Uchealth launches vaccine trial
A clinical trial for a coronavirus vaccine launched in Northern Colorado on Thursday with activities based at The Ranch in Loveland. Uchealth researchers are recruiting people willing to test the potential vaccine.
About 1,500 adults are needed for the clinical trial, and researchers are looking for people who are at higher risk for exposure because of how much they come into contact with others, such as teachers, grocer y workers, first responders, dentists and other health care workers.
“This is an excellent vaccine, and I think the science behind it seems to be ver y sound,” Dr.
Gar y Luckasen, who is based at Medical Center of the Rockies in Loveland and is running the clinical trial in Northern Colorado, said in an inter view via Zoom. “I hope it will be effective. It seems to be effective in initial trials.”
Carrie Hintzman, a Fort Collins resident and athletic secretar y at Fossil Ridge High School, is the first participant, already receiving her first vaccine shot. She spoke, in a recorded inter view, of the many teachers, students and coaches she interacts with on a daily basis.
“I came here today because I just want things to go back to normal,” Hintzman said in the inter view provided by
Uchealth. She said she has not been able to see her 84-year-old mother or her sister, who is in assisted living, since the pandemic started because of the high risk of infecting them.
She said it’s been very difficult to stay home and not see family members. Participating in the clinical trial, at least through the initial screening, testing and vaccine, has been easy — something she can do, she said.
“I don’t want people dying,” said Hintzman.
The clinical trial is one of several under way by research groups across the countr y and is the second vaccine trial to launch with Uchealth, which is running this clinical trial for the manufacturer, Astrazeneca. The study will include about 1,500 Colorado participants, some of whom will be invited based on their Uchealth records, and others who simply volunteer and are screened to see if they are good candidates.
Nationally, 30,000 people will participate, and those who sign up will be monitored for two years to gauge the safety of the vaccine and whether they contract the virus.
Two-thirds of the participants will receive the vaccine, and one-third will receive a placebo. Researchers then will study whether the vaccine is effective over a few weeks, a few months and up to two years, explained Luckasen, medical director of Uchealth’s clinical research program in Northern Colorado and the principal investigator of the trial. He said participants should expect three to four visits with researchers over the two-year period.
Luckasen said the size of the group is important to obtaining good information about the virus, the vaccine and how they interact.
This particular vaccine was developed by Oxford University and Astrazeneca, a pharmaceutical company. It is made with an inactive cold virus combined with a protein that is seen on the outside of COVID-19, and not with any exposure to the novel coronavirus itself.
The protein, Luckasen said, is what allows the virus to get into a person’s cells and replicate. The idea is that the body will think it is being attacked by the coronavirus, though it is not, and build up immunity.
“It’s just that simple,” Luckasen said in a recorded inter view provided by Uchealth. “You build up immunity by fooling your immune system, and you take care of the virus next time it comes around, so we are stopping the coronavirus, and we all get back to doing things we like to do.
“That’s such a huge need right now. Ever ybody is hoping that it works the way we all think it will,” he said.
The results of initial studies, which were released recently, indicate that the vaccine generates an antibody response and that most participants had neutralizing antibodies after one or two doses, according to information from Uchealth.
“Theoretically, it sounds good,” Luckasen said, according to a press release. “The question is how much resistance does it cause, and is that enough to stop the virus in the future?”
The Northern Colorado study was initially to launch last month, and Hintzman, the first participant, received her vaccine shot on Sept. 4. But before the trial could be expanded, it was delayed after the sponsor paused it worldwide due to a single unexplained illness that occurred in the United Kingdom.
After a “thorough evaluation and review,” the U.S. Food and Drug Administration last week said it was safe to resume the clinical trials, so Uchealth has now launched the study in Northern Colorado and opened enrollment on Thursday.
Luckasen said the worldwide delay illustrates the lengths researchers will go to for safety, according to the press release.
“In my feeling it’s exceedingly safe, and I think the six-week pause was something that contributed to us knowing it’s safe,” Luckasen said in an inter view over Zoom.
Now that the study is under way, people interested in participating can visit a website (bit.ly/nocovaccinestudy) to answer prescreening questions to see if they qualify. Enrollment for the study will occur over the next eight weeks, by appointment only, at a location at The Ranch complex in Loveland. Participants receive the vaccine but no other compensation.
Luckasen said he hopes to have all 1,500 participants enrolled by Thanksgiving, and he does not anticipate having trouble finding that number of people willing to sign up.
“I think that we’re going to see a significant amount of community interest because people want a vaccine,” he said, mentioning recent spikes in coronavirus cases, including in Northern Colorado, and predictions of surges in cases this fall and winter.
“The benefit comes not for the individual, but for the community,” Luckasen said. “If we can get a lot of people vaccinated, I think that bodes well for the community.”
This is one of about 40 COVID-19 trials in which Uchealth locations are participating, including one for a vaccine manufactured by Moderna that is being conducted in partnership with the CU School of Medicine. Enrollment for that trial wrapped up last week.
Both clinical trials, according to information from Uchealth, focus on vaccines supported by a U.S. government program aiming to accelerate the development and, ultimately, distribution of a safe and effective vaccine, which researchers hope will save lives.
“COVID-19 is affecting absolutely ever yone right now, and ever yone wants to get back to a more normal life,” Luckasen said in the release. “If we are able to develop a successful vaccine, the quicker we do it is going to be better for ever yone.”