“Project Lightspeed” is coming to University Hospitals Cleveland Medical Center (UH) to conduct the pivotal Phase 2/3 global clinical trial sponsored by Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX, “BioNTech”) testing the investigational vaccine called BNT162b2, against SARS-CoV-2. UH’s study site is one of approximately 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants. Identified as one of the most advanced vaccine candidates in the BNT162 program, it is currently under investigation in the United States and Germany and recently received Fast Track designation from the U.S. Food and Drug Administration (FDA). Study teams are seeking diverse participation as the COVID-19 pandemic impacted at-risk groups harder, such as African Americans, Hispanics and those individuals working in sectors increasing the probability of exposure to the virus.
A Prominent Study Site
Daniel I Simon, MD, Chief Clinical & Scientific Officer and President UH Cleveland Medical Center, recently commented for a UH press release, “This is encouraging news for Ohioans.” “We were among the first in the nation to test Remdesivir, the promising drug in the treatment of COVID-19, which enabled our community to benefit from our participation in the clinical trial program. And now once again, we are bringing our community another potential defense mechanism in our fight against the coronavirus – a vaccine candidate. The trial has been approved by the FDA and our Institutional Review Board. We are expecting shipment of the experimental vaccine and initiation of the trial in the next week.”
Principal Investigator POV
The study will be led at UH by Principal Investigator Robert Salata, MD, Chairman of the Department of Medicine, UH Cleveland Medical Center, Program Director of the UH Roe Green Center for Travel Medicine & Global Health, as well as Professor of Medicine, Epidemiology and International Health at Case Western University. Dr. Salata is joined by co-investigators Elie Saade, MD, UH Director of Infection Control and Scott Fulton, MD and George Yendewa, MD, Assistant Professors of Medicine at UH Cleveland Medical Center
Dr. Salata commented, “The need for an effective vaccine is critical in the fight against the COVID-19 pandemic.” He continued, “There is presently no cure for the highly contagious novel coronavirus that causes COVID-19 and our best plan of attack is to find a vaccine that can help protect people from getting it in the first place. The trials we are preparing to conduct are especially significant because if proven safe and effective, and the vaccine receives regulatory approval, Pfizer and BioNTech expect to be able to manufacture up to 100 million doses by the end of 2020.”
The Study & Need for Diverse Participation
The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review for this unique vaccine development approach, which uses mRNA packaged with coronavirus genes to generate the spike protein which is believed to generate protective antibodies. The study aims to enroll non-pregnant adults from 18 to 85 years.
Because of the disproportionate occurrence of COVID-19 among people of color, as well as the severity of the disease and the higher death rate, UH plans to ensure solid representation of this population group is included in its study.
The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.
Clinical Trials at UH
UH conducts hundreds of clinical trials at any one time. They maintain a Clinical Research department that supports the various studies across therapeutic departments with the center. For patients interested in learning more, they offer “Patient Education” as well as “Patient Stories” and Resources.
UH offers a central clearinghouse for study support, including IRB support, electronic data capture services (RedCap), TriNetX participation (aggregation of patient data for participation in a network) and more.
Robert Salata, MD, Chairman of the Department of Medicine, UH Cleveland Medical Center, Program Director of the UH Roe Green Center for Travel Medicine & Global Health
Elie Saade, MD, UH Director of Infection Control
George Yendewa, MD, Assistant Professors of Medicine at UH Cleveland Medical Center
Call to Action: If you reside in the Cleveland area, consider participation. Those interested in participating in the study at UH should call 612-524-9091 to learn more.