UW seeks 2,000 people for COVID-19 vaccine trial.
2,000 participants set to receive injection
A crucial Phase III clinical trial of a vaccine against COVID-19 begins this week at the University of WisconsinMadison School of Medicine and Public Health and its teaching hospital UW Health.
On Tuesday afternoon, the first of an expected 2,000 participants in the trial will be injected in the shoulder, either with the vaccine developed by the English drug company AstraZeneca, or with a harmless placebo. The trial of the vaccine, known as AZD1222, is taking place at scores of sites around the world.
“It’s kind of a pivotal moment in attacking COVID-19,” said William Hartman, an assistant professor of anesthesiology who will lead the UW portion of the trial. “We’ve focused on treatment up to this point.
“It’s an honor for UW now to be able to contribute to the effort to find a vaccine, to do our part in helping bring the world back to normal.”
The vaccine being tested uses a weakened virus that causes the common cold in chimpanzees. That virus has been manipulated to include the gene that produces the all-important spike protein in the new coronavirus.
The spike protein allows the virus to dock onto the cells lining the human upper respiratory system. That’s how the virus enters our cells and begins to spread.
Once injected into a person, the vaccine will make a piece of the new coronavirus, triggering the body’s immune system to produce antibodies and T cells, a major component of the immune system.
Hartman said UW hopes to recruit 250 patients a week for eight weeks to participate in the trial. Researchers will inject all trial participants once on the first day and a second time on Day 29. All participants will then be monitored for two years.
Participants will be monitored and will undergo periodic tests, including physical exams, measurements of vital signs and COVID-19 tests. They are not exposed to the virus, but left to go about their day-to-day lives.
Earlier clinical trials of the AstraZeneca vaccine, carried out on more than 1,000 people, found that it triggered the production of antibodies in about 85% and T cells in more than 90%. Side effects included muscle aches and fever, and generally occurred in the first 24 hours.
According to the Centers for Disease Control and Prevention, more than 200 vaccine candidates for COVID-19 are under development around the world; four are in clinical trials in the U.S.
Vaccine development can take 10 to 15 years, but regulators have accelerated the process this year in hopes of producing a vaccine that can be put into widespread use much sooner.
The Phase III vaccine trial beginning at UW is randomized, double-blinded and placebo-controlled, a design considered “the gold standard” for scientific accuracy.
To participate in the trial, people must be at least 18 years old, healthy and with no evidence of prior COVID-19 infection. Study organizers will interview applicants for the trial. Names of those who qualify be sent to a central comput
er run by AstraZeneca, which will assign them a number.
Participants will provide their number to the pharmacy, which will then assign them to receive either the vaccine or the placebo; participants won’t know which.
Two-thirds of participants will receive the vaccine; one-third will get the placebo. Neither the study subjects and researchers will not know who has received the vaccine and who has received the placebo.
“If you see a lower rate of COVID-19 infection in those who have received the vaccine, you can then comfortably say that the vaccine caused them to have a lower risk of getting the virus,” Hartman said.
Jennifer Parnell, director of the UW Office of Clinical Trials, said it took more than 100 staff to organize the UW branch of the trial.
She said the vaccine is being tested on roughly 30,000 people at 99 sites in the U.S., as well as in other sites around the world.
“Fundamentally we are in the middle of a worldwide pandemic and it’s up to all of us to help,” she said, explaining her pitch to potential participants. “The vaccine might help you, yes. But there’s a greater good here, not just to the U.S. but to the world.”
Anyone interested in taking part in the vaccine trial can email: uwcovidvaccine@clinicaltrials.wisc.edu or call 608-262-8300. More information is also available: https://www.c19.vaccinestudy.com/.
The university is also hosting trials of several potential COVID-19 treatments. A drug called ruxolitinib is being tested on some of the most critically ill COVID-19 patients.
UW Health is hosting three trials testing cocktails of lab-manufactured antibodies against COVID-19. The cocktails have been made by the drug company Regeneron Pharmaceuticals, headquartered in Tarrytown, N.Y.
UW Health has also been treating COVID-19 patients with the drug remdesivir and with plasma from those who’ve recovered from the disease.