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Woodruff Health Sciences Center, Emory University | July 14, 2020 | PRESS RELEASE
An investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) was generally well tolerated and resulted in production of both binding and neutralizing antibodies in healthy adult volunteers, according to interim results of an ongoing phase 1 trial published today in the New England Journal of Medicine.
The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured by Moderna, mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells.
Emory University’s Vaccine and Treatment Evaluation Unit (VTEU) was one of two sites in the nation where the COVID-19 vaccine was tested.
“These interim results are very encouraging,” says Evan Anderson, MD, principal investigator for the trial at Emory. Anderson is associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta.
“While there is still a lot of work to do before we have a vaccine that is proven to be safe and effective against COVID-19, this study provides critical information about the safety of the vaccine. Importantly, the vaccine resulted in a robust immune response.”
The Emory-based Infectious Diseases Research Consortium named the trial lead as Lisa A. Jackson, MD, MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, where the first volunteer received the vaccine on March 16. The interim report published details the initial results of the first 45 volunteers ages 18 to 55 years old. Emory enrolled 17 of those volunteers at the Hope Clinic or the Emory Children’s Clinic.
The interim analysis includes results of tests measuring levels of vaccine-induced neutralizing activity through day 43 after the second injection. Two doses of vaccine prompted high levels of neutralizing antibody activity that were above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease.
No serious adverse events were reported. Fatigue, headache, chills, myalgia and pain at the injection site were reported by more than half of the volunteers, with systemic adverse events being more common following the second vaccination and in those who received the highest vaccine dose.
“We are proud to be participating in the search for a vaccine to protect against COVID-19 by enrolling participants in this critical study,” says Nadine Rouphael, contact principal investigator at the Emory VTEU. Rouphael is also interim director of the Hope Clinic at the Emory Vaccine Center and associate professor of medicine (infectious diseases) at Emory University School of Medicine.
“Rising COVID-19 infection rates throughout the country show that the need for a vaccine has only become more urgent.”
Anderson and Rouphael are coauthors of the study published in NEJM.
The Emory and Seattle VTEU’s are part of NIAID’s Infectious Diseases Clinical Research Consortium, which is supporting the trial. The consortium is led by co-principal investigators David S. Stephens of Emory University, and Kathleen Neuzil of the University of Maryland School of Medicine. Dr. Stephens is professor and chair of the Department of Medicine in Emory University School of Medicine and vice president for research of Emory’s Woodruff Health Sciences Center.
“As the largest clinical trials network in the Division of Microbiology and Infectious Diseases at NIH, we are working to accelerate research that will identify a vaccine to combat COVID-19,” says Stephens. “We are excited about the promise of these early results and ready for the challenging work that lies ahead.”
A phase 2 clinical trial of mRNA-1273, sponsored by Moderna, Inc., began enrollment in late May and plans are underway to launch a phase 3 efficacy trial in July 2020.
Additional information about the trial design is available at clinicaltrials.gov using the identifier NCT04283461. This trial was supported in part by the NIAID grants UM1AI148373 (Kaiser Washington), UM1AI148576 (Emory University) and UM1AI148684 (Infectious Diseases Clinical Research Consortium). Funding for the manufacture of mRNA-1273 Phase 1 material was provided by the Coalition for Epidemic Preparedness Innovation (CEPI).
Learn More About Emory University’s COVID-19 Research
About the Infectious Diseases Clinical Research Consortium
Consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Health Care, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.