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Purpose

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection. The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.

Conditions

Eligibility

Eligible Ages
Between 14 Years and 55 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

for Vaccine Arm: - All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy.

Exclusion Criteria

  • Prior COVID-19 infection. Inclusion Criteria for Sample Collection Arm: - All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment. - Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor & Delivery. Exclusion Criteria: - None

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Vaccine Arm Pregnant women who are planning to receive an mRNA COVID vaccine (Pfizer of Moderna), and/or a third booster vaccine, who consent to maternal blood collection before receipt of the vaccine and at 6 time points after receiving the vaccine and/or booster.
  • Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)
    mRNA vaccine received at any time during pregnancy course
    Other names:
    • Pfizer or Moderna COVID-19 vaccine
Sample Collection at Delivery Arm Pregnant patients who have tested positive for COVID during their pregnancy or have a positive COVID test at the time of admission to Labor & Delivery, who consent to collection of maternal blood, cord blood, placenta, and breast milk samples, as well as neonatal blood and stool samples. Patients testing negative for COVID at the time of admission to Labor & Delivery can be enrolled in the study as controls.

Recruiting Locations

Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
William C Golden, M.D..
410-955-4588
cgolden@jhmi.edu

More Details

NCT ID
NCT05197621
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

William C Golden, MD
410-955-4588
cgolden@jhmi.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.