May 10, 2021 -- Inovio is highlighting results from its phase II clinical trial evaluating its COVID-19 DNA vaccine.
The phase II segment of the company's Inovio INO-4800 Vaccine Trial for Efficacy (INNOVATE) trial, which is still on clinical hold in the U.S., showed that a 2-mg dose of the vaccine, INO-4800, was effective and well tolerated in 400 participants across a range of ages, the company said.
Inovio will file the phase II results with the U.S. Food and Drug Administration (FDA) to address the agency's questions about the Cellectra 2000 device used to deliver INO-4800. Once the FDA has given the go-ahead, Inovio will begin its phase III portion of the trial.
The trial has been funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, according to the firm.
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