University of Kansas Medical Center and Children's Mercy to offer clinical trial of AstraZeneca vaccine for COVID-19
July 29, 2020
By Kay Hawes
The University of Kansas Medical Center and Children's Mercy Kansas City announced today that they will be leading the regional efforts of a nationwide clinical trial brought through the COVID-19 Prevention Network (CoVPN). The CoVPN was created by the National Institutes of Health (NIH) to respond to the growing coronavirus pandemic. The KU Medical Center and Children's Mercy collaboration will be testing the COVID-19 vaccine AZD1222, developed by Oxford University and purchased by AstraZeneca.
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 on The University of Kansas Health System daily media briefing (below).
"This vaccine is very exciting," Castro said. "There's been so much thrown at this coronavirus in terms of treatment and prevention, and we ultimately know that the best strategy for this virus is a vaccine."
Anticipated to launch in mid-to-late August, the phase 2/3 trial is funded by the National Institutes of Health and sponsored by AstraZeneca. This study is organized through the Fred Hutchinson Cancer Center, and there will be more than 100 sites nationwide. 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.
"We are working to develop and conduct studies to ensure rapid and thorough evaluation of COVID-19 vaccines," Pahud said. "Safety is our No. 1 priority. I would not offer this vaccine if I were not ready to take it myself."
The vaccine will be available regionally at multiple sites in partnership with KU School of Medicine-Wichita's Center for Clinical Research, which 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.
"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."
Plans call for the recruitment of 30,000 participants nationally, with around 1,500 from the Kansas-Missouri region. Adults over the age of 18 who are considered high-risk for coming into contact with 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.)
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.
"In fact, in over 1,000 patients, there were no serious adverse events reported, which is very heartening," Castro said.
To be considered for the clinical trial and receive the vaccine, adults may follow one of these options:
- Register at the Coronavirus Prevention Network website (providing the site preference as KUMC)
- Call for screening. In Kansas City, call Shelby at 913-574-3006. In Wichita, call 316-293-1833.