Cincinnati Children's is among four U.S. sites participating in a global clinical trial for a possible COVID-19 vaccine.
The hospital is looking for up to 90 participants ages 18-55 and 65-85 for the first phase of the study. The candidate vaccines - four variations of one vaccine - are being jointly created by BioNTech SE and Pfizer Inc.
"We're using the vaccine to induce our body to make part of the outside of the virus called the spike protein. That spike protein is what looks like is very important for the virus to be able to cause an infection in us," says Robert Frenck, MD, professor of pediatrics in the Division of Infectious Diseases at Cincinnati Children's Hospital and the UC College of Medicine.
The hope is the antibodies created by our immune system's response to the spike protein will protect us from the disease should we be exposed.
Frenck is also director of the Vaccine and Treatment Evaluation Unit (VTEU) and Gamble Program for Clinical Studies. The VTEU is one of nine National Institutes of Health-funded programs that tests vaccines for things like Ebola and the flu.
Participants won't be given the whole virus, so Frenck says people shouldn't be concerned about getting the disease from the vaccine. Healthy adults in the younger of the two age cohorts will get the vaccine first to determine the safety, immunogenicity and optimal dosing level.
Frenck says the goal is to have the first of three phases completed by June; Phase 2 by the end of summer or early fall; and then begin enrolling thousands of participants nationwide for wide-scale testing (Phase Three).
"If everything was perfect, I would say (it could be) a year from the time that we start to the time that we'd have some data about the Phase Three study, probably closer to 15 to 18 months, but at least we get some inkling, I think, by this time next year."
The study began in Germany where the first participants received doses last week. Other U.S. sites include NYU Grossman School of Medicine, the University of Maryland School of Medicine, and the University of Rochester Medical Center/Rochester Regional Health.
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