Upstate Medical University was selected by the Pfizer and BioNTech partnership to participate in the Phase 3 clinical trial assessing the safety and efficacy of the German company’s BNT162 vaccine targeting the novel coronavirus. Four vaccines in the BNT162 portfolio, the sponsors’ “Project Lightspeed,” tests three of them—BNT162b1, BNT162b2, and BNT162b3—involving 32,000 participants not only in America but also Germany, Brazil, and Argentina. Upstate Medical University is one of 62 research sites around the country participating in this pivotal clinical trial. The U.S. federal government under Operation Warp Speed has procured up to 100 million doses of the experimental vaccine should it be proven in studies to be safe and effective. Now the upstate-based SUNY must find a sufficient number of volunteers.
COVID-19 in Onondaga County, New York
Syracuse is based in Onondaga County, upstate, where a total of 3,464 cases have been recorded along with, according to recent reports, 199 deaths due to COVID-19. With a population of 460,528, Syracuse itself has a relatively diversified population of approximately 163,000. While 56% of the population is White, and just under 30% African American, Hispanic/Latinos represent a growing number of residents, now totaling 8.3 percent.
The Investigational Vaccine
Known as BNT162, the U.S. federal government, as part of Operation Warp Speed, signed up to procure $1.95 billion worth of the product, totaling 100 million doses. President Donald Trump is on the record that OWS will result in a safe and effective vaccine by January 2021. TrialSite has supported the intense mobilization and orchestration of federal resources to combat this horrific pandemic; however, concerns mount about the lack of transparency and what appears like wild deal-making.
Pfizer and BioNTech haven’t accepted development monies, and their optimism for what is a suite of related vaccine products (four of them) grows as they increasingly believe BNT162 is a strong candidate based on assessments of this safety and immune response. Thus far, there haven’t been any serious adverse events reported with the 120 volunteer participants in an earlier study. Advance Media New York’s Syracuse.com reported that only mild to moderate side effects are associated with the investigational product such as fever, fatigue, and chills.
Project Lightspeed Activated
Syracuse New York now joins the “Project Lightspeed” initiative, where SUNY Update Medical University conducts the Phase 3 clinical trial. The site staff just recently administered the first four vaccines, reported Dr. Tim Endy, chair of microbiology and immunology.
This pivotal Phase 3 study is competing against other prominent efforts such as Moderna (mRNA-1273) and the AstraZeneca/Oxford vaccine (AZD1222) and smaller players such as Novavax that received from Operation Warp Speed the not-so-small amount of $1.6 billion and Inovio Pharmaceuticals.
In this Phase 2/3 randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study, the sponsors seek 32,000 healthy adult participants. The team will evaluate the vaccine’s safety, tolerability, immunogenicity, and efficacy of 3 different dose levels. The study will segment three different age groups, including 1) 18-55 years of age, 2) 65-85 years of age, and 3) 18-85 years of age. The study unfolds in three stages including 1) the identification of preferred vaccine candidate(s), dose level(s), number of doses(s), and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a “sentinel” cohort); 2) an expanded-cohort state and 3) an efficacy stage.
Eligible participants must be in good health, between 18 and 85, and the wherewithal to commit to a two-year study. The volunteers will provide blood samples for up to two years once they are administered the vaccine or placebo. Study participants may be seen by the study team up to ten times over the two-year study period.
Individuals who have tested positive for COVID-19 cannot participate in the study.
Upstate Medical University will compensate participants.
The Research Site
Part of SUNY Upstate Medical University, Research spans studies on molecules to model organisms and human populations. The center focuses on diseases that impact the local Upstate community—from diabetes to cancer—to global health challenges such as tropical diseases. Research involves five centers and dozens of departments. SUNY Update Medical University Research offers powerful programs and initiatives such as Pivot (funding for research), CNY Biotech Accelerator (60K sq. foot facility offering labs, resources, etc.), Dimensions (massive repository of research), SUNY Research Foundation access to electronic data capture, and other clinical trial technology from RedCap and more.
Note that SUNY Upstate Medical University announced it has entered Phase 5 of the “restart plan” in a transition to “restart” research during COVID-19. Onsite research activity is approaching normal conditions.
Call to Action: For those interested in participating in this study, call 315-464-9869 or email firstname.lastname@example.org.