Cleveland VA joins clinical trials testing experimental COVID-19 vaccines
By JULIE WASHINGTON | Advance Ohio Media | Published: September 2, 2020
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CLEVELAND (Tribune News Service) — Two Ohio research centers — the Louis Stokes Cleveland VA Medical Center and the Ohio State University Wexner Medical Center — are joining the hunt for a safe and effective COVID-19 vaccine.
The Cleveland VA is one of more than 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants in a vaccine trial, the VA announced in a statement. The research will collect data on the safety and immune response of the proposed vaccine BNT162b2.
The proposed COVID-19 vaccine was developed by Pfizer Inc. and the German biotechnology company BioNTech SE.
Cleveland VA trial
The Cleveland VA is the only VA hospital hosting a Pfizer vaccine trial, U.S. secretary of veterans affairs Robert Wilkie wrote in a recent opinion piece.
“The Cleveland VA Medical Center was chosen as the only VA to participate in this study because of proven success incorporating veterans into vaccine trials supported by a strong clinical research program,” said Dr. Curtis Donskey, the Cleveland VA’s chief of infection control. “We feel it’s important to ensure our veteran population is represented in this critical effort. VA provides care for many veterans with chronic conditions that put them at a higher risk for severe outcomes due to COVID-19.”
Donskey and Maragret Tiktin, clinical research center director at the Cleveland VA, will lead the study here.
The VA’s Phase 2/3 study is looking to enroll non-pregnant, healthy adults ages 18-85 who are at risk for contracting COVID-19. Priority will be given to veterans, whether or not they are enrolled in VA care.
An equal number of participants will get the vaccine and placebo during the VA’s trial, the VA said.
Clinical development of new drugs or vaccines is a three-phase process, according to the Centers for Disease Control and Prevention. In Phase 1, small groups of people receive a trial vaccine. In Phase 2, the trial vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and safety.
People interested in participating in the study through the Cleveland VA Medical Center can call 216-791-3800 ext. 65273. Once the maximum number of participants is reached, the VA will track interested participants for a potential future study, the VA Center said.
Wexner Medical Center trial
The Wexner Medical Center will be a test site for a multicenter, 30,000-person clinical trial testing an experimental COVID-19 vaccine, Ohio State announced recently.
The vaccine, called AZD1222, was co-developed by the University of Oxford and the biopharmaceutical company AstraZeneca, Ohio State said in a statement.
A large early-stage clinical trial in the United Kingdom showed this experimental vaccine is safe and prompts a strong immune response, producing both antibodies and T-cells, which find and attack virus cells, the university said.
“Time is of the essence to develop a vaccine and/or drugs that can halt the transmission of (the coronavirus) and reduce the serious health effects and deaths caused by COVID-19,” Dr. Susan Koletar, director of the division of infectious diseases at Ohio State Wexner Medical Center and principal investigator of this vaccine trial, said in a statement.
About 500 adults are needed for the randomized, double-blind and placebo-controlled trial to evaluate how well the AZD1222 vaccine protects people from COVID-19.
The Wexner Medical Center study is looking for participants who are at high-risk for exposure to COVID-19, including people over 65, teachers, first responders, college students, and factory and restaurant workers.
Study participants will receive either the experimental vaccine or a placebo, have blood samples drawn and follow up with medical experts over two years.
Results from the Wexner Medical Center and other clinical trials conducted through the COVID-19 Prevention Network are critical in getting a COVID-19 vaccine to market, said Dr. Rama Mallampalli, chair of the department of internal medicine at The Ohio State University College of Medicine, in a statement.
The National Institute of Allergy and Infectious Diseases created the COVID-19 Prevention Network, using the infectious diseases expertise at four of its existing clinical trials networks. This allowed the network to quickly set up COVID-19 clinical trials at sites with a long history of research and collaboration, Mallampalli said.
The new study will enroll adults 18 to 85 who are not pregnant. Because of the disproportional rate of COVID-19 among people of color, UH plans to ensure that people of color are well represented in this study, the hospital system said. Call 612-524-9091 to learn how to participate.