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. Researchers are beginning the process of pre-screening volunteers and a brief survey is being sent out to the roughly 2,100 people who have signed up to take part in the trial, which is scheduled to start Aug. 24.
Fichtenbaum, in his first newspaper interview, told the Journal-News that those who volunteer for the study will be “heroes” because of the possible breakthroughs in the fight against the coronavirus.
“We will be forever grateful,” he said of the volunteers. “What they do, through their sacrifice, volunteerism, and participation, truly amazes me.”
Fichtenbaum, co-investigator of the study and medical director, said UC 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.
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.
Those eligible for the COVID-19 vaccine trial include adults at least 18 years of age with no known history of the infection but who 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.
The mRNA-1273 vaccine was developed by NIAID scientists and collaborators at Moderna, a biotechnology company based in Cambridge, Mass. 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 hope is that the ongoing production of these proteins will generate antibodies that will protect against infection,” he said.
This vaccine 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.
Typically, vaccines may take years to be developed and approved.
But Fichtenbaum said scientists are frantically trying to create a vaccine because of the seriousness of the coronavirus. It’s estimated that 760,000 people worldwide and 169,000 in the U.S. have died from COVID-19.
“This is a world emergency and we have to work much quicker,” he said. “The timelines that are set are emergency timelines. We are really trying to help the world be a better place. Science is a great way to solve problems. It’s time to roll up our sleeves and find answers.”
About the Author
