COVID Booster in Pregnancy and Lactation

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05543993
• Collaborator: Walter Reed Army Institute of Research (WRAIR) (U.S. Fed), Nemours Childrens Health System (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Bivalent COVID-19 Booster

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	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 breasfeeding	Drug: Bivalent COVID-19 Booster; Bivalent COVID-19 Booster by Pfizer or Moderna

Outcome Measures

Primary Outcome Measures

1. Maternal Serological Profile [3 months]

   Maternal IgG to SARS CoV2 spike and other domains

2. Maternal Functional Immunity [3 months]

   Antibody neutralization capacity

Secondary Outcome Measures

1. Infant serological profile [3 months old]

   IgG to SARS CoV2

2. Infant functional immunity [3 months old]

   Antibody neutralization capacity

3. Breastmilk serological profile [3 months]

   IgA to SARS CoV2

4. Infant oral immunity [3 months]

   Salivary SARS CoV2 IgG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Singleton gestation

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

Exclusion Criteria:

• Multifetal gestation

• Unable to provide consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University
• Walter Reed Army Institute of Research (WRAIR)
• Nemours Childrens Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT05543993
• Other Study ID Numbers: 22F.452
• First Posted: Sep 16, 2022
• Last Update Posted: Sep 16, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Thomas Jefferson University: vaccine; COVID-19 vaccine; booster; pregnancy; breastfeeding; immunity
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 16, 2022