NCT05004740

Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Deborah O'Connor · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Vaccine
• Breastmilk

Interventions

Type	Name	Description
OTHER	Vaccinated Pregnant or Lactating persons	vaccinated lactating persons from Sinai Health System or the general public

Timeline

• Start date: 2021-01-17
• Primary completion: 2022-04-27
• Completion: 2023-04-27
• First posted: 2021-08-13
• Last updated: 2025-06-06

Locations

1 site across 1 country: Canada