The phase 2 segment has been designed to assess the safety and immunogenicity of INO-4800 Covid-19 vaccine candidate to confirm the dose for the subsequent efficacy assessment as part of the phase 3 segment of the trial.
INO-4800 is claimed to be the only nucleic-acid based vaccine, which is stable at room temperature for over a year and does not require to be frozen during transport or storage.
In November, Inovio secured approval from the US Food & Drug Administration (FDA) to begin phase 2 segment of its planned phase 2/3 clinical trial for its Covid-19 DNA vaccine candidate.
With a plan to complete enrolment by the end of this month, the phase 2 segment will recruit around 400 participants who are 18 years or older at up to 17 US sites.
INNOVATE is a randomised, blinded and placebo-controlled safety and efficacy study, which is funded by the US Department of Defense (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 (DHA).
The phase 2 segment will assess safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen, including 1.0mg or 2.0mg.
The patients will secure either INO-4800 or placebo in a three-to-one randomisation to confirm the more appropriate dosing level for each of three age groups, including 18-50 years, 51-64 years and 65 years and older, at high risk of SARS-CoV-2 exposure for the subsequent phase 3 efficacy assessment.
The DoD will offer funding for both the phase 2 and Phase 3 segments of INNOVATE, in addition to the $71m of funding earlier announced in June for the large-scale manufacture of the firm’s next-generation smart device Cellectra 3PSP and the procurement of Cellectra 2000 devices.
Inovio president and CEO Dr Joseph Kim said: “We’re pleased to move into the Phase 2 segment of our 2/3 trial on the pathway to establish our DNA technology as an integral component of the pandemic response given its potential for an outstanding safety profile and its demonstrable thermostability.”