UW Health and the University of Wisconsin School of Medicine and Public Health (SMPH) are among the first sites in the country to study whether an investigational vaccine developed by the pharmaceutical company AstraZeneca can prevent COVID-19, the disease caused by the new coronavirus SARS-CoV-2.
“UW Health and SMPH are proud to be at the forefront of working toward identifying safe, effective solutions to this global pandemic,” says Betsy Nugent, chief clinical research officer at UW Health and SMPH. “Our entire team has been working diligently for months to bring this important clinical trial to our state, and now Wisconsinites have an opportunity to be part of solving this crisis.”
The study, which is recruiting participants, is a phase 3 randomized, double-blinded, placebo-controlled clinical trial – the gold standard for measuring the efficacy of investigatory drugs. UW is one of 100 clinical sites around the country to participate in the trial and will enroll approximately 1,600 people over the next eight weeks at University Hospital.
Participants will be randomly assigned to receive two injections of either the investigational vaccine (also known AZD1222) or a placebo designed to look like the investigational vaccine but containing no active vaccine. Participants are twice as likely to receive the investigational vaccine than the placebo.
Following the treatment, the study will last approximately two years and enrollees will periodically undergo tests to monitor their health. This includes physical examinations, measurements of vital signs such as blood pressure and heart rate, blood tests, and COVID-19 testing.
Results published recently in The Lancet from the previous two phases of the clinical trial show that the AstraZeneca investigational vaccine delivered strong immune responses in all participants.
To be eligible for the next phase, participants must be at least 18 years old, healthy or have medically stable chronic diseases. They also cannot have a previously confirmed diagnosis of COVID-19. The screening, treatment, and follow-up will all take place at University Hospital in Madison. Participants will receive the injections and study-related medical care from UW Health doctors at no cost.
Approximately 30,000 participants will take part in this study nationwide. The UW Health arm of the study is led by Dr. William Hartman, assistant professor of anesthesiology at SMPH.