At the onset of the COVID-19 pandemic, the national research apparatus rapidly responded, mobilizing a powerful clinical trial site network known as the Vaccine Treatment and Evaluation Unit (VTEU). This is part of the National Institute of Allergies and Infectious Diseases (NIAID) Infectious Diseases Clinical Research Consortium or IDCRC. The VTEU units, such as at Emory, have played a key role in NIAID’s efforts to develop new and improved vaccines and therapies targeting infectious diseases for nearly half a century. Emory University in Atlanta represents a key player in this network. The Emory VTEU, active since 2007, was activated in early March by NIAID to commence trials investigating vaccines and therapies targeting COVID-19. Now, coming back full circle, Emory University yet again represents a key trial site in the nationwide Phase 3 clinical trial investigating the COVID-19 vaccine known as mRNA-1273.
Just this week, Emory News Center reported that Hope Clinic of Emory Vaccine Center dosed the first volunteer in the pivotal vaccine trial. Emory is recruiting hundreds of volunteers 18 and older for enrollment at one of three clinics, including 1) Emory Children’s Clinic, 2) the Hope Clinic of Emory Vaccine, and 3) Grady Health’s Ponce de Leon Center.
Evan Anderson, an associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta, expressed the tone and mood at study onset: We’re excited to be part of this next critical study in seeking a vaccine to combat COVID-19.” Dr. Anderson continued, “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.”
Nadine Rouphael, MD, associate professor of medicine (infectious diseases) with Emory University School of Medicine, leads the overall study at the Hope Clinic where she serves as interim director. Dr. Rouphael has been a key player in the war against COVID-19. During the remdesivir trials, TrialSite reported she was one of the leads of the highly productive Emory site.
Colleen Kelley, MD, MPH, oversees the study at the Ponce de Leon Center. Dr. Kelley, a professor of medicine, specializes in infectious diseases at Emory University School of Medicine.
Emory: There from the Start
As mentioned ,Emory University is a key player in the NIAID VTEU and was one of three sites that led the Phase 1 clinical trial for mRNA-1273. Thanks to the tireless work of Emory and the other sites, the study produced early results indicating the experimental vaccine developed by Cambridge-based Moderna and NIAID, was overall safe and generated an immune response among participants.
The Phase 3 Study
With over 80 sites now involved, the sponsor Moderna, along with partner NIAID, plan to enroll 30,000 in this pivotal Phase 3 clinical trial NCT04470427, testing the advanced mRNA-based vaccine candidate targeting COVID-19. Those individuals residing in the Atlanta area that meet the inclusion criteria could consider participating. COVID-19 has turned the world upside down, millions are infected, and over 165,000 have died in the United State alone in less than half a year. A safe and effective vaccine is desperately needed.
Although the Russian government has authorized the “Gamaleya” vaccine, the authorities there actually skipped the pivotal Phase 3 stage of research. The data generated from this pivotal stage can literally lead to an interpretation of a commercial ready safe and effective vaccine for COVID-19.
That’s why it’s important that full participation represents Phase 3 trials in the United States. At Emory, which has been a key partner to the U.S. government, industry, and the community since the start, the teams are again mobilized and ready to initiate its research apparatus to randomly assign eligible participants to either the tested vaccine or placebo. Individual participants will receive two injections spaced 28 days apart.
Check out Emory’s Frequently Asked Questions. For those interested in participation, consider a pathway to volunteering, whether it be the COVID-19 Prevention Network (a reorganized and streamlined group of NIAID-backed infectious disease trial sites), Emory Vaccine Center Hope Clinic, Emory Children’s Center, and Ponce Center.
VTEU National Administration
Emory is part of the broader NIAID VTEU that is led by co-principal administrators David S. Stephens of Emory University School of Medicine and Kathleen Neuzil, a professor with University of Maryland School of Medicine.