COVID Booster in Pregnancy and Lactation

Recruiting

• Conditions: COVID-19
• Interventions: Drug: Bivalent COVID-19 Booster

• Registration Number: NCT05543993
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2022-09-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 booster in breastfeeding	Bivalent COVID-19 Booster	Breastfeeding individuals who have received COVID-19 booster while breastfeeding
COVID-19 booster in pregnancy	Bivalent COVID-19 Booster	Pregnant singletons who have received COVID-19 booster in pregnancy

Primary Outcome Measures

Name	Time	Method
Maternal Serological Profile	3 months	Quantitative Maternal IgG to SARS CoV2 spike and other domains
Maternal Functional Immunity	3 months	Quantitative Antibody neutralization capacity

Secondary Outcome Measures

Name	Time	Method
Infant serological profile	3 months old	Quantitative IgG to SARS CoV2
Infant functional immunity	3 months old	Quantitative Antibody neutralization capacity
Breastmilk serological profile	3 months	Quantitative IgA to SARS CoV2
Infant oral immunity	3 months	Quantitative Salivary SARS CoV2 IgG

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States