Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c
June 3, 2025 updated by: Deborah O'Connor
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Sinai Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- lactating birthing persons from the general public or Sinai Health System
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lactating birthing persons delivering at Sinai Health System or from the general population
|
vaccinated lactating persons from Sinai Health System or the general public
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination
Time Frame: Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination.
|
Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2021
Primary Completion (Actual)
April 27, 2022
Study Completion (Actual)
April 27, 2023
Study Registration Dates
First Submitted
August 11, 2021
First Submitted That Met QC Criteria
August 11, 2021
First Posted (Actual)
August 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 6, 2025
Last Update Submitted That Met QC Criteria
June 3, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39373-c
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.