Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c
1 other identifier
observational
78
1 country
1
Brief Summary
This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2021
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2023
CompletedJune 6, 2025
June 1, 2025
1.3 years
August 11, 2021
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination
Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination.
Study Arms (1)
Lactating birthing persons delivering at Sinai Health System or from the general population
Interventions
vaccinated lactating persons from Sinai Health System or the general public
Eligibility Criteria
Community sample
You may qualify if:
- lactating birthing persons from the general public or Sinai Health System
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deborah O'Connorlead
- University of Torontocollaborator
- Sinai Health Systemcollaborator
Study Sites (1)
Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
Related Publications (1)
Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14.
PMID: 38309831BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Scientist
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 13, 2021
Study Start
January 17, 2021
Primary Completion
April 27, 2022
Study Completion
April 27, 2023
Last Updated
June 6, 2025
Record last verified: 2025-06