The University of Cincinnati is one of approximately 90 sites across the U.S. selected for this phase 3 clinical trial, 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 respiratory illness caused by the novel coronavirus SARS-CoV-2. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the study.
“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,” said Carl Fichtenbaum, MD, professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine and a UC Health physician.
Fichtenbaum is co-investigator of the study and will serve as medical director.
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 for three months, and previous studies 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.
“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,” Fichtenbaum said. “The hope is that the ongoing production of these proteins will generate antibodies that will protect against infection.”
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.
“We are all trying to very rapidly find a way to help patients and to prevent not only severe disease, but asymptomatic infection also,” 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.
“This is how healthcare and science move forward: people saying, ‘Yes, I’m willing to be involved. I see this as a community need, and this is my contribution.’ None of these studies would work without individuals in the community being willing to help,” she said.
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.
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.
Participant recruitment and screening is now underway, and enrollment is expected to begin in July. The first vaccines are expected to be administered in July.
Fichtenbaum and Powers-Fletcher are co-investigators of the study and declare no conflicts of interest.
Anyone with questions regarding this clinical trial can call 513-245-3417 or email UCcovidresearch@uchealth.com.