COVID Booster in Pregnancy and Lactation

Thomas Jefferson University

Status: Enrolling

Conditions: COVID-19

Treatments: Drug: Bivalent COVID-19 Booster

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05543993

22F.452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 13 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton gestation
• Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding

Exclusion criteria

• Multifetal gestation
• Unable to provide consent

Trial design

200 participants in 2 patient groups

COVID-19 booster in pregnancy

Description:

Pregnant singletons who have received COVID-19 booster in pregnancy

Treatment:

Drug: Bivalent COVID-19 Booster

COVID-19 booster in breastfeeding

Description:

Breastfeeding individuals who have received COVID-19 booster while breastfeeding

Treatment:

Drug: Bivalent COVID-19 Booster