Rutgers faculty discusses U. participation in coronavirus vaccine trials
Shobha Swaminathan, associate professor in the Department of Medicine at the Rutgers New Jersey Medical School and medical director of the infectious disease practice at University Hospital in Newark, is the site director for the Moderna clinical trials.
Rutgers has been selected as the site of two different clinical trials to find a vaccine for the coronavirus disease (COVID-19).
“We were selected as a site for the phase 3 study of the Moderna vaccine trial a few weeks ago, and for the Johnson & Johnson vaccine trial last week,” said Brian Strom, chancellor of Rutgers Biomedical and Health Sciences.
Of the 38 vaccines undergoing human testing, nine are being tested in large scale trials, according to The New York Times.
The purpose of these trials is to uncover a safe and effective vaccine that will help induce immunity in the hosts, said Shobha Swaminathan, associate professor in the Department of Medicine at the Rutgers New Jersey Medical School and medical director of the infectious disease practice at University Hospital in Newark. Swaminathan is the site director for the Moderna clinical trials.
“Depending on the study, the vaccines can look at the number of symptomatic cases in the vaccine compared to the placebo. Some may also look at the impact of the vaccines in reducing the severity of illness in those vaccinated compared to placebo,” Swaminathan said. “Others may potentially look at the prevalence lower respiratory tract involvement in active versus placebo. Clinical trials will also be looking at the level and duration of antibody titers and other markers of immunity to COVID-19 over time.”
Strom said there are approximately 100 sites in each trial. The Moderna study is recruiting 30,000 subjects and the Johnson & Johnson study is recruiting 60,000 subjects, he said.
“As of Sept. 4, over 21,411 participants have already enrolled across the United States in the Moderna Phase 3 study,” Swaminathan said.
Participants in the trials must be over the age of 18 with no underlying health issues, said Jeffrey L. Carson, the New Brunswick provost at Rutgers Biomedical and Health Sciences and member of the Johnson & Johnson clinical trials.
Swaminathan said the Moderna study is prioritizing volunteers who are elderly or essential workers, as well as racial and ethnic minorities at high risk for contracting COVID-19. Also, participants cannot have any history of SARS-CoV-2 infection, the coronavirus that causes COVID-19 or previous participation in an investigational coronavirus vaccine, she said.
“Manufacturers want to be sure the trials include a representative population, and (New Jersey’s) diverse population was attractive to them. In addition, Rutgers has done an enormous amount of COVID-19 research, including creating the largest healthcare worker cohort study,” Strom said. “We also provide medical care to workers in prisons and other groups. These are all high risk of getting the disease, which make them useful candidates for possible volunteers for these trials.”
Swaminathan said participation in these clinical trials are voluntary and optional. Participants are required to provide informed consent and are able to stop participation at any time, she said.
In order to participate, Swaminathan said individuals should reach out directly to study staff to enroll. Recruitment will be completed within the next two weeks and participants will then be followed for 25 months, she said.
Strom said participants in the Moderna study will receive the first injection and will be followed for a month. There will then be a prolonged follow-up after participants receive their second injection, which will last years. After they receive their second injection, there will be a prolonged follow-up - years after they receive the second injection.
“The (Johnson & Johnson) trial has not started yet but is tentatively scheduled to begin Sept. 21,” Carson said. “Once the trial begins, those interested can go to the trial website to volunteer.”
As opposed to the Moderna trial, Strom said the Johnson & Johnson vaccine only needs to give participants one shot and will follow individuals for a prolonged period.
When it comes to the risks of the trials, Carson said researchers do not know if the vaccine is effective or if there will be side effects.
“Currently, the enrollment into (the Moderna) Phase 3 vaccine studies is only possible (due to) information from earlier Phase 1 and 2 studies,” Swaminathan said. “There is an independent committee that reviews the safety for all participants in the prior studies.”
Carson said it is difficult to estimate how long it will take for effective vaccines to be found with acceptable side effects. He said it will likely take months before a vaccine is administered to a large number of people.
“Finding a safe and effective COVID-19 vaccine will be the first step in helping our community begin the recovery process from the COVID-19 pandemic. If people get vaccinated after its approval, it will hopefully allow our schools to reopen, small businesses to become operational and our senior citizens who have been living in fear to live a normal life again,” Swaminathan said. “Ensuring complete transparency in the process and reassuring the public about the integrity of the clinical trial process is critical to ensuring that the public has faith in the results of the study.
