Breastmilk, COVID-19 Vaccine
Conditions
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.
Interventions
OTHERVaccinated Pregnant or Lactating persons
vaccinated lactating persons from Sinai Health System or the general public
Sponsors
University of Toronto
Sinai Health System
Deborah O'Connor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* lactating birthing persons from the general public or Sinai Health System
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Canada
Outcome results
None listed