COVID Booster in Pregnancy and Lactation | NCT05543993

Studies
COVID Booster in Pregnancy and Lactation

NCT05543993

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Dec 2, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Bivalent COVID-19 Booster

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2022Actual

Primary Completion Date

Jun 10, 2024Actual

Completion Date

Jun 10, 2024Actual

First Submitted Date

Sep 14, 2022

First Submission Date that Met QC Criteria

Sep 14, 2022

First Posted Date

Sep 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rupsa C. Boelig, Assistant Professor, Thomas Jefferson UniversityPrincipal Investigator

Lead Sponsor

Thomas Jefferson UniversityOTHER

Collaborators

Name	Class
Walter Reed Army Institute of Research (WRAIR)	FED
Nemours Childrens Health	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 booster in pregnancy		Pregnant singletons who have received COVID-19 booster in pregnancy	Drug: Bivalent COVID-19 Booster
COVID-19 booster in breastfeeding		Breastfeeding individuals who have received COVID-19 booster while breastfeeding	Drug: Bivalent COVID-19 Booster

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bivalent COVID-19 Booster	Drug	Bivalent COVID-19 Booster by Pfizer or Moderna	COVID-19 booster in breastfeeding COVID-19 booster in pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Infant serological profile	Quantitative IgG to SARS CoV2	3 months old
Infant functional immunity	Quantitative Antibody neutralization capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton gestation
Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding

Exclusion Criteria:

Multifetal gestation
Unable to provide consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy
Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupsa C Boelig, MD	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University Hospital		Philadelphia	Pennsylvania	19107	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D001942	Breast Feeding

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

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Browse Branches

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