Clinical trial NCT04802278: Gestational Immunity for Transfer
Official title: Gestational Immunity for Transfer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Breastfeeding
Vaccine Exposure Via Breast Milk
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: Agency for Science, Technology and Research
First posted: 2021-03-17
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Part 1 of study - infants Part 2 of study - lactating women

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.

Eligibility criteria: Inclusion Criteria:

Lives in Singapore

Exclusion Criteria:

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders

Primary outcomes:
measure: Transplacentally transferred antibodies
timeFrame: From birth to 12 months of age
measure: Antibodies transferred through breast milk (convalescent mothers)
timeFrame: From birth to 6 months of age
measure: Antibodies transferred through breast milk (vaccinated mothers)
timeFrame: From just before vaccination, to 6 weeks after vaccination
Secondary outcomes:
measure: General health
timeFrame: From birth to 12 months of age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: 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.
citation: 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.