Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05197621

Conditions

COVID-19

Pregnancy; Infection

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

Interventions

mRNA COVID-19 vaccine (Pfizer or Moderna)

Study Details

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.

Conditions

COVID-19

Pregnancy; Infection

Study ID

NCT05197621

Start date

Apr 13, 2020

Status verified date

May, 2026

Completion date

May 5, 2028

Anticipated

Primary completion date

May 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Sample Collection at Delivery Arm

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.

Interventions

mRNA COVID-19 vaccine (Pfizer or Moderna)

mRNA vaccine received at any time during pregnancy course

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

William C Golden, MD

410-955-4588cgolden@jhmi.edu

Kimberly Jones-Beatty, DNP, CNM

kjone111@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

William C Golden, M.D..

410-955-4588cgolden@jhmi.edu

Kimberly Jones-Beatty, DNP, CNM

kjone111@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-11.