Vaccine trial looking for local recruits
UPMC and the University of Pittsburgh said Wednesday they have begun recruiting 750 volunteers for coronavirus vaccine trials, making Pittsburgh one of 87 locations around the country taking part in the global effort to stop the infectious disease.
The recruitment effort is part of the national COVID-19 Prevention Network and Operation Warp Speed, which seek to accelerate the creation of a safe and effective vaccine to prevent people from getting the deadly COVID-19 disease.
The first trial that volunteers will be recruited for is a Phase 3 trial to test an RNA-based vaccine developed by Moderna Inc. On Tuesday, Moderna published the results of its Phase 1 trial among a small group of volunteers who showed just mild side effects and the development of antibodies that could fight off the virus that causes COVID-19.
The Cambridge, Mass., company was the first American firm to begin clinical trials of a COVID-19 vaccine, though there are at least 162 others around the country and the globe, including three vaccine efforts underway at Pitt. At least 23 of the global efforts, including Moderna’s, already are in clinical evaluation.
Because of the success of Phase 1 and Phase 2 trials,
Moderna announced it is moving forward with Phase 3, to begin July 27 with 30,000 volunteers across the United States selected through 87 locations, including Pittsburgh.
“Pittsburgh has been selected to be one of these sites. It’s really due to the expertise of our community and the infrastructure we have here at the University of Pittsburgh,” Dr. Judy Martin, director of the Pittsburgh Vaccine Clinical Trials Unit at UPMC Children’s Hospital of Pittsburgh and director of the Moderna vaccine trial locally, said at an online news conference. “So we’re really honored to be part of this Operation Warp Speed.”
Pitt and UPMC also are already preparing for a second clinical trial that will also require volunteers for an as-of-yet unidentified vaccine effort.
“We’re hopeful that we’ll be selected to participate in a third trial and perhaps more beyond that,” Dr. Sharon Riddler, who will direct the second vaccine effort and is Pitt’s director of clinical research in the university’s Division of Infectious Disease, said during the news conference.
The 750 people who are sought by Pitt and UPMC will cover just the first two trials — Moderna’s and the unnamed project Dr. Riddler is overseeing. If Pittsburgh is selected for still other trials, more volunteers will be recruited, Dr. Martin said.
Though Pitt and UPMC are regularly involved in vaccine trials, Dr. Martin said as far back as March, realizing that the effort to create a vaccine for the coronavirus that causes COVID-19 would potentially require many more volunteers than any other local effort in the past, she and her colleagues began setting up a vaccine volunteer registry website.
The registry “is set up for many different types of vaccines,” Dr. Martin said. “But, of course [COVID-19] is the most important one right now.”
The registry was opened two months ago and already has about 700 volunteers, not all of whom would be eligible to participate in the coronavirus trials. Dr. Martin and Dr. Riddler encouraged more people to register.
To volunteer for the trials, people need to be 18 or older and not immunocompromised. Pitt and UPMC hope to get people who work in higher-risk jobs or living situations where they would potentially be more exposed to COVID-19, including people who live in densely packed housing, restaurant and grocery store workers, public transit drivers, health care workers, or day care and school teachers.
Other high risk groups — such as Black and Latino populations, older adults and people with underlying health conditions — are also sought-after volunteers.
Volunteers will be randomly assigned either the vaccine or a placebo — made up of saline — injection. The initial injection may be followed by a booster shot four weeks later. Neither the volunteer, their clinician, nor the researchers will know if a volunteer received the vaccine or placebo. The volunteers will be followed for one to two years with periodic blood tests to see if their immune systems are producing antibodies to fight the virus.
You can volunteer either by emailing the trial directors at VTEU@chp.edu, calling 412-692-7382, or visiting their website at https:// www.chp.edu/research/ clinical-studies/generalacademic-pediatrics/ pittsburgh-vaccine-unitregistry.
Though the current global goal is to get an effective vaccine out to the world much quicker than two years from now, Dr. Riddler said even if the Moderna trial or any other was found to be effective and moved to full production earlier than that, volunteers would still be followed by the researchers for two full years at least.
Volunteers “would be followed for two years so we’re capturing or observing any safety concerns that have occurred over that longer time frame,” she said. “Also, there is great interest in whether that antibody response [of the body’s ability to fight the coronavirus off] decreases over time.”
While there were specific infrastructure reasons that Pittsburgh was chosen as one of the locations for the national vaccine trial network, Dr. Martin said history was also on the region’s side.
“Pittsburgh really has a long tradition of vaccine research starting in the 1950s with Jonas Salk and the polio vaccine,” noted Dr. Martin, who also is a professor of pediatrics at Pitt. With the Moderna trials, “Western Pennsylvania has another opportunity to participate in these research studies, which are really going to make a huge difference, both in our local community, as well as nationwide and across the world. This really allows us to do something that enables us to help.”