The University of Cincinnati (UC) has been selected by the National Institute of Allergy and Infectious Diseases (NIAID) as a clinical investigational site for the pivotal Phase III clinical trial evaluating the effectiveness of Moderna’s mRNA-1273 COVID-19 vaccine. As one of 90 sites across the United States selected for the critically important study, UC gears up to do its part in combating COVID-19.
Serving as study co-investigator as well as medical director, Carl Fichtenbaum, MD with the UC College of Medicine Division of Infectious Diseases, reports, “UC was chosen because we have a proven track record of high-quality research and are the number one site in the NIAID-funded, AIDS Clinical Trials Group in the U.S. We are proud to bring leading-edge research to Cincinnati so that we can help our community battle the COVID-19 pandemic and be part of the solution.”
A History of Important Research Results
UC Health and UC-based scientific discovery goes back quite a long time. For example, in the 1950s, a pediatric researchers at Cincinnati Children’s Hospital Medical Center and UC, Albert Sabin, developed the oral polio vaccine, playing a key role in nearly eradicating polio. And UC has been involved with many other important research investigations such as the development of Benadryl and the FAST (F-face, A-arm, S-speech, T-time) method for identifying signs of a stroke.
The Vaccine Candidate
Moderna’s mRNA-1273 is one of the lead COVID-19 candidates at the present time. Dr. Fichtenbaum reports, “The Moderna vaccine is a leading-edge technology using a genetic code to produce proteins like those seen with infection with COVID-19, allowing the body to respond.” He continued, “The hope is that the ongoing production of these proteins will generate antibodies that will protect against infection.”
mRNA-1273 is based on an altogether different approach to vaccines known as a messenger RNA based vaccine. Unlike conventional vaccine, which often use nominal amounts of live virus or antigen to trigger an immune response, messenger RNA (mRNA) vaccines communicate with the body’s cells in a way that directs the cell to produce proteins. In the case of a COVID-19 mRNA vaccine, the protein that is made is comparable to one that is normally produced by the virus during an infection. Hence, the body’s immune system is stimulated and can respond in such a way that is protective, absent any exposure to the actual virus.
The Phase III Clinical Trial
This major clinical trial will provide more data about the vaccine’s efficacy. With over 30,000 participants targeted for enrollment across America, UC plans on enrolling 500 local participants. This number of participants would be higher than the average, evidencing the higher expectations for UC.
Carl Fichtenbaum, MD, UC College of Medicine Division of Infectious Diseases, Co-investigator
Maggie Powers-Fletcher, PhD, (ABMM), assistant professor, Division of Infectious Diseases, UC College of Medicine, Co-investigator
Call to Action: UC has commenced participant recruitment and screening. Actual enrollment is expected to start in July. The first vaccines are planned to start in July as well. For individuals residing in the Cincinnati area, consider participation if you fit the eligibility criteria. If you have questions, contact the study team at 513-245-3417 or email at [email protected].