Coronavirus Vaccine Candidate Found 94% Effective
5 min readJune 30, 2020INOVIO INO-4800 vaccine joins Operation Warp Speedhttps://www.precisionvaccinations.com/coronavirus-vaccine-candidate-found-94-effectiveA Pennsylvania based biotechnology company announced positive interim clinical data of INO-4800, its vaccine candidate against the SARS-CoV-2 virus, from the first two Phase 1 clinical trial cohorts.
INOVIO stated 94 percent of Phase 1 trial participants demonstrated overall immune responses at Week #6, after 2-doses of INO-4800, in a preliminary analysis.
In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed.
Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.
Dr. J. Joseph Kim, President and CEO of INOVIO, said in a press statement, "We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."
The Phase 1 clinical trial of INO-4800 initially enrolled 40 healthy adult volunteers 18 to 50 years of age at two U.S. sites. The participants were enrolled in 1.0 mg and 2.0 mg dose cohorts; each participant received two doses of INO-4800 four weeks apart.
Each dose was administered by intradermal injection using INOVIO's CELLECTRA® 2000 device.
An independent Data Safety Monitoring Board reviewed the safety data.
INO-4800 was generally safe and well-tolerated in all participants in both cohorts through week 8; all ten reported adverse events were grade 1 in severity, and most were local injection site redness.
And, there were no reported serious adverse events.
Multiple immunology assays including those for humoral and cellular immune responses are being conducted for both 1.0 mg and 2.0 mg dose cohorts after two doses at week #6.
Analyses to date have shown that 34 out of 36 total trial participants (94%) demonstrated overall immunological response rates based on preliminary data assessing humoral (binding and neutralizing) and T cell immune responses.
