UMass Medical School is reaching out to diverse communities in Worcester to recruit volunteers for its Phase II/III clinical trial of a messenger RNA (mRNA) vaccine candidate for the virus that causes COVID-19, according to reports in the Boston Globe and CNN. The trial, by Pfizer and BioNTech, follows review of preclinical and clinical data from a Phase I trial, which assessed safety, tolerability and immune response in a group of volunteers.
Robert Finberg, MD, the Richard M. Haidack Professor in Medicine, chair and professor of medicine and the primary investigator of the UMMS site for the vaccine trial, and Matilde Castiel, MD, associate professor of medicine at UMMS and commissioner of health and human services for the city of Worcester, told the Globe in the Monday, Sept. 7, edition that Latinos in Worcester are three times more likely to get COVID-19, while Blacks are more than twice as likely. A health equity task force was formed to address the inequities and Dr. Finberg asked the group to encourage participation in the study.
“For the good of the community, I’m going to take it,” Dr. Castiel told the Globe on Friday, Sept. 4, just prior to receiving an injection as part of the trial. Participants in the trial are given two doses of either vaccine or a placebo at the UMMS clinical research center on its Worcester campus, with periodic follow-up visits over the next two years.
Finberg told CNN on Monday, “We’re reaching out to those communities to try to get more and more people from diverse communities and also diverse age groups. We need to reach out to older people as well.”
In all, UMMS will enroll several hundred volunteers in the trial as part of a network of 120 centers seeking up to 30,000 healthy participants; about 15,000 have already been enrolled in sites around the world. The study will measure whether the vaccine candidate can protect against COVID-19 infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The Phase II/III study seeks healthy, nonpregnant adults 18–85 years old to participate in the randomized, observer-blind study of the safety, immune response and efficacy of the vaccine .The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.