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Researchers at the University of Colorado School of Medicine and UCHealth on the CU Anschutz Medical Campus will recruit qualified patients throughout Colorado for a study testing a promising COVID-19 vaccine candidate.
The recruitment period will run about two months at UCHealth University of Colorado Hospital and is the only hospital in Colorado for this study.
“Our site here at University of Colorado Hospital is part of a nationwide network called the COVID Prevention Network, which is set up so that it has a cohort of sites that are available to sequentially enroll into multiple vaccine studies,” said Dr. Thomas Campbell, an infectious disease physician at the CU School of Medicine and University of Colorado Hospital. “If it works, the Moderna vaccine could be a real game-changer for the pandemic.”
UCHealth and the CU School of Medicine will recruit 1,000 patients for the trial, and participants will be monitored for at least a year to determine the vaccine’s safety and whether they contract COVID-19. Patients from throughout Colorado will be invited to participate, though they will have to travel to University of Colorado Hospital for their appointments.
“UCHealth is dedicated to groundbreaking research to discover treatments and vaccines to fight diseases like COVID-19. This is one of more than 15 COVID-19 clinical trials in which UCHealth locations are participating, and additional research studies are planned with our CU partners to continue protecting patients and improving outcomes,” said Dr. Margaret E. Reidy, UCHealth chief medical officer.
Unlike traditional vaccines which expose someone to a small amount of virus, the Moderna mRNA-1273 vaccine focuses on the genetic code of the coronavirus and its spike protein, Campbell said. The coronavirus gets its name from the crown of spikes seen through an electron microscope. The spike proteins are crucial for replication of the virus, as they attach to cells in the human body and cause infection. The vaccine’s purpose would be to induce an antibody response against the protein that would prevent the virus from infecting cells, Campbell said. This method may stimulate the body’s immune system without exposing someone to the actual virus.
“The coronavirus pandemic has had a profound impact on global health. But it has also sparked a global collaboration of scientists and researchers unlike anything we’ve seen before,” said Donald M. Elliman Jr., chancellor of the CU Anschutz Medical Campus. “As a top academic medical campus, we are uniquely positioned to take part in these potentially groundbreaking clinical trials as we all work to bring an end to COVID-19.”
The emphasis of this vaccine trial is on demonstrating its efficacy in people who are most at-risk for contracting and becoming ill from COVID-19. This includes those who could be vulnerable because of their occupation, such as employees of crowded facilities, health care workers who treat patients with COVID-19, first responders, and those who work in food processing facilities. UCHealth will also recruit individuals in higher-risk groups including Black, Indigenous and Hispanic patients as well as those with certain health conditions, including those over 65 years old and people suffering from diabetes, obesity, heart disease, lung disease, or chronic kidney disease. Participants in the randomized, observer-blind trial will either receive the vaccine or a placebo.
Clinical trials typically take several years and proceed in sequential order, but the mRNA-1273 trial is proceeding far more rapidly as researchers around the world race to develop a successful vaccine. However, physicians warn that setbacks are possible.
“I’m elated by the pace of progress. It’s really unheard of for any viral infection to have a vaccine progress at this rate,” Campbell said. “It’s a great testament to what can be done when people put their minds to it and work together. I’m certainly hopeful that we’ll have success, but the sad reality is that most vaccine candidates don’t turn out to be successful so we have to be prepared for failures as well.”
The collaboration among the CU Anschutz partners is responsible for this opportunity.
“This trial is possible due to the productive collaboration between the University of Colorado School of Medicine and UCHealth. We are honored to be have this opportunity to advance the science and work towards a solution to the COVID-19 pandemic,” said Dr. Jean Kutner, chief medical officer for UCHealth University of Colorado Hospital.
Potential participants will be contacted through UCHealth’s My Health Connection patient portal and invited to participate if they meet the criteria for the trial.