Phase 3 Clinical Trial Will Evaluate Efficacy of Moderna Vaccine Candidate
NEWS RELEASE: Amanda Nageleisen, Director of Media Relations
CINCINNATI, OH (August 25, 2020) – Earlier Tuesday, clinicians at UC Health and the University of Cincinnati College of Medicine administered the first dose in Cincinnati in a groundbreaking clinical trial that will evaluate the effectiveness of a vaccine for COVID-19, the respiratory illness caused by the novel coronavirus SARS-CoV-2.
The first patient to receive a dose in the study was Jarelle Marshall, 37, an IT professional who lives in Cincinnati.
“We’re all in this together. We all want to get things back open and get back to as normal as possible,” said Marshall, the father of a fourteen-year old son. “I try to always teach my son to walk the walk. You can say all these things and tell everybody something but to actually walk the walk and do what you say you’re going to do, and if you’re going to try to help people, you just do it.”
The first dose was administered via syringe by licensed pharmacists, and study participants will receive a second dose in approximately one month.
Patients who participate in the blinded, randomized, placebo-controlled study will receive either the vaccine, or a placebo, in two injections. The vaccine is incorporated into the patient’s cells, which should begin producing a viral antigen to which the immune system can respond. Patients will keep a daily electronic diary of their symptoms, and also participate in telehealth and clinic visits with UC Health clinicians over a two-year period
“Providing our community an opportunity to become part of the solution to ending the COVID-19 pandemic is very important. The COVE Trial places Cincinnati squarely on the cutting edge of new scientific discoveries and allows our citizens to take action and help us find a preventive vaccine for COVID-19,” said Carl Fichtenbaum, MD, co-investigator and medical director of the study.
Fichtenbaum is a professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine and a UC Health physician.
UC is one of approximately 90 sites across the U.S. selected for the study, which will administer the vaccine candidate mRNA-1273 to volunteer participants and monitor its efficacy in eliciting an immune response that provides protection from COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the study.
The mRNA-1273 vaccine was developed by NIAID scientists and collaborators at Moderna, a biotechnology company based in Cambridge, Massachusetts. The vaccine has been in development since March, and previous phases of the study have shown that mRNA-1273 elicits an immune response similar to individuals who have recovered from COVID-19.
The Phase 3 clinical trial will provide more data about the vaccine’s efficacy. More than 30,000 people are expected to participate across the U.S., and UC plans to enroll 500 patients locally.
“Study participants will receive either a placebo or vaccine, then be monitored over time to see if they get sick with COVID-19 from a natural exposure. Through this scientific process, we will find out if the vaccine is effective at preventing SARS-CoV-2 infections and severe COVID-19 and, if so, how long that protection lasts,” said Maggie Powers-Fletcher, PhD, D(ABMM), assistant professor in the Division of Infectious Diseases at the UC College of Medicine and co-investigator on the study.
Unlike conventional vaccines, which often use a small amount of live virus or antigen to stimulate 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 this COVID-19 mRNA vaccine, the protein that is made is similar to one that is normally made by the virus during an infection. This allows the body’s immune system to be stimulated and respond in a way that is protective, without being exposed to the actual virus.
mRNA-1273 is one of more than two dozen COVID-19 vaccines in development across the U.S., as the international scientific community works to learn more about the novel coronavirus and develop ways to prevent and treat it.
The vaccine study is among dozens of COVID-19 clinical trials currently underway at UC and UC Health, including studies to evaluate the efficacy of convalescent plasma as a treatment, and the creation of a biorepository to help scientists better study COVID-19 and the novel coronavirus.
UC Health and UC have a long history of leading the way in scientific discovery and innovation.
During the 1950’s, Albert Sabin, MD, head of pediatric research at Cincinnati Children’s Hospital Medical Center and UC, developed the oral polio vaccine, which played a key role in nearly eradicating polio. Many other recognizable and widely-used treatments and protocols, including the development of Benadryl and the FAST (F-face, A-arm, S-speech, T-time) method for identifying signs of a stroke, were developed in Cincinnati.
Those eligible for the COVID-19 vaccine trial include adults at least 18 years of age with no known history of SARS-CoV-2 infection, but are at risk of becoming infected. In addition to healthy individuals, patients at risk for severe COVID-19 disease, such as those with diabetes, heart or lung disease, or other chronic medical conditions, will also be included in the study.
For information or to enroll in the study, call 513-245-3417, email UCcovidresearch@uchealth.com, or visit https://survey.uchealth.com/redcap/surveys/?s=9LR7JXHXJH.