Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 5:45 AM
Study NCT ID:
NCT05543993
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID Booster in Pregnancy and Lactation
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: