UMass Medical School is enrolling healthy volunteers to take part in a Phase II/III clinical trial testing whether a messenger RNA (mRNA) vaccine candidate can prevent infection with the virus that causes 2019 coronavirus disease (COVID-19). 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.
According to Robert W. Finberg, MD, the Richard M. Haidack Professor in Medicine and chair and professor of medicine, 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, non-pregnant adults 18–85 years old to participate in a randomized, observer-blind study of the safety, immune response and efficacy of the vaccine. In a blind trial, half the participants will receive the vaccine and the other half receive a placebo; no one—neither the volunteers nor the research staff conducting the trial—know whether a participant received the vaccine or the placebo. “We plan to reach out to areas where there are populations at higher risk for contracting COVID and look to enroll healthy volunteers from a diverse range of communities,” said Dr. Finberg. Participants in the trial will be given two doses of either the vaccine or the placebo at UMass Medical School’s clinical research center on its Worcester campus, with periodic follow-up visits over the next two years.
Based on information from the trial so far, the trial vaccine has not shown any severe reactions, said Finberg. “A good percentage of people do get a sore arm and some people may get a fever or body aches, but no severe side effects.”
“I think what we will know by the fall is whether people make antibodies in response to the vaccine. We think it is likely that they will, because that’s what all the previous vaccine studies show. Whether that means the vaccine is effective in preventing the disease will probably take longer to find out. “
Finberg stressed that safety will be closely monitored, and that the trial is placebo-controlled, which is the most definitive way of determining if a vaccine is both safe and effective.
“People should know it’s a placebo controlled trial, because that’s how science works. That’s how you obtain results that are real and durable. The goal of the trial is to prepare a safe and effective 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.
People interested in participating in the study can contact Jaclyn Longtine via email at Jaclyn.longtine@umassmed.edu or by phone at 508-856-5472. More information about the trial is available at https://live.covidvaccinestudy.com/