The Impact of COVID-19 on Maternal and Neonatal Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age14-55
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Prior COVID-19 infection.
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.
None
Trial population
All pregnant women, aged 14-55, receiving prenatal care from 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, or, patients who have had a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
mRNA COVID-19 vaccine (Pfizer or Moderna)
Biological/VaccinemRNA vaccine received at any time during pregnancy course
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Vaccine Arm1 intervention
Group B: Sample Collection at Delivery Arm0 interventions
Trial outcomes
Primary outcomes
1
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
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.
Time frame
Testing will be performed from the time of study enrollment up to one year after sample collectionSecondary outcomes
1
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
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).
Time frame
Testing will be performed from the time of study enrollment up to one year after sample collection2
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
Identification of T cell 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).
Time frame
Testing will be performed from the time of study enrollment up to one year after sample collection3
To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people
Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity.
Time frame
Testing will be performed from the time of study enrollment up to one year after sample collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Integrated Research Center for Fetal Medicine
Collaborator
Source ClinicalTrials.gov