NCT05197621 is a clinical trial of mRNA COVID-19 vaccine (Pfizer or Moderna) in COVID-19, sponsored by Johns Hopkins University.

Who is sponsoring NCT05197621?

NCT05197621 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT05197621?

Interventions in NCT05197621: mRNA COVID-19 vaccine (Pfizer or Moderna).

What condition does NCT05197621 study?

NCT05197621 studies COVID-19, Pregnancy; Infection.

Is NCT05197621 still recruiting?

NCT05197621 is currently recruiting now. Last updated 9 May 2025.

Last reviewed 2025-05-09 · How we verify

NCT05197621

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Impact of COVID-19 on Maternal and Neonatal Outcomes

Recruiting now Last updated 9 May 2025

What this trial tests

trial testing mRNA COVID-19 vaccine (Pfizer or Moderna) in COVID-19 in 300 participants. Currently enrolling.

Timeline

13 April 2020

Primary endpoint
5 May 2027

5 May 2028

Quick facts

Lead sponsor	Johns Hopkins University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	300
Start date	13 April 2020
Primary completion	5 May 2027
Estimated completion	5 May 2028
Sites	1 location across United States

Drugs / interventions tested

mRNA COVID-19 vaccine (Pfizer or Moderna) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →
Pregnancy; Infection — all drugs for Pregnancy; Infection →

Sponsor

Johns Hopkins University

Who can join

Adults 14 to 55, female only, with COVID-19 or Pregnancy; Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Associations of COVID-19 vaccination during pregnancy with adverse neonatal and maternal outcomes: A systematic review and meta-analysis.
Ding C, Liu Y, Pang W, Zhang D, et al · · 2023 · cited 17× · PMID 36794075 · DOI 10.3389/fpubh.2023.1044031
Messenger RNA Therapy for Female Reproductive Health.
VanKeulen-Miller R, Fenton OS. · · 2024 · cited 11× · PMID 38189262 · DOI 10.1021/acs.molpharmaceut.3c00803

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05197621 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 9 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05197621.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing