COVID-19, Pregnancy; Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALmRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course
Sponsors
Johns Hopkins University
Integrated Research Center for Fetal Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy | Testing will be performed from the time of study enrollment up to one year after sample collection | Evaluation of biospecimens (maternal \& neonatal blood, cord blood, placenta samples, neonatal stool samples \& breast milk) collected from recently delivered pregnant women and neonates for biomarkers of placental inflammation and early onset neonatal sepsis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people | Testing will be performed from the time of study enrollment up to one year after sample collection | Investigation of antibody responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations). |
| To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people | Testing will be performed from the time of study enrollment up to one year after sample collection | Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity. |
Countries
United States
Contacts
CONTACTWilliam C Golden, MD
CONTACTKimberly Jones-Beatty, DNP, CNM
PRINCIPAL_INVESTIGATORWilliam C Golden, MD
Johns Hopkins University
Outcome results
None listed