KU Med Resumes Clinical Trials For COVID-19 Vaccine

The University of Kansas Medical Center has resumed Phase III clinical trials of a COVID-19 vaccine that was halted last month after an enrollee in the United Kingdom developed an adverse reaction.

“We literally just got released by the FDA on Friday and then yesterday we got released from the IRB [Institutional Review Board], so we couldn’t start actually enrolling until today,” said Dr. Mario Castro, vice chair for clinical and translational research at KU Med and a co-principal investigator for the local trials.

The trials had barely gotten underway when the AZ1222 vaccine developed by the University of Oxford and purchased by drug maker AstraZeneca was temporarily paused late last month. But after the FDA reviewed safety data from trials around the world, it concluded last week that it was safe to resume them.

KU, along with its partner in the trials, Children’s Mercy Hospital, hopes to enroll 1,250 volunteers. So far they’ve enrolled five.

“We’ve got a ways to go,” Castro acknowledged, adding he was hopeful the hospitals could reach the target number in the next 60 days.

“The important thing is that we enroll the at-risk population that is being impacted by COVID-19. So we’re targeting that at least 25% of our enrollees will be elderly over the age of 65, at least 20% African American involvement and 20% Hispanics,” Castro said.

AZ1222 uses a genetically engineered virus taken from chimpanzees that carries a gene for one protein in the novel coronavirus, the cause of COVID-19. The virus is inserted into patients’ cells, causing them to manufacture the protein, which triggers an immune response.

A Different COVID-19 Trial at KU Med

Another trial underway at KU is not for a vaccine but for a drug to treat outpatients experiencing mild to moderate COVID-19 symptoms. That trial, called ACTIV-2, involves the use of monoclonal antibodies that target the spike proteins of COVID-19.

The drug is made by Eli Lilly, which is ending a clinical trial of a related drug for hospitalized COVID-19 patients after researchers concluded it did not produce significant improvement.

Castro said KU was actively enrolling volunteers for the outpatient treatment.

“If this works it would be tremendous because not only would we have a treatment for these patients, but we would also potentially change the long-term consequences of having a COVID-19 infection,” he said.

“ … So I’m very hopeful that this ACTIV-2 study will give us a tool to hit COVID-19 when it’s in a much milder stage and prevent those long-term complications.”

KU hopes to enroll 50 to 60 patients for that trial. Right now, 11 patients are enrolled.