NCT05543993

COVID Booster in Pregnancy and Lactation

Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 13 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Bivalent COVID-19 Booster	Bivalent COVID-19 Booster by Pfizer or Moderna

Timeline

• Start date: 2022-09-29
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2022-09-16
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study