Penn Medicine is a participant in the Phase I safety and immunogenicity clinical trial of INO-4800, a DNA vaccine designed to prevent COVID-19 infection.
Approved by the U.S. Food and Drug Administration (FDA) on April 6, Phase I clinical testing of the vaccine started immediately, with first dosing planned to begin in up to 40 healthy volunteers the same day.
A second site, the Center for Pharmaceutical Research in Kansas City, MO, will also participate in the trial.
How Does the INO-4800 COVID-19 Vaccine Work?
According to vaccine developer Inovio (Plymouth Meeting, PA), INO-4800 is a DNA vaccine candidate matched to the novel coronavirus SARS-CoV-2, the cause of COVID-19 disease in humans. DNA vaccines are composed of optimized DNA plasmids, small units of double-stranded DNA synthesized or reorganized by computer sequencing technology designed to produce a specific immune response in the body.
INO-4800 is administered with a proprietary device, CELLECTRA 3PSP, designed by INOVIO to deliver optimized DNA into cells in the hope that these cells will be translated into proteins that generate a robust targeted T cell and antibody response to SARS-CoV-2. The hand-held, portable device runs on AA batteries and intradermally delivers the vaccine.
INO-4800 Phase I: COVID-19 Vaccine Study Design
Each participant in the Phase I trial will receive two doses of INO-4800 four weeks apart. The initial immune responses and safety data from the study are expected by late summer.
Preclinical data, which have been shared with global regulatory authorities and were submitted as part of the FDA submission, showed promising immune response results across multiple animal models.
In late June, interim data from INO-4800 suggested that 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 after two doses of INO-4800 in trial with 40 healthy volunteers in preliminary analyses.
Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial. Upon attaining initial safety and immunogenicity data from Phase 1 studies, Inovio plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as possible.
Perelman School of Medicine is an INO-4800 Test Site
Pablo Tebas, MD, Director, Developmental Core, Penn Center for AIDS Research, and Director, Principal Investigator, AIDS Clinical Trial Unit (ACTU) research site, will lead the trial as principal investigator at the Perelman School of Medicine.
"We anticipate rapid enrollment of this initial study," Dr. Tebas said in a recent interview. “There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible."
The global coalition of collaborators and partners assembled by Inovio includes the scientific team at the Wistar Institute of the University of Pennsylvania, whose contributions included key research. Inovio Pharmaceuticals received a $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing of the CELLECTRA 3PSP device to deliver the vaccine.