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 the development of a safe and effective vaccine to protect SARS-CoV-2 recipients. Recruitment for the Pittsburgh site for trials begins immediately, first for the vaccine developed by Moderna Inc., quickly followed by other candidate vaccines.
“Participating in Operation Warp Speed is a great honor. This is an opportunity for Pittsburgh to have an impact that is not only local or national, but will be worldwide, ”said Judy Martin, director of the Pittsburgh Vaccine Clinical Trials Unit at UPMC Children’s Hospital in Pittsburgh and professor of Pitt pediatrics. “One of these vaccines is likely to be successful, and hopefully more than one.”
Martin, who runs the Pittsburgh site for the Modern vaccine, and Sharon Riddler, director of clinical research in Pitt’s Division of Infectious Diseases, who plans to run the Pittsburgh site for a different vaccine, yet to be announced, the region said. Selected to participate in trials due to its historical track record in vaccine development, Dr. Jonas Salk’s leadership in developing a polio vaccine in Pitt, and Pitt and UPMC’s strong infrastructure and experience with trial execution clinicians.
“Pittsburgh has a tradition of being at the forefront of vaccine research,” said Riddler, who is also a professor of medicine at Pitt. “Beyond that, people in Pittsburgh roll up their sleeves and get the job done. We are trustworthy and altruistic. “
Although they will conduct separate trials testing different vaccines, Martin and Riddler are working together to ensure that both trials meet their recruitment goals.
The Modern vaccine uses synthetic messenger RNA to deliver instructions to cells telling them to make some of the SARS-CoV-2 proteins, which cause the immune system to respond, preparing it to quickly recognize and defeat the entire virus in the future. It has undergone small phase I and II clinical trials in humans to assess safety and determine what causes an immune response. The vaccine has been approved by the United States Food and Drug Administration for a phase III clinical trial in thousands of people across the country.
In all, the Pittsburgh site seeks to recruit 750 participants over the age of 18 who are not severely immunocompromised. Ideal participants are those who are more likely to be naturally exposed to SARS-CoV-2 due to their public activities or occupations, such as those living in densely populated housing, restaurant and grocery store workers, public transportation drivers, health workers. or nurseries and school teachers. People who belong to communities that have been disproportionately affected by COVID-19, such as black and Latino populations, older adults, and those with certain underlying health conditions, will also receive priority consideration.
Participants will be randomly assigned to receive either the study vaccine or a placebo injection (saline). Neither the participant, their doctor, nor the researchers will know if the participant received the study vaccine or the placebo. They will receive an initial immunization, which can 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 system produces antibodies specific to the virus.
For more information and to subscribe to the trials, visit the COVID-19 Prevention Network website, email [email protected] or call 412-692-7382.
This work is funded by the National Institute of Allergy and Infectious Diseases and the Richard King Mellon Foundation, which last month awarded a $ 250,000 grant to the Pittsburgh Children’s Hospital Foundation to help fund clinical trials for the COVID vaccine. -19.