Rutgers is acting as a clinical trial site for the Janssen Pharmaceutica of Johnson & Johnson’s phase 3 clinical research study to assess the effectiveness of Janssen’s coronavirus disease (COVID-19) vaccine candidate, according to an article from Rutgers Today.
The goal of the study is to recruit 60,000 participants across the U.S. and other parts of the world, with 2,000 participants specifically from the Rutgers community, said co-lead investigator Jeffrey Carson, a distinguished professor in the Department of Medicine and provost at Rutgers Biomedical and Health Sciences.
“We’re trying really hard (to reach this number),” he said. “We're ramping up our recruitment processes, and at this point, we're recruiting (approximately) 40 to 50 people each day and we're building additional teams that should allow us to (achieve) close to double our recruitment.”
Approximately 15,000 participants are currently enrolled in the trial, Carson said. In order to be eligible, participants must be adults with no unstable medical issues and no active COVID-19 infection or other illnesses.
Participants are identified for the trial from a group of previous COVID-19 study volunteers who have agreed to be approached for future studies, those who have responded to emails sent throughout Rutgers and the Rutgers University Alumni Association and advertisement respondents, he said. There is also a website where people can go directly to express their interest in participation.
Carson said the team is working hard to obtain participants from diverse backgrounds for the trial, since many underrepresented minorities have some of the highest rates of COVID-19 infection.
Co-lead investigator XinQi Dong, Henry Rutgers distinguished professor of Population Health Science and director of the Institute for Health, Health Care Policy and Aging Research, said having a diverse sample of participants is important in order to ensure the vaccine is safe and effective for everyone.
“We need to understand, for example, if there are differences between older people and younger people, or between Blacks, whites, Hispanics, Asians and others,” he said. “At the Institute for Health, we work with communities to build trust in research and encourage participation among populations who are often underrepresented and underserved.”
Carson discussed the process of the trial and how it will be conducted.
Participants will first undergo informed consent, where they will be presented with details of the study as well as the potential risks and benefits, he said. After participants have given their consent, lab tests such as blood specimens, saliva and nasal swabs will begin to be collected.
From there, Carson said researchers will use a computer system to flip a coin and decide which half of the participants get a placebo and which half get the vaccine. The trial is designed to have 154 events with a two-month waiting period before following up with participants as part of the protocol, he said.
“If there's 154 events, then they can look at the results to see whether those who got the placebo had more COVID-19 (infection) in follow-up than those who got the vaccine,” Carson said. “And if that turns out to be the case, then that would suggest then that the vaccine was effective in preventing the development of COVID-19.”
After the trial is completed, the team will determine the vaccine’s efficacy and side effects, he said.
“The next step will be (to) establish that it works, compare it to other vaccines and then develop a huge supply so you can administer it around the world,” Carson said. “Then you're going to have to develop a plan for distribution and administration to large numbers of people.”