COVID Booster in Pregnancy and Lactation
Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedStudy Start
First participant enrolled
September 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedDecember 2, 2025
November 1, 2025
1.7 years
September 14, 2022
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maternal Serological Profile
Quantitative Maternal IgG to SARS CoV2 spike and other domains
3 months
Maternal Functional Immunity
Quantitative Antibody neutralization capacity
3 months
Secondary Outcomes (4)
Infant serological profile
3 months old
Infant functional immunity
3 months old
Breastmilk serological profile
3 months
Infant oral immunity
3 months
Study Arms (2)
COVID-19 booster in pregnancy
Pregnant singletons who have received COVID-19 booster in pregnancy
COVID-19 booster in breastfeeding
Breastfeeding individuals who have received COVID-19 booster while breastfeeding
Interventions
Bivalent COVID-19 Booster by Pfizer or Moderna
Eligibility Criteria
1. Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy 2. Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster
You may qualify if:
- Singleton gestation
- Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
You may not qualify if:
- Multifetal gestation
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Jefferson Universitylead
- Walter Reed Army Institute of Research (WRAIR)collaborator
- Nemours Childrens Healthcollaborator
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Biospecimen
Maternal blood Cord blood Breastmilk Infant blood Infant oral
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rupsa C Boelig, MD
Thomas Jefferson University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 16, 2022
Study Start
September 29, 2022
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available 12 months after publication of primary results and for up to 2 years
- Access Criteria
- Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements
Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements