Inovio doses first volunteer as part of Covid-19 vaccine mid-stage trial
Inovio doses first volunteer as part of its COVID-19 vaccine mid-stage trial
(Reuters) – Inovio Pharmaceuticals Inc said on Monday it has dosed the first participant in a mid-stage clinical trial testing its COVID-19 vaccine candidate, INO-4800.
The Phase 2 portion of the Phase 2/3 study will enroll about 400 participants who are 18 years or older, to assess the vaccine’s ability to produce immune response and to determine the appropriate doses for a later study, the company said.
Inovio said it plans to fully enroll the Phase 2 segment of the trial, which is being funded by the U.S. Department of Defense, by the end of this month.
The U.S. Food and Drug Administration in September put Phase 3 of the mid-to-late stage trial on hold, as it sought more information, including details on a delivery device called Cellectra used to inject INO-4800 into skin cells.
FILE PHOTO: The word “COVID-19” is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration
That portion of the trial remains on hold until Inovio resolves the agency’s questions, the company said.
Inovio said it plans to address the remaining device-related questions during the Phase 2 part and prior to the start of the Phase 3 segment of the trial.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta
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