UCHealth launches second COVID-19 vaccine trial

Phase 3 clinical trial of COVID-19 vaccine aims to enroll 1,500 participants in northern Colorado.
October 29th, 2020
A sign points to where the vaccine trial is being conducted in northern Colorado..
UCHealth researchers in northern Colorado are recruiting participants for a COVID-19 trial that will test a new vaccine candidate developed by Oxford University and pharmaceutical company AstraZeneca. Photo courtesy of UCHealth.

UCHealth researchers in northern Colorado are now recruiting participants for a study that will test a COVID-19 vaccine candidate.

A nurse administers a shot to a woman during a COVID-19 vaccine trial in northern Colorado..
UCHealth registered nurse and research coordinator Stacie Kenny administers a shot to the first participant of UCHealth’s COVID-19 vaccine trial being conducted in northern Colorado. Participants in the study receive either a placebo vaccine or a vaccine developed by Oxford University and pharmaceutical company AstraZeneca. Photo courtesy of UCHealth.

The study, which is the second COVID-19 vaccine trial to launch at UCHealth, will include approximately 1,500 participants ages 18 and older who are at higher risk for exposure due to their work environments or habits. This includes occupations such as health care worker, teacher, first responder or grocery store worker. Qualified participants also may have a stable health condition that puts them at risk of contracting COVID-19 or developing serious illness from the disease.

“This will give us a large group of people who will receive the vaccine – or a placebo vaccine – to see if it’s truly effective over a few weeks, a few months and up to two years,” said Dr. Gary Luckasen, the principal investigator of the trial and medical director of UCHealth’s clinical research program in northern Colorado. “The size of the group is of major importance because we can get a lot of information about the virus, the vaccine and how they interact.”

The vaccine was developed by Oxford University and pharmaceutical company AstraZeneca. Results from initial phases of the study on this particular vaccine were recently released and indicate the vaccine generates an antibody response. According to the report, most participants had neutralizing antibodies after one dose, and all participants had the antibodies after two doses.

Dr. Gary Luckasen stands in front of UCHealth Medical Center of the Rockies in Loveland, Colorado.
Dr. Gary Luckasen, MD, is a cardiologist and medical director of UCHealth’s clinical research program in northern Colorado. He is the principal investigator of UCHealth’s Phase 3 study of a new COVID-19 vaccine candidate developed by Oxford University and pharmaceutical company AstraZeneca. Photo by Kelly Tracer, UCHealth.

Unlike traditional vaccines, which expose someone to a small amount of virus, this vaccine is an inactive cold virus – adenovirus – combined with a protein that is seen on the outside of the SARS-CoV-2 coronavirus. The protein is an essential element that enables the coronavirus to infect a person. If the vaccine works as intended, the body will identify the protein as foreign and develop an immunity to it. Then, when the person is exposed to the new coronavirus in the community, the person will already have the ability to attack the virus and prevent infection.

“Theoretically, it sounds good,” Luckasen said. “The question is how much resistance does it cause, and is that enough to stop the virus in the future?”

Some of the 1,500 Colorado participants for this Phase 3 study will be identified through UCHealth patient records and invited to participate. Others who are interested in participating can answer pre-screening questions online to see if they qualify. Enrollment for the COVID-19 vaccine trial in northern Colorado will occur over an eight-week period with all of the enrollment activities taking place by appointment only at the official study site, which will be in the McKee Pavilion at The Ranch in Loveland.

A nurse prepares a shot that may contain a vaccine for COVID-19 during a trial in northern Colorado..
UCHealth registered nurse and research coordinator Stacie Kenny prepares a shot to be administered to the first participant of UCHealth’s COVID-19 vaccine trial being conducted in northern Colorado. Participants in the study will receive either a placebo vaccine or a vaccine developed by Oxford University and pharmaceutical company AstraZeneca. Photo courtesy of UCHealth.

UCHealth researchers held off on launching the northern Colorado COVID-19 vaccine study last month when the sponsor voluntarily and temporarily paused the trial worldwide to allow for a thorough evaluation and review of a single event of an unexplained illness that occurred in the United Kingdom. Last week, the U.S. Food and Drug Administration confirmed it was safe to resume the clinical trial in the United States. According to Luckasen, this pause was a good example of the lengths that physicians, researchers and companies will go during a clinical trial to ensure patients and study participants are safe.

Nationally, more than 30,000 volunteers will be participating in the trial. Once enrolled, study participants will be randomized to receive either the vaccine or a placebo. They will be monitored for up to two years to determine the vaccine’s safety and whether they contract COVID-19. There is no compensation for participants of this study.

A number of potential participants will be contacted through UCHealth’s My Health Connection patient portal and invited to enroll in UCHealth’s vaccine trial in northern Colorado. Others who are interested in participating should go here for more information and to see if they qualify.

Dr. Thomas Campbell, chief clinical research officer of UCHealth, said this is one of about 40 COVID-19 clinical trials in which UCHealth locations are participating. In July, UCHealth announced it was partnering with CU School of Medicine to recruit participants for another vaccine trial at University of Colorado Hospital on the Anschutz Medical Campus. That trial, which wrapped up enrollment last week, is testing a COVID-19 vaccine candidate manufactured by Moderna.

Both of the COVID-19 vaccine trials at UCHealth focus on vaccines that are supported by Operation Warp Speed, the U.S. government program that aims to accelerate the development, production and distribution of a safe and effective vaccine for COVID-19 and other therapeutics.

A health care provider is talking to a woman who is sitting in a laboratory blood draw chair to screen her for a COVID-19 vaccine trial in northern Colorado..
UCHealth community health specialist Joanna Friedt, right, prepares to conduct a blood draw from Carrie Hintzman of Fort Collins as part of the medical screenings process for a COVID-19 vaccine trial in northern Colorado at a Loveland study site. Photo courtesy of UCHealth.

“All of the vaccines are a little different than each other, so the trials that are being conducted around the world right now are key to determining what approach is going to work best in the fight against COVID-19,” said Dr. Diana Breyer, chief quality officer for UCHealth’s northern Colorado facilities. “To be selected to conduct this type of groundbreaking research is a true testament to the expertise of our research programs and our experience collaborating as a system and with our partners to push the boundaries of innovation to improve care and outcomes.”

UCHealth’s robust clinical research program in northern Colorado has been on the forefront of numerous medical trials in recent years, from assessing the latest devices created to repair ailing hearts to developing more efficient and effective ways to treat trauma patients to collaborating globally on efforts to better target and attack cancer.

“We do major clinical trials that affect heart valves and patients who have experienced severe trauma or are battling cancer. It’s all very impressive and important research, especially to those people who are affected or may someday be affected,” Luckasen said. “This COVID vaccine study is a bit different. COVID-19 is affecting absolutely everyone right now, and everyone wants to get back to a more normal life. If we are able to develop a successful vaccine, the quicker we do it is going to be better for everyone.”

About the author

Kelly Tracer is a media relations specialist at UCHealth, based in northern Colorado. For nearly 20 years, she worked as a newspaper reporter, editor and designer before diving into the world of health care communications.

She believes there is an amazing story inside everyone and considers it an honor to get to meet and work with so many extraordinary people – patients, families, providers, volunteers and staff – every day. She is also fascinated by health care innovation and programs that empower and inspire people and families to live healthier lives.

A native of Nebraska, Kelly received a bachelor’s degree in journalism from the University of Nebraska – Lincoln. She and her husband have two children and enjoy paddle boarding all summer and skiing all winter.