COVID Booster in Pregnancy and Lactation

Last updated: April 15, 2024
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

Bivalent COVID-19 Booster

Clinical Study ID

NCT05543993
22F.452
  • Ages 13-55
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Multifetal gestation
  • Unable to provide consent

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Bivalent COVID-19 Booster
Phase:
Study Start date:
September 29, 2022
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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