Biotechnology company INOVIO revealed that the placebo-controlled and blinded phase two segment of a United States clinical vaccine trial has shown positive, safe, and well-tolerated results for INO-4800 when used against COVID-19.
As a result of the test results, a 2 mg dose will be used for the phase three segment of the trial, although due to the U.S. Department of Defense cutting funding for that segment last month, this testing will likely be conducted outside the U.S. Results of this latest trial — INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) — have been published as a preprint in MexRxiv.
“We thank the volunteers who are participating in our INNOVATE Phase 2 blinded trial, as well as the research partners, clinical teams, and INOVIO employees who have been working tirelessly to advance this important work,” Dr. Laurent Humeau, INOVIO’s Chief Scientific Officer, said. “Our Phase 2 results validate our initial COVID-19 Phase 1 results in a larger population, which show that INO-4800 continues to be generally safe, well-tolerated, and immunogenic in all studied age groups. The expanded data set enabled a clear dose selection to be made with 2.0 mg as the dose for the global Phase 3 efficacy trial.”
INO-4800 is a DNA vaccine. In the phase two trial, approximately 400 people participated across 16 sites, where they were given either the vaccine or a placebo in two doses, four weeks apart. Those vaccinated gained immunity-boosting antibody titers, and the vaccine itself was generally well-tolerated, with the majority of adverse events not appearing to increase in severity from one dose to the next. Both 2 mg and 1 mg doses were tested, but the 2 mg dose fared much better. Preliminary results will be filed with the Food and Drug Administration.
This phase two trial was funded by the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency.