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.
Study Type
OBSERVATIONAL
Enrollment
300
mRNA vaccine received at any time during pregnancy course
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGEvaluation 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 collection
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 collection
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 collection
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 collection
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