UI Health COVID-19 Vaccine Study Now Open
Monday, August 24, 2020
Today, a handful of Chicago residents will be the first in the city to participate in a national clinical trial to test a potential vaccine against SARS-CoV-2, the virus that causes COVID-19.
The vaccine is an mRNA vaccine developed by Moderna, a Massachusetts-based biotech company. It is one of many vaccines in development but so far is one of the leading candidates being developed in the U.S.
The University of Illinois Chicago will lead the study in Chicago and enroll up to 1,000 people into the trial, which aims to understand if the vaccine helps to give people immunity or protection against the virus.
"We are looking for two things really," said Dr. Richard Novak, chief of the Division of Infectious Diseases at UI Health, who is leading the study. "One, we want to see if people who get the vaccine have a lower chance of getting sick from the virus compared to others - this would be game-changing. Two, for those people who still get sick from COVID-19, we want to see if those who received the vaccine have better outcomes. For example, if people with the vaccine have a lower chance of needing to be hospitalized when they do get sick, this would also be a really positive step forward and dramatically impact public health."
Participants will be assigned randomly to one of two groups: a study group, which will receive the vaccine, and a control group, which will receive a placebo. Neither the researchers nor the participants will know who gets the vaccine.
About 500 people will get the vaccine, which will be administered as a series of two shots over the course of four weeks. The other half of the participants will receive a placebo.
Today, only a handful of individuals will be enrolled in the study and receive a shot. Over the next few days, the research team will move as quickly as possible to schedule appointments with other volunteers, eventually administering the shots to anywhere from 20-40 people each day, at various locations, until the study closes.
"We will have two UIC locations and a site at the University of Chicago," said Novak. "We expect the study to enroll 1,000 people within the next month or so."
Trial volunteers will be asked to have an initial appointment with a research team member, six in-person follow-up appointments, weekly check-ins by phone, and to maintain an electronic diary. These follow-up measures will help the researchers to track participants' health and COVID-19 symptoms, like fever, cough, sore throat and body aches, for example.
During the initial appointments, blood will be drawn as part of a general health exam and patients will be tested for COVID-19. Additional testing and blood draws will be performed throughout the trial.
The researchers will follow the participants for two years, although Novak said early results from the trial may be available before that - as early as December is possible, he said, although it's not guaranteed.
So far, more than 8,000 people have volunteered for the study through the national registry and by contacting UIC and other trial sites directly.
"More than 2,000 people have contacted us directly, and we welcome people to keep volunteering - we want individuals in our trial to represent the many different community groups that live in Chicago," Novak said.
Novak said that he hopes the trial will include all races and that his priority is enrolling people who are considered high-risk for getting sick from COVID-19 or having poor outcomes, such as individuals who have pre-existing conditions, are older, or are members of vulnerable communities.
UIC is the only university in Chicago selected for this trial, which is being spearheaded by the National Institute of Allergy and Infectious Disease.
People interested in volunteering for the trial can sign up via UIC's online registry, which contains a two-part questionnaire, or the national registry. People can also call UIC researchers at 312.355.0656 with questions.