The Impact of COVID-19 on Maternal and Neonatal Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- mRNA COVID-19 vaccine (Pfizer or Moderna)
- Conditions
- COVID-19
- Sponsor
- Johns Hopkins University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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:
Arms & Interventions
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.
Intervention: mRNA COVID-19 vaccine (Pfizer or Moderna)
Outcomes
Primary Outcomes
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
Time Frame: 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 Outcomes
- 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)
- 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)