UCHealth is recruiting 1,500 participants from Northern Colorado to test a potential COVID-19 vaccine.
The study, the second vaccine trial to start at UCHealth, will include participants age 18 and older who are at higher risk for exposure due to their work, including health care workers, teachers, first responders and grocery workers.
Participants may also 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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Two out of every three participants will get the vaccine developed by Oxford University and AstraZeneca, while the other will get a placebo, he said.
Carrie Hintzman, a secretary in the athletics department at Fossil Ridge High School, enrolled in the trial Sept. 4 during what UCHealth calls a “soft launch.” She was the first and only participant to walk through the process that day.
Hintzman received her first booster shot on Thursday. Thus far, she has had no side effects but doesn’t know if she is receiving the vaccine or a placebo. She didn’t come down with the virus after coming in contact with her son, who tested positive a week after their visit. “Hopefully, I got the real one,” she said.
She hasn’t been able to see her 84-year-old mother or sister who lives in an assisted living center since the pandemic began, she said.
“It’s very difficult staying at home all the time. I just want things to go back to normal. I want kids to be able to come back to school. It’s not great for them. It’s not great for people to be in their houses all the time,” she said.
“I don’t want people to go on dying.”
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UCHealth began recruiting participants, including Hintzman, last month but held off on a full launch after AstraZeneca paused its global trial when a participant in the United Kingdom developed an unexplained illness.
Last week, the U.S. Food and Drug Administration confirmed it was safe to resume the clinical trial in the United States.
According to UCHealth, results from initial phases of the vaccine published in the medical journal Lancet indicate the vaccine generates an antibody response. According to the report, most participants had neutralizing antibodies after one dose; all 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 body looks at the protein and thinks it’s coronavirus,” Luckasen said. “The body builds up an immunity so when it gets attacked by the virus, the body will be set up to have an immune response to stop it from infecting you. Without that protein, it can’t get into your cells and replicate or cause 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?”
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UCHealth said it will identify some potential participants through its patient records and invite them to take part in the trial.
Others who are interested can answer prescreening questions online.
Enrollment will occur over eight weeks and take place at the McKee Pavilion at The Ranch Events Complex in Loveland.
How to help with the COVID-19 vaccine trial
To see if you qualify for the study, visit bit.ly/NoCoVaccineStudy for more information.
Pat Ferrier is a senior reporter covering business, health care and growth issues in Northern Colorado. Contact her at email@example.com. Please support her work and that of other Coloradoan journalists by purchasing a subscription today.