This Phase Three vaccine trial aims to enroll 1,500 participants in northern Colorado.
DENVER — UCHealth announced Thursday that researchers in northern Colorado are 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, aims to enroll 1,500 participants in northern Colorado. Nationally, more than 30,000 volunteers will be participating in the trial.
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.
Trial participants will be ages 18 and older who are at higher risk for exposure due to their work environments or habits, according to UCHealth. This higher-risk group will include occupations such as health care workers, teachers, first responders or grocery store workers. 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.”
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UCHealth said the vaccine candidate 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.
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, UCHealth said in a news release.
“Theoretically, it sounds good,” said Luckasen. “The question is how much resistance does it cause, and is that enough to stop the virus in the future?”
“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.”
Some of the 1,500 Colorado participants for this Phase Three 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, according to 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.”
Those who are interested in participating should go to bit.ly/NoCoVaccineStudy for more information and to see if they qualify.
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