FARGO - Fargo-based Lillestol Research is signing up potential participants for a COVID-19 vaccine trial.
The two-year clinical research study “is evaluating an investigational vaccine for COVID-19 in healthy adults” ages 18 to 85, the company’s website said. The study requires a total of five on-site visits.
"We're participating in one of the large Phase 3 vaccine trials. and this one is for an RNA vaccine candidate," Jamie Brown, director of operations and a physician assistant at Lillestol confirmed Friday, Aug. 7. She declined to name the company or partnership developing the vaccine.
"It's an RNA (ribonucleic acide) vaccine. It's not a live vaccine. So, you cannot get the virus by getting the vaccine," Brown said.
A phase 3 trial is the largest clinical trial when a vaccine or medication or medication is going through clinical development.
"It's the largest trial that's done before it can be submitted for FDA approval. Typically it's in the thousands for numbers of patients. This one will be upwards of around 30,000 patients. We are just one site of many in the country doing the trial. Our goal is to enroll several hundred patients in an eight-week period of time," Brown said.
"It will be randomized. It will be like a flip of a coin whether a patient gets the vaccine or placebo. It's double blinded ... so our staff and the patient will be blinded to the treatment" the patient is getting, she said.
The New York Times reported Friday, Aug. 7, that nearly 160,000 people have died in the U.S. after being infected by the novel coronavirus. More than 4.8 million people have been confirmed to have been infected.
The North Dakota Joint Information Center reported Friday that the state's death toll had climbed to 110 as of Thursday due to COVID-19.
The Minnesota Department of Health reported Friday that the state’s death toll due to the coronavirus was 1,640. Of those dead, 1,241 lived in long-term care or assisted living facilities.
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Lillestol’s recruitment notice said that participants will be compensated for their time and will receive study-related medical care without charge. It added that there will be no overnight visits.
"We have a long-standing relationship with the sponsor of the study," Brown said. Lillestol was approached to take part in the study, which is typical, she said.
Like other clinical research, it is a volunteer study.
"Subjects will get paid for their participation, although it's usually no large amounts of money in these types of trials. But they do get compensated for their time and everything that is part of the trial is provided for free," Brown said.
Lillestol is looking for healthy adults age 18 to 85 to take part. Study participants can have underlying health conditions, as long as they are stable, Brown said. The participants also have to be at risk for the virus, which means they are out in the community in some way or another, such as working outside of the home or going to stores, or if they have underlying risk factors for COVID-19, such as being 65 or older or having underlying health conditions such as diabetes, high blood pressure, or if they are smokers.
Study participants cannot previously have had confirmed postive COVID-19 tests, Brown said.
If people are interested in being part of the study, they can go to the Lillestol Research website and sign-up online, or call 701-232-7705
Lillestol Research, 4450 31st Ave S., is one of many U.S. companies involved in Operation Warp Speed.
According to the Department of Health and Human Services, Operation Warp Speed aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. That effort is part of a broader strategy to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.
The World Health Organization reports that there are 26 vaccines around the world that are in clinical evaluations as of July 31. Another 139 vaccines are in preclinical evaluations.