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NCT05543993 Clinical Trial

COVID Booster in Pregnancy and Lactation

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05543993
Other study ID # 22F.452
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2022
Est. completion date March 1, 2025

Study information
Verified date April 2024
Source Thomas Jefferson University
Contact Brandy Firman
Phone 215-586-1656
Email brandy.firman@jefferson.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date March 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Bivalent COVID-19 Booster
Bivalent COVID-19 Booster by Pfizer or Moderna

Locations
Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (3)
Lead Sponsor Collaborator
Thomas Jefferson University Nemours Childrens Health, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal Serological Profile Quantitative Maternal IgG to SARS CoV2 spike and other domains 3 months
Primary Maternal Functional Immunity Quantitative Antibody neutralization capacity 3 months
Secondary Infant serological profile Quantitative IgG to SARS CoV2 3 months old
Secondary Infant functional immunity Quantitative Antibody neutralization capacity 3 months old
Secondary Breastmilk serological profile Quantitative IgA to SARS CoV2 3 months
Secondary Infant oral immunity Quantitative Salivary SARS CoV2 IgG 3 months
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