Emory’s Vaccine and Treatment Evaluation Unit (VTEU) is participating in a clinical trial testing a vaccine for the prevention of COVID-19, the first such vaccine to be tested in the United States.
The goals of the Phase I study, which began on March 16 at the VTEU at the Kaiser Permanente Washington Health Research Institute in Seattle, are to test whether the investigational vaccine is safe, and how much it stimulates the immune system. If the vaccine is found to be safe, future studies will examine whether it can prevent infection.
The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Emory VTEU is part of NIAID’s Infectious Diseases Clinical Research Consortium supporting this trial. Emory has been a VTEU site since 2007.
The principal investigator for this study at Emory is Evan Anderson, MD, and Nadine Rouphael, MD is serving as the Emory VTEU contact principal investigator. Anderson is associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta. Rouphael is interim director of the Hope Clinic of the Emory Vaccine Center and associate professor of medicine (infectious diseases) at Emory University School of Medicine.
“The COVID-19 pandemic has caused substantial morbidity and mortality in the US and worldwide along with causing massive social disruption,” Anderson says. “The Emory VTEU is proud to contribute to enrolling people into this critical Phase I study evaluating the first vaccine candidate against COVID-19.”
“A vaccine against COVID-19 is urgently needed because of widespread infection and lack of preexisting immunity,” Rouphael says. “We are looking forward to being part of a nationwide effort to respond to this crisis.”
The vaccine is called mRNA-1273 and was developed by NIAID and Moderna, Inc. The vaccine is based on messenger RNA, which tells some cells in the body to make a viral protein. The RNA-based approach allows for faster vaccine development than older methods. The vaccine does not contain coronavirus itself and cannot cause infection.
The trial aims to enroll 45 participants total across the two sites. Participants must be adults in the Atlanta area age 18 to 55. To be eligible, they can’t have chronic diseases or health conditions that affect the immune system, and they can’t be taking immunosuppressive medications. Other criteria and additional information about the vaccine study are available at ClinicalTrials.gov.
The Emory VTEU is supported by the National Institute of Allergy and Infectious Diseases (UM1AI148576).