UIC opens second COVID-19 vaccine trial

The University of Illinois Chicago is now enrolling participants into a new phase 3 clinical trial to study a vaccine against SARS-CoV-2, the virus that causes COVID-19. 

The investigational COVID-19 vaccine candidate — named JNJ-78436735 but also known as Ad26.COV2.S — was developed by Janssen Pharmaceutical Companies of Johnson & Johnson. The goal of the randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the single-dose injection versus a placebo. 

The trial will include adults 18 years and older and the researchers aim to include significant representation from those who are over 60.

This is the second national COVID-19 vaccine trial to include UIC as a trial site. 

Dr. Richard Novak is the principal investigator of the clinical trial at UIC; he anticipates enrolling around 500 people into the UIC study. Globally, the trial, which is called the ENSEMBLE Study, aims to enroll around 60,000 individuals, around 30,000 of which will be in the U.S. 

“The Janssen vaccine candidate we are studying in this trial is a viral vector DNA vaccine that only requires one injection. If proven effective and safe, this candidate may be easier to administer than the other vaccines currently in the pipeline,” said Novak, UIC professor and head of infectious diseases at the College of Medicine. 

Novak says that having multiple vaccines approved and available to the public would be a good thing.

“There is a lot we need to learn about the vaccines currently being tested — as we continue to study the vaccine candidates and learn more about their efficacy, we want to look at which vaccines work best in which populations,” Novak said. “Part of that equation is to understand which vaccines are easiest to administer to large amounts of people. Another part is understanding if certain vaccines just work better for different kinds of people — if we find that one is more effective in the elderly or in communities of color, for example, that is really important information to know. We also need many companies to produce vaccines in order to provide for the entire population.”

The UIC clinical trial to study the Janssen vaccine candidate will follow participants for two years. Participants will have an initial intake appointment with the UIC researchers, at which time they will undergo a brief health exam for basic vital signs, health history will be documented, blood will be drawn and the injection — which will be either a placebo or the vaccine candidate — will be administered. 

Throughout the trial, participants may have periodic follow up appointments but mostly will track their health and any symptoms via an electronic diary. 

Neither the participants nor the researchers will know who received the vaccine and who received the placebo. 

“We will follow these participants and see if those who receive the vaccine are less likely to get the virus or get sick from the virus than those who receive the placebo,” Novak said. 

Inclusive recruitment for the clinical trial is also a priority, according to Novak. 

“We want the demographics of our study participants to mirror the demographics of our area and of our country. This is the best way to make sure we have vaccines available that will protect everyone,” Novak said.

ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority; and the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. 

Anyone interested in volunteering for the UIC trial can sign up via the national registry or call UIC researchers at 312-355-0656 with questions.