Investigational clinical trial for new COVID-19 vaccine opens in Colorado

Jan. 12, 2021

Researchers at the University of Colorado School of Medicine and UCHealth on the Anschutz Medical Campus are now recruiting potential study participants for another COVID-19 investigational vaccine clinical trial. This is the third COVID-19 vaccine trial underway at UCHealth locations.

The investigational vaccine, NVX-CoV2373, which contains a protein antigen and the company’s Matrix-M™ adjuvant, is being evaluated in a phase 3 clinical trial sponsored by Novavax and supported by the National Institutes of Health.

“This pivotal phase 3 clinical trial in the U.S. and Mexico is critical to building on the encouraging safety and immunogenicity data we’ve generated to-date and ultimately demonstrating how well NVX-CoV2373 works to prevent COVID-19,” said Dr. Gregory M. Glenn,  President of R&D, Novavax. “We are grateful to the thousands of volunteers who are stepping forward to participate in this vital research.”

The recruitment period will run about two months at UCHealth University of Colorado Hospital which is the only hospital in Colorado participating in this clinical trial.

“University of Colorado Hospital is part of the nationwide network called the COVID-19 Prevention Network, which has sites that are available to enroll into multiple sequential vaccine studies,” said Dr. Thomas Campbell, UCHealth Chief Clinical Research Officer and an infectious disease physician at the CU School of Medicine.

Dr. Thomas Campbell talks about COVID-19 clinical trials in Colorado.
Dr. Thomas Campbell

UCHealth and CU School of Medicine researchers will recruit study participants or the clinical trial, and participants will be monitored for two years to determine the vaccine’s safety and whether they contract COVID-19. Study participants from throughout Colorado will be invited to participate, though they will have to travel to the Anschutz Medical Campus for their appointments.

Two-thirds of the study participants will receive one dose of NVX-CoV2373 21 days apart; one third will receive a placebo.

UCHealth is also participating in the AstraZeneca COVID-19 vaccine trial in northern Colorado, and the Moderna COVID-19 vaccine trial wrapped up at University of Colorado Hospital at the end of October after enrolling more than 180 study participants.

“Identifying, inviting and enrolling study participants in trials like this takes a significant amount of work, and the Clinical and Translational Research Center (CTRC) research nurses and scheduling staff should be commended for their work along with UCHealth’s IT and My Health Connection teams who have used our electronic medical record in innovative ways to invite study participants to participate in the trial,” said Dr. Jean Kutner, chief medical officer of University of Colorado Hospital.

“CU’s world-class researchers have long excelled at bringing the latest clinical trials to our campus and we’ll continue to do that with COVID-19 vaccines and treatments,” said Donald M. Elliman Jr., chancellor of the CU Anschutz Medical Campus. “Today’s announcement is further evidence of how we continue to make strides with important research that showcases our strength as a leading academic medical campus.”

The emphasis of the Novavax phase 3 trial is on demonstrating safety and effectiveness of the vaccine in people who are most at-risk for contracting and becoming ill from COVID-19. UCHealth will also recruit individuals in higher-risk groups including Black, Hispanic, American Indian and Alaska Native study participants 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.

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.  Anyone who is interested in participating can also send an email to [email protected]