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The Impact of COVID-19 on Maternal and Neonatal Outcomes

Recruiting
Conditions
Pregnancy; Infection
COVID-19
Interventions
Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)
Registration Number
NCT05197621
Lead Sponsor
Johns Hopkins University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
300
Inclusion Criteria

Not provided

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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Vaccine ArmmRNA COVID-19 vaccine (Pfizer or Moderna)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.
Primary Outcome Measures
NameTimeMethod
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancyTesting 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 Outcome Measures
NameTimeMethod
To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating peopleTesting 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.

To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating peopleTesting will be performed from the time of study enrollment up to one year after sample collection

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).

Trial Locations

Locations (1)

Johns Hopkins Hospital

πŸ‡ΊπŸ‡Έ

Baltimore, Maryland, United States

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