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ATLANTA, GA. EMORY: Phase 3 of COVID-19 vaccine trial launches at Emory

Emory University News Center | Woodruff Health Sciences Center

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Aug. 11, 2020

Emory administered its first dose of the vaccine at the Hope Clinic of Emory Vaccine Center this week. Hundreds of adult volunteers 18 and older will ultimately be enrolled at three clinics: Emory Children’s Clinic, the Hope Clinic of Emory Vaccine Center, and Grady Health’s Ponce de Leon Center.

“We’re excited to be part of this next critical study in seeking a vaccine to combat COVID-19,” says Evan Anderson, principal investigator for the trial at Emory, as well as associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta.

“As the death toll from this pandemic continues to rise, it becomes even more urgent that we find a safe and effective vaccine to prevent COVID-19. Having this trial take place at Emory gives Atlanta-area residents the opportunity to participate in a study that, if successful, has the potential to help stem the tide of this disease.”

 

 

The experimental vaccine, mRNA-1273, was co-developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and biotech company Moderna, Inc. of Cambridge, Massachusetts.

Emory University was one of three sites that took part in a Phase 1 study of the same vaccine. Early results from that study found the vaccine was generally well tolerated and generated an immune response among participants.

The new larger study (expected to enroll about 30,000 people at more than 80 sites) is designed to test whether the investigational vaccine can effectively prevent COVID-19 infection or prevent severe symptoms and death associated with infection. Participants will be randomly assigned to receive either the tested vaccine or placebo, given in two injections spaced 28 days apart.

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People taking part in the study will be monitored for safety through regular clinic visits. Additionally, they will be tested over two years to see who becomes infected in the course of their daily lives. For more information about participating in the study, please see this list of Frequently Asked Questions.

Nadine Rouphael, MD, associate professor of medicine (infectious diseases) at Emory University School of Medicine, is leading the study at the Hope Clinic, where she is interim director.

Colleen Kelley, MD, MPH, associate professor of medicine (infectious diseases) at Emory University School of Medicine, is overseeing the study at the Ponce de Leon Center.

Those interested in participating in the trial at Emory may volunteer through the following:

The study is supported by Emory’s Vaccine and Treatment Evaluation Unit (VTEU), which is part of NIAID’s Infectious Diseases Clinical Research Consortium (IDCRC) and the COVID-19 Prevention Network (CoVPN) supporting this trial. Emory has been a VTEU site since 2007. The consortium is co-led by co-principal investigators David S. Stephens of Emory University School of Medicine, and Kathleen Neuzil of the University of Maryland School of Medicine. Stephens is professor and chair of Emory’s Department of Medicine and vice president for research of the Woodruff Health Sciences Center.

Additional information about the trial design is available at clinicaltrials.gov using the identifier NCT04470427. This trial at Emory was supported in part by the NIAID grant UM1AI148576.

RELATED STORY

Phase 3 of COVID-19 vaccine trial launches at Emory

Woodruff Health Sciences Center | July 14, 2020

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.

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PHOTO: 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. Credit: Emory University’s Vaccine and Treatment Evaluation Unit (VTEU)/Woodruff Health Sciences Center

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.

SOURCE: https://news.emory.edu/stories/2020/07/coronavirus_vaccine_tested_safe_generates_early_response/index.html

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