COVID Booster in Pregnancy and Lactation

November 24, 2025 updated by: Rupsa C. Boelig, Thomas Jefferson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 booster in pregnancy
Pregnant singletons who have received COVID-19 booster in pregnancy
Drug: Bivalent COVID-19 Booster
Bivalent COVID-19 Booster by Pfizer or Moderna
COVID-19 booster in breastfeeding
Breastfeeding individuals who have received COVID-19 booster while breastfeeding
Drug: Bivalent COVID-19 Booster
Bivalent COVID-19 Booster by Pfizer or Moderna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Serological Profile
Time Frame: 3 months
Quantitative Maternal IgG to SARS CoV2 spike and other domains
3 months
Maternal Functional Immunity
Time Frame: 3 months
Quantitative Antibody neutralization capacity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant serological profile
Time Frame: 3 months old
Quantitative IgG to SARS CoV2
3 months old
Infant functional immunity
Time Frame: 3 months old
Quantitative Antibody neutralization capacity
3 months old
Breastmilk serological profile
Time Frame: 3 months
Quantitative IgA to SARS CoV2
3 months
Infant oral immunity
Time Frame: 3 months
Quantitative Salivary SARS CoV2 IgG
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Walter Reed Army Institute of Research (WRAIR)
Nemours Childrens Health

Investigators

  • Principal Investigator: Rupsa C Boelig, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22F.452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements

IPD Sharing Time Frame

Data will be available 12 months after publication of primary results and for up to 2 years

IPD Sharing Access Criteria

Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Bivalent COVID-19 Booster

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe