![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Inovio Initiates COVID-19 Vaccine Dosing in Phase 2 Study Segment
Inovio Initiates COVID-19 Vaccine Dosing in Phase 2 Study Segment
![Inovio_Logo.png](https://www.fdanews.com/ext/resources/test/Drug-Images4/Inovio_Logo.png?t=1607401365&width=430)
December 8, 2020
Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD).
The phase 2 segment will enroll 400 adult participants at up to 17 U.S. sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., drugmaker plans to complete enrollment by month’s end.
In addition to funding the trial, the DoD awarded the company $71 million to support the manufacture of Inovio’s vaccine-administering smart device, CELLECTRA. However, the phase 3 segment remains on partial clinical hold until the company resolves the FDA’s concerns about the delivery device. Inovio said results from the study’s phase 2 segment should resolve any remaining questions.
Upcoming Events
-
21Oct