Want to help test a COVID-19 vaccine? A clinical trial is open in the Treasure Valley
The Boise area is now a vaccine study site for COVID-19.
Solaris Clinical Trials in Meridian is enrolling volunteers in clinical trials of a coronavirus vaccine developed by Pfizer and BioNTech.
The Pfizer/BioNTech vaccine is one of several candidates to be fast-tracked through the federal approval process.
The Treasure Valley is one of 39 sites in the U.S. for this phase of the fast-tracked process.
The COVID-19 vaccine study in which Solaris is participating is placebo-controlled and double-blind, which means volunteers won’t know whether they have received the vaccine or a placebo, and neither will the clinical staff who give the injection.
“We’re looking for several hundred patients to participate in this trial” from the Treasure Valley area, said Dr. David Butuk, principal investigator. “We’re very excited and very honored that Pfizer chose our site. ... It’s a big deal.”
Butuk said he expects to start enrolling patients this week. While clinical trials usually need to advertise to recruit patients, he said Solaris has already been contacted by people who want to try the vaccine and has scheduled them for an initial visit.
The study is seeking volunteers ages 18 to 85 who aren’t pregnant, are generally in good health, haven’t already been diagnosed with or tested positive for COVID-19 but are at risk of the coronavirus infection.
Volunteers will receive two injections about three weeks apart. They will have follow-up visits over a two-year period and be asked to report any changes in their health.
The study expects to test the vaccine on 30,000 volunteers nationally.
Testing began in April with combined phase 1 and phase 2 trials, to figure out if the vaccine was safe and find the appropriate dose. It is now in a combined phase 2 and phase 3 trial, to find out how effective and durable the vaccine is in protecting a person from COVID-19.
“It is a true phase-3 study, in that they feel confident about the safety in humans for the actual vaccine, and also (about) the dosing that is most effective,” Butuk said. “Phase 3 is to show long-term safety, but also a key question would be how long does (immune protection last)?”
Volunteers will not be charged for the injections or the follow-up visits. They can be reimbursed for time, travel and expenses.
The U.S. government has already placed a $1.95 billion order for 100 million doses of the vaccine. The companies developing the vaccine expect to seek regulatory approval as early as October, while the study is still in process, and to start manufacturing doses by the end of the year, according to a July news release.
To find out if you qualify for the study, visit the Solaris website — solarisclinicalresearch.com/current-trials.html — or call (208) 288-0123.
This story was originally published August 10, 2020 at 4:00 AM with the headline "Want to help test a COVID-19 vaccine? A clinical trial is open in the Treasure Valley."
