COVID Booster in Pregnancy and Lactation
Purpose
This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 13 Years and 55 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Singleton gestation - Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
Exclusion Criteria
- Multifetal gestation - Unable to provide consent
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| COVID-19 booster in pregnancy | Pregnant singletons who have received COVID-19 booster in pregnancy |
|
| COVID-19 booster in breastfeeding | Breastfeeding individuals who have received COVID-19 booster while breastfeeding |
|
Recruiting Locations
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
More Details
- NCT ID
- NCT05543993
- Status
- Recruiting
- Sponsor
- Thomas Jefferson University
Detailed Description
We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.