The Moderna vaccine — which just announced a successful phase one trial and is one of the furthest along so far in the race for a COVID-19 vaccine — is coming to Pittsburgh.
“These clinical trials are part of what’s been called Operation Warp Speed by the U.S. government, which is a national initiative to accelerate development of a safe and effective vaccine to protect participants or recipients from the SARS-CoV-2 virus and COVID-19,” said Dr. Sharon Riddler, director of clinical research for Pitt’s Division of Infectious Diseases, during a press conference on Wednesday. They expect to begin the first vaccine study by Moderna in late July.
Locally, Pitt and UPMC hope to recruit 750 participants over age 18, who are not severely immunocompromised. They’re looking in particular for people who have a higher chance of being exposed to the virus, due to their jobs or activities, such as people living in more densely packed housing environments, restaurant and grocery store workers, public transit drivers, health care workers, or daycare and school teachers.
“Participating in Operation Warp Speed is a huge honor,” said Dr. Judy Martin, director of the Pittsburgh Vaccine Clinical Trials Unit at UPMC Children’s Hospital of Pittsburgh, who is leading the site for the Moderna vaccine. “This is a chance for Pittsburgh to have an impact that’s not just local or national — it’s going to be worldwide. One of these vaccines will likely be successful — and hopefully more than one.”
“Recruitment of volunteers to participate in research studies here in Pittsburgh begins immediately,” said Riddler. “And we’re expecting the first vaccine study … to begin in late July. This will be led by Judy Martin, followed quickly by other candidate vaccines. So, we’re expecting more than one trial to open in Pittsburgh.”
Half the participants will receive the vaccine and the other half a placebo saline injection. The participants will not know which one they have received until the end of the study. Each participant will get an immunization, and then a booster shot four weeks later. They will be followed for one to two years to see if their immune systems are producing antibodies specific to the virus.
The study is funded in part by the Richard King Mellon Foundation. “Pittsburgh has been at the center of global healthcare innovation for decades, and it is only fitting that we be part of the efforts to find a vaccine for COVID-19,” said Foundation Director Sam Reiman. “The Foundation has been partnering with UPMC since its inception, and we wanted to be part of this essential effort as well.”
Riddler will lead the Pittsburgh site for a second, yet-to-be-announced vaccine candidate.
“We hope that people who belong to communities that have been disproportionately affected by COVID-19, such as Black and Latino populations, individuals who are older and people with underlying health conditions, will participate and those individuals have been given a higher priority for enrollment into the studies,” said Riddler.
The vaccine from Cambridge, Massachusetts-based biotech firm Moderna uses synthetic messenger RNA to deliver instructions to cells, which instruct them to produce SARS-CoV-2 proteins, provoking the immune system to respond and defeat the full virus in the future. The vaccine has been cleared by the U.S. Food and Drug Administration for Phase III clinical trial with thousands of people across the country.
“Yesterday, Moderna reported promising results of their phase one trial in The New England Journal of Medicine,” said Martin. “These results demonstrate some mild side effects with the vaccine administration.
“Importantly, they also demonstrate that the participants in this first research study demonstrated antibodies to the SARS-CoV virus, which would enable them to neutralize that virus. So it’s really because they’re bolstered by these Phase I study results … that they are going to the next step. So these Phase III trials will be conducted nationwide and Pittsburgh has been selected to be one of these sites.”
The study is funded by the National Institute of Allergy and Infectious Diseases and the Richard King Mellon Foundation, which awarded a $250,000 grant to the Children’s Hospital of Pittsburgh Foundation to help fund COVID-19 vaccine clinical trials.