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

Active, not recruiting

• Conditions: COVID-19 Vaccine; Breastmilk
• Interventions: Other: Vaccinated Pregnant or Lactating persons

• Registration Number: NCT05004740
• Lead Sponsor: Deborah O'Connor

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-17
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-13
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lactating birthing persons delivering at Sinai Health System or from the general population	Vaccinated Pregnant or Lactating persons	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sinai Health System; 🇨🇦 Toronto, Ontario, Canada