The Impact of COVID-19 on Maternal and Neonatal Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of COVID-19 on Maternal and Neonatal Outcomes

Conditions
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COVID-19, Pregnancy; Infection

Intervention / Treatment
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* Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccine Arm<br>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. | Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)<br>* mRNA vaccine received at any time during pregnancy course<br>* Other names: Pfizer or Moderna COVID-19 vaccine;|
| Sample Collection at Delivery Arm<br>Pregnant patients who have tested positive for COVID during their pregnancy or have a positive COVID test at the time of admission to Labor & Delivery, who consent to collection of maternal blood, cord blood, placenta, and breast milk samples, as well as neonatal blood and stool samples. Patients testing negative for COVID at the time of admission to Labor & Delivery can be enrolled in the study as controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Testing will be performed from the time of study enrollment up to one year after sample collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | Testing will be performed from the time of study enrollment up to one year after sample collection |