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OpenTrials
Completed

NCT Number: NCT05004740

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lactating birthing persons from the general public or Sinai Health System

Exclusion criteria

  • None

Treatment and study plan

Vaccinated Pregnant or Lactating persons

Other

vaccinated lactating persons from Sinai Health System or the general public

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Deborah O'Connor

Other

Collaborators

  • Sinai Health System
  • University of Toronto

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 13, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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