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

NCT05004740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2025-06-06

No results posted yet for this study

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

OTHER

Vaccinated Pregnant or Lactating persons

vaccinated lactating persons from Sinai Health System or the general public

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Sinai Health System

    collaborator OTHER

  • Deborah O'Connor

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-17
Primary Completion
2022-04-27
Completion
2023-04-27

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004740 on ClinicalTrials.gov