Cincinnati Children’s Testing Candidate Vaccine to Prevent COVID-19 infection
Local Medical Center One of Four U.S. Testing Sites
Tuesday, May 05, 2020
Cincinnati Children’s is one of four sites in the U.S. participating in a Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial, part of a global development, began in Germany where the dosing of the first participants was completed last week.
The other three testing sites in the U.S. include the NYU Grossman School of Medicine, the University of Maryland School of Medicine, and the University of Rochester Medical Center/Rochester Regional Health.
The candidate vaccines to prevent COVID-19 infection are from a joint development program by BioNTech SE and Pfizer Inc.
The study arm at Cincinnati Children’s is led by Robert Frenck, MD, Director of the NIH-funded Vaccine and Treatment Evaluation Unit (VTEU) and Vaccine Research Center. The program is a national leader in vaccine research and one of nine NIH VTEUs in the U.S. The program is testing vaccines for several global health challenges like Ebola, influenza and now COVID-19.
Despite international efforts to develop vaccines and drugs to stem the tide of COVID-19, the most important step people can take to protect themselves is to avoid infection, Frenck said.
“COVID-19 is a virus to which people have not been previously exposed, so everyone is susceptible to getting the infection,” Frenck said. “While social distancing is effective, it is difficult to maintain long term. We are excited about this vaccine and think it has the possibility to decrease the risk of infection from COVID-19.”
Cincinnati Children’s will enroll up to 90 participants in the first stage of the study. Participant recruitment and screening are now underway with initial administrations of candidate vaccine in Cincinnati expected to begin in the next two weeks.
The study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study, according to BioNTech and Pfizer. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age).
The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.
The prospective vaccine works by having our body make a piece of the virus called the spike protein, Frenck said. The body then makes antibodies to the spike protein designed to protect people against COVID-19 should they be exposed to the virus.
Frenck emphasized that study participants will not be given the whole virus, making it impossible to get COVID-19 from the vaccine.
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