Representing one of four sites across the United States, principal investigator and former Naval Officer Dr. Robert Frenck at Cincinnati Children’s Hospital is leading the Phase I/2 trials investigating the BNT 162 COVID-19 vaccine. Developed by a German biotech venture called BioNTech (Nasdaq: BNTX), Pfizer teamed up and is now a co-sponsor in a critically important endeavor involving a novel mRNA-based COVID-19 vaccine also known as “Project Lightspeed.” Dr. Frenck directs the NIH-funded Vaccine and Treatment Evaluation Unit and Vaccine Research Center at Cincinnati Children’s. The research center excels at engaging with underserved populations to ensure equitable representation of participants in critical research.
The Phase 1 and 2 randomized, placebo-controlled, observer-blind, dose-finding and vaccine candidate-selection study in healthy adults evaluates the safety, tolerability, immunogenicity and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19:
· As a 2-dose or single-dose schedule
· At up to 3 different dose levels
· In 3 age groups (18 to 55 years of age, 65 to 85 years of age, and 18 to 85 years of age.
This study consists of 3 stages, including 1) identify preferred vaccine candidate(s), dose level (s), number of doses 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 stage; and 3) a final candidate/dose large-scale stage. By the time this stage 3 occurred, up to 7,600 participants would have received the vaccine. The primary completion date for this study is next year (April 2021).
Other research sites participating in this study include the University of Maryland, Center for Vaccine Development and Global Health, NYU Langone Health and Rochester Regional Health/Rochester General Hospital in New York.
Status in Cincinnati
Cincinnati Children’s Hospital has initiated the study and the first set of patients were recently vaccinated as part of the study, reported Local 12 news. Cincinnati Children’s Hospital is only one of four research sites selected across the United States for this critically important study. Part of the effort here involves the recruitment of a diverse and representative sampling of the population. Cincinnati Children’s Hospital has a commitment to diversity exhibited in the many programs including its Administration Fellowship Program, Culture of Comprency Champions Program, Employee Resources Groups, Mentor Program and more. Access to the study is available here.
Cincinnati is a diverse place with a sizeable African American population. With about 306,000 inhabitants, the town is approaching 45% black population. Blacks have died at higher rates than others and hence it is imperative to ensure diverse participation in vaccine studies, including African Americans.
About BNT 162
The intellectual property forming the basis for four vaccine candidates is known as project “Lightspeed”—each vaccine candidate represents different mRNA formats and target antigens. Two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other candidates. The RBD-based candidates containing the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.
Dr. Robert French, MD, serves currently as Medical Director, Division of Infectious Diseases as well as Director, Vaccine Research Center and a Professor at UC Department of Pediatrics. His research interests range from therapeutic and vaccine clinical trials with a special interest in enteric diseases to pediatrics. Dr. Frenck served his country for 25 years in the Navy.
Call to Action: For those living in or near Cincinnati, consider reviewing the eligibility criteria and participating in the vaccine trial.