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

• Sponsor: Deborah O'Connor (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05004740
• Collaborator: University of Toronto (Other), Sinai Health System (Other)
• Enrollment: 78
• Location: 1
• Anticipated Duration (Months): 16.4
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Vaccine; Breastmilk	Other: Vaccinated Pregnant or Lactating persons

Study Design

• Study Type: Observational
• Actual Enrollment: 78 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c
• Actual Study Start Date: Jan 17, 2021
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lactating birthing persons delivering at Sinai Health System or from the general population	Other: Vaccinated Pregnant or Lactating persons; vaccinated lactating persons from Sinai Health System or the general public

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinai Health System	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

• Deborah O'Connor
• University of Toronto
• Sinai Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah O'Connor, Scientist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT05004740
• Other Study ID Numbers: 39373-c
• First Posted: Aug 13, 2021
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 13, 2022