KU School of Medicine–Wichita
1010 N. Kansas
Wichita, KS, 67214
July 31, 2020
WICHITA, KANSAS - The University of Kansas School of Medicine-Wichita Center for Clinical Research will be leading the local effort of a nationwide clinical trial brought through the COVID-19 Prevention Network (CoVPN) testing the COVID-19 vaccine AZD1222, developed by Oxford University and purchased by AstraZeneca. Regional efforts and testing will be led by KU Medical Center and Children's Mercy Kansas City. The CoVPN was created by the National Institutes of Health (NIH) to respond to the growing coronavirus pandemic.
Locally, the vaccine will be available at the Center for Clinical Research and its mobile unit, which will travel to high-risk areas in Wichita and the surrounding region. The project will be overseen by Tiffany Schwasinger-Schmidt, M.D., Ph.D., director of the center and assistant professor in the KU School of Medicine-Wichita Department of Internal Medicine. Physicians from the department and staff in the Office of Research also will be assisting in conducting the trial.
"We are so excited to have assembled a strong partnership among researchers at KU and Children's Mercy to offer this vaccination to Kansans," said Schwasinger-Schmidt. "We know that prevention through vaccination will be key in stopping the spread and devastating effects of this virus."
Anticipated to launch in mid-to-late August, the phase 2/3 trial is funded by the NIH and sponsored by AstraZeneca. This study is organized through the Fred Hutchinson Cancer Center, and there will be more than 100 sites nationwide.
Plans call for the recruitment of around 1,500 participants from the Kansas-Missouri region. Adults over the age of 18 who are considered high-risk for encountering COVID-19 will be recruited into the study, and participants will be randomized to determine who receives the vaccine. Individuals who are staying home and drastically limiting contact with others likely will not be eligible. Two out of every three participants will receive the vaccine, with the third receiving a placebo. Once the trial is concluded, participants receiving the placebo will be eligible to receive the vaccine.
Mario Castro, M.D., MPH, Vice Chair for Clinical and Translational Research and pulmonologist at the University of Kansas School of Medicine Department of Internal Medicine and Director of Frontiers: University of Kansas Clinical and Translational Science Institute, made the announcement Monday, July 27, on The University of Kansas Health System daily media briefing.
Castro has partnered with Barbara Pahud, M.D., MPH, Research Director of Pediatric Infectious Diseases at Children's Mercy and Clinical Associate Professor of Pediatrics at the KU School of Medicine, to offer this trial in the region. Castro and Pahud will serve as co-principal investigators.
Castro said results of a pilot study of this vaccine were published recently in the prestigious medical journal, The Lancet, and showed promising results on more than 1,000 clinical trial participants. Side effects appear to be mild as well, with mostly headaches, body aches and fatigue reported. Within these participants, there were no serious adverse events reported.
"Patient safety regarding this trial is our number one priority," said Schwasinger-Schmidt.
To be considered for the clinical trial and receive the vaccine, adults may follow one of these options: