LOVELAND — UCHealth researchers in northern Colorado are now recruiting participants for a study that will test a COVID-19 vaccine candidate.
The study, which is the second 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 [thelancet.com] 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.
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 study 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.
UCHealth researchers held off on launching the northern Colorado 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 [astrazeneca.com] 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.
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 [uchealth.org] 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.
“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 battlin
g 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.”
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.
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