomes After COVID-19 Vaccination. J Hum Lact. 2022 Feb;38(1):37-42. doi: 10.1177/08903344211056522. Epub 2021 Oct 29.

  PMID: 34713745 DERIVED

MeSH Terms

Conditions

COVID-19; Breast Feeding

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Jia Ming Low, MBBS, MCI

CONTACT

+65 6779 5555; jia_ming_low@nuhs.edu.sg

Youjia Zhong, MBChB, MCI

CONTACT

+65 6779 5555; youjia_zhong@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: May 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

SG (1)