COVID Booster in Pregnancy and Lactation

NCT ID: NCT05543993

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-29

Study Completion Date

2024-06-10

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 booster in pregnancy

Pregnant singletons who have received COVID-19 booster in pregnancy

Bivalent COVID-19 Booster

Intervention Type DRUG

Bivalent COVID-19 Booster by Pfizer or Moderna

COVID-19 booster in breastfeeding

Breastfeeding individuals who have received COVID-19 booster while breastfeeding

Bivalent COVID-19 Booster

Intervention Type DRUG

Bivalent COVID-19 Booster by Pfizer or Moderna

Interventions

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Bivalent COVID-19 Booster

Bivalent COVID-19 Booster by Pfizer or Moderna

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Multifetal gestation
* Unable to provide consent
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role collaborator

Nemours Childrens Health

UNKNOWN

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Rupsa C. Boelig

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rupsa C Boelig, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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22F.452

Identifier Type: -

Identifier Source: org_study_id

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