A new COVID-19 vaccine candidate is entering Phase 1 clinical human testing today, after the US Food and Drug Administration (FDA) accepted an application from Inovio Pharmaceuticals under the regulator’s Investigational New Drug program.
Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, following promising results from preclinical studies performed on animals that did indicate increased immune response.
The study, funded by the Bill and Melinda Gates Foundation, is a first step to see if the vaccine appears safe enough for larger tests needed to prove whether it will protect. Even if the research goes well, it is expected to take over a year before any vaccine could be widely available.
Last month, the first safety test in people of a different vaccine candidate began in Seattle. It was developed by the National Institutes of Health (NIH) and Moderna Inc.
novio’s approach is what’s called a DNA vaccine, made using a section of the virus’s genetic code packaged inside a piece of synthetic DNA.
The company says it has already begun recruiting volunteers for its study in each of the two locations.
Testing will take place at the University of Pennsylvania’s Perelman School of Medicine and the Center for Pharmaceutical Research in Kansas City.
Each volunteer will get two doses of the experimental vaccine, given four weeks apart.
We anticipate rapid enrollment of this initial study,’ said Dr Pablo Tebas, an infectious disease specialist and professor of Medicine at the Hospital of the University of Pennsylvania who is the principal investigator for that location.
‘There has been tremendous interest in this vaccine among people who want to do what they can to help protect the greater public from this pandemic as soon as possible.’
Inovio anticipates that it will have enough data to do an initial assessment of the vaccine’s safety as well as whether or not it’s triggering an immune response in the participants by this summer.
t’s not the first time that Inovio has worked on a covid-19 vaccine.
The company started developing a vaccine for Middle East Respiratory Syndrome (MERS), the most recent previous, new life-threatening covid-19 to emerge, in 2012.
When the company tested its MERS vaccine, 95 percent of trial participants’ bodies generated high levels of virus-fighting antibodies.
And the vaccine ramped up the broader immune response – measured in search-and-destroy white blood cells, called T cells – for 90 percent of that phase I trial’s participants.
So far, Inovio’s new COVID-19 vaccine seems to work similarly to its MERS formula in lab studies – an encouraging indicator that it might work in human trials.
