KU Med And Children’s Mercy To Lead Clinical Trials Of Promising COVID-19 Vaccine
The trials, set to start by late August, could prove to be an important development in the medical response to the pandemic.
A COVID-19 vaccine developed by Oxford University and pharmaceutical giant AstraZeneca will be tested locally as part of a clinical trial seeking to enroll 30,000 participants nationwide.
The University of Kansas Medical Center and Children’s Mercy Hospital will lead the local effort, which calls for the recruitment of 1,500 participants in Kansas and Missouri.
Known as AZD1222, the vaccine generated an immune response in a study of 1,077 patients, according to interim results published in The Lancet medical journal on July 20.
More than 100 COVID-19 vaccines are currently in development, but AZD1222 has been one of the first to move into large-scale clinical trials.
The data published in The Lancet showed that the vaccine caused a variety of side effects in 60% of the participants. But those side effects — including fever, headaches, muscle aches and fatigue — were deemed mild or moderate.
“This vaccine is very exciting,” said Dr. Mario Castro, a pulmonologist with the KU School of Medicine. “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.”
Castro and Dr. Barbara Pahud, an infectious disease specialist at Chidren’s Mercy, will serve as co-principal investigators for the local trials.
AZD1222 is entering Phase 3 of clinical trials, meaning the vaccine — having cleared earlier stages of investigation — is given to thousands of people to see how many become infected compared with volunteers who receive a placebo.
The Phase 3 trials are expected to begin in mid- or late August. Participants must be over the age of 18 and considered to be at high risk of coming into contact with the novel coronavirus that causes COVID-19. The participants will be randomized; two out of three will get the vaccine and the rest will get a placebo.
According to the National Institutes of Health, Phase 3 clinical trials for another vaccine under development by Moderna Inc., a biotechnology company in Cambridge, Massachusetts, have also begun across the country. Like the AZD1222 trials, those trials are expected to enroll approximately 30,000 adult volunteers nationwide.
The Washington University School of Medicine and the St. Louis University Center for Vaccine Development are leading regional clinical trials for the Moderna vaccine.
That vaccine, which has also shown promise, uses messenger RNA, or mRNA, to prompt cells to make a fragment of the virus, which primes the immune system to attack if it encounters the real coronavirus.
By contrast, AZD1222 uses a genetically engineered virus taken from chimpanzees that carries a gene for one protein in the coronavirus. The virus is inserted into patients’ cells, causing them to manufacture that protein, which in turn triggers an immune response.
"Safety is our No. 1 priority," said Pahud of Children's Mercy Hospital. "I would not offer this vaccine if I were not ready to take it myself."
People wanting to be considered for the AZD1222 clinical trial and receive the vaccine can register using the Coronavirus Prevention Network website or by calling 913-574-3006 in Kansas City, 316-293-1833 in Wichita.