UIC Prepares To Begin Phase III Trial Of Moderna Coronavirus Vaccine

Coronavirus

CHICAGO (CBS) — A key to ending the coronavirus pandemic is to create an effective vaccine and give it to as many people as possible.

Within a matter of days, an important step toward that mission will be taken at the University of Illinois at Chicago.

Researchers there will be giving trial vaccines to a thousand people.

Joining CBS 2’s Irika Sargent Tuesday to talk about the Phase 3 clinical trial soon to start at UIC was the lead investigator in the trial, Dr. Richard Novak.

UIC will be undertaking part of the Phase 3 trial of a vaccine produced by Moderna. Last week, the company said its mRNA-1273 vaccine has induced immune responses in all volunteers in its initial Phase 1 study, just the way scientists would hope.

The vaccine induced binding antibodies to the coronavirus spike protein after the first vaccination, a Moderna news release said.

The vaccine requires two doses, a month apart. It was given 28 days apart beginning in March, in three dose levels to 45 healthy participants between the ages of 18 and 55.

Dr. Novak will oversee the Phase 3 trial at UIC. The 1,000 participants in Chicago will either receive the vaccine or a placebo, and be monitored throughout.

Novak said the potential vaccine had not yet arrived at the university as of Tuesday.

“We don’t have it in house yet. We’re still waiting for delivery, and we’re still missing a few pieces to get the vaccine trial up and running,” he said.

Once the trial does start, Novak and his team will be observing how many people are infected.

“We anticipate that the study will go for a minimum of six months. It’s scheduled for two years. It really is dependent on how many cases we get in the vaccine participants, because as you know, the study is designed so that half the people get a placebo, which is saltwater, and the other half will get the vaccine. And in the end, we want to see fewer cases of infection in the vaccine recipients than the placebo,” Novak said. “But in order for us to see that, we have to see a certain number of infections. So the rate of new infections is largely going to drive how quickly we get the answer to this study.”

Novak said a delay to the start of the trial is possible since the vaccine has not arrived.

“We’re largely dependent on the government and Moderna to get this study up and running for us,” he said.

Meanwhile, thousands of people have signed up for the vaccine trial. There is a process in determining who gets it.

“There are certain criteria that we’re looking for in people for them to participate. We do have many thousands of people who are interested. We’re trying to find people who are particularly at risk for getting COVID-19 disease by virtue of the part of town they live in, or what kind of work they do, or their living situation,” Novak said, “but also, we’re looking for people who, if they get COVID-19 disease, do they get really sick with it? So we’re looking at a group of people who are older or possibly not as old, but have some underlying illness, at least in a subgroup of the people who enroll.”

Novak said the study is a tremendous amount of work and a “24/7 occupation, but we’re excited because we’re very hopeful this trial will be successful.”

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