Evaluating COVID-19 booster effects in pregnant and breastfeeding women
Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
Thomas Jefferson University · NCT05543993
This study tests how a COVID-19 booster shot affects the immunity of pregnant and breastfeeding women and their babies against different COVID-19 variants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 13 Years to 55 Years |
| Sex | Female |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05543993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of COVID-19 mRNA booster vaccination on maternal and infant immunity against COVID-19 variants. It will enroll 100 pregnant women and 100 breastfeeding women who have received the booster, following them longitudinally for three months postpartum or three months post-enrollment for breastfeeding participants. Maternal blood, cord blood at delivery, breast milk, and infant samples will be collected to evaluate immune responses over time.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women or breastfeeding women who have received the mRNA bivalent COVID-19 booster.
Not a fit: Patients with multifetal gestation or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how COVID-19 vaccination affects immunity in mothers and infants, potentially leading to improved health outcomes.
How similar studies have performed: Other studies have explored the effects of COVID-19 vaccination during pregnancy and lactation, indicating a growing body of evidence in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Rupsa C Boelig, MD — Thomas Jefferson University
- Study coordinator: Brandy Firman
- Email: brandy.firman@jefferson.edu
- Phone: 215-586-1656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COVID-19, vaccine, COVID-19 vaccine, booster, pregnancy, breastfeeding, immunity