Fewer than 10 vaccines have passed tests on animals and small numbers of people to enter the final stage of clinical trials. Phase 3, the last test before government regulators consider a vaccine for approval, involves conducting a trial with thousands of people in multiple locations.
More than 1,000 Ohioans will be part of such research.
Dr. Carl Fichtenbaum, professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine and a UC Health physician, said the goal of the study is to prove the vaccine is “safe and effective.”
He said more than 30,000 people are expected to participate in the trial across the U.S., and UC, one of the 90 sites, plans to enroll 500 patients.
One of those patients is Dr. Brett Kissela, professor in the Department of Neurology and Rehabilitation Medicine at the UC College of Medicine. He has had two appointments. He said each visit has lasted about two hours. He has been impressed by the “level of detail” to the testing and the follow-up questions.
“The process of science leads to the best answers,” he said. “That whole process has to keep going.”
When asked why he volunteered to participate in the study, Kissela said he “wanted to make a contribution” to finding a cure for COVID-19.
“We need to get back to a normal life again and take control of this virus,” he said. “The risk is worth it to me.”
Fichtenbaum said UC will administer the vaccine candidate 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.
Under Operation Warp Speed, the U.S. government has bankrolled three vaccine candidates for phase 3 trials, including the vaccines being tested by UC and Ohio State Wexner Medical Center.
Dr. Zach Jenkins, associate professor of pharmacy practice at Cedarville University, said several factors are making this unprecedented rate of advancement possible: better technology, government support, political pressure and an urgent need to get back to normal.
Patients who participate in the 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, he said.
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, according to Fichtenbaum.
The trial should be complete by the end of September and researchers will know “how safe” the vaccine is by the end of October, he said. He’s “very thankful” for the volunteers in the clinical trial.
“There are lots of people who want to make this a better place,” he said. “They’re being selfless to make a better world for the rest of us and all our children.”
Staff writer Jordan Laird contributed to this report.
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