vaccine

A new COVID-19 vaccine clinical trial is starting in Colorado.

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

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.

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 Gregory M. Glenn, MD, president of R&D at Novavax. “We are grateful to the thousands of volunteers who are stepping forward to participate in this vital research.”

Dr. Thomas Campbell, UCHealth chief clinical research officer and an infectious disease physician at the CU School of Medicine, said 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.”

UCHealth and CU School of Medicine researchers will recruit study participants for the clinical trial, and they’ll 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.

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 interested in participating can also send an email to suzanne.fiorillo@cuanschutz.edu.