Hundreds of people in Western Pennsylvania will have the opportunity to participate in clinical research trials for vaccines against the coronavirus that causes COVID-19, UPMC and the University of Pittsburgh announced today.
The trials are part of the COVID-19 Prevention Network and Operation Warp Speed, the national initiative to accelerate development of a safe and effective vaccine to protect recipients from SARS-CoV-2. Recruitment for the Pittsburgh site for the trials begins immediately, first for the vaccine being developed by Moderna Inc., followed quickly by other candidate vaccines.
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“Participating in Operation Warp Speed is a huge honor. This is a chance for Pittsburgh to have an impact that’s not just local or national – it’s going to be worldwide,” said Judy Martin, director of the Pittsburgh Vaccine Clinical Trials Unit at UPMC Children’s Hospital of Pittsburgh and professor of pediatrics at Pitt. “One of these vaccines will likely be successful—and hopefully more than one.”
Martin, who is directing the Pittsburgh site for the Moderna vaccine, and Sharon Riddler, director of clinical research in Pitt’s Division of Infectious Diseases, who is planning to direct the Pittsburgh site for a different, yet-to-be-announced vaccine, said the region was selected to participate in the trials because of its storied history in vaccine development, Dr. Jonas Salk’s leadership in developing a polio vaccine at Pitt, and Pitt and UPMC’s robust infrastructure and experience with running clinical trials.
“Pittsburgh has a tradition of being on the forefront of vaccine research,” said Riddler, who is also professor of medicine at Pitt. “Beyond that, people in Pittsburgh roll up their sleeves and do the work. We’re reliable and altruistic.”
Though they’ll be running separate trials testing different vaccines, Martin and Riddler are working together to ensure both trials fulfill their recruitment goals.
The Moderna vaccine uses synthetic messenger RNA to deliver instructions to cells telling them to produce some of the SARS-CoV-2 proteins, which provoke the immune system to respond, prepping it to quickly recognize and defeat the full virus in the future. It has been through smaller phase I and II human clinical trials to assess safety and determine that it provokes an immune response. The vaccine has been cleared by the U.S. Food and Drug Administration for a phase III clinical trial in thousands of people nationwide.
In total, the Pittsburgh site seeks to recruit 750 participants over age 18 who are not severely immunocompromised. Ideal participants are those who have a higher likelihood of being naturally exposed to SARS-CoV-2 due to their public activities or occupation, such as those living in more densely packed housing, restaurant and grocery store workers, public transit drivers, health care workers or daycare and school teachers. People who belong to communities that have been disproportionately impacted by COVID-19—such as Black and Latinx populations, older adults and those with certain underlying health conditions—will also be given priority consideration.
Participants will be randomly assigned to receive either the study vaccine or a placebo (saline) injection. Neither the participant, their clinician, nor the researchers will know whether the participant received the study vaccine or placebo. They will receive an initial immunization, which may be followed by a booster four weeks later. Participants will then be followed for one to two years with periodic blood tests to see if their immune systems are producing antibodies specific to the virus.
This work is funded by the National Institute of Allergy and Infectious Diseases and the Richard King Mellon Foundation, who last month awarded a $250,000 grant to the Children's Hospital of Pittsburgh Foundation to help fund the COVID-19 vaccine clinical trials.