As an early stage trial, the study is only looking for data on the safety of INO-4800 and its immunogenicity, that is, its ability to trigger the desired immune response in the body. (Note that three of the trial participants were positive for COVID-19 at the start of the study, indicating that they had contracted the virus before being enrolled in the study, and one left the trial for non-clinical reasons.)
Intermediate data from the trial revealed no serious safety concerns associated with the vaccine – it was “generally safe and well tolerated”. However, the participants experienced redness on the skin where the vaccine was administered. Importantly, 94% of them demonstrated an immune response six weeks after receiving the vaccine. Specifically, Inovio said that its potential vaccine had “the ability to generate balanced immune responses in antibodies and T cells.” (T cells are white blood cells that bind to and kill infected cells.) Biotechnology plans to start a phase 2/3 clinical trial for INO-4800 later this summer, pending regulatory approval.
Inovio also announced that INO-4800 has been selected for a study under the auspices of the US Government’s Operation Warp Speed, an initiative dedicated to supporting the rapid development of SARS-CoV-2 vaccines. INO-4800, along with other candidate vaccines, will be tested in a challenge study in non-human primates in which inoculated animals are deliberately exposed to the coronavirus.
It should also be noted that Inovio recently won a $ 71 million contract from the Department of Defense, some of which will be used to increase the manufacturing of its Cellectra 3PSP smart devices, and the rest to purchase a large quantity of Cellectra devices. 2000 of Inovio. These two portable injection systems are used to deliver DNA vaccines like INO-4800 more effectively, using electrical pulses to allow vaccines to enter cells of the recipient’s skin directly.