Yesterday, Inovio Pharmaceuticals, Inc. announced that it will begin human trials on a potential vaccine for COVID-19. The US Food and Drug Administration accepted its investigational drug application for the candidate vaccine, now called INO-4800, and the company will start injecting healthy volunteers in a Phase I trial as soon as this week.
Preclinical data obtained using various animal models have shown that the vaccine can initiate an immune response. Now, the company has to demonstrate that it triggers an immune response in people as well and that it is safe.
The Phase 1 trial will be enrolling around 40 healthy participants at one of two sites: the Perelman School of Medicine at the University of Pennsylvania in Philadelphia or the Center for Pharmaceutical Research in Kansas City, Missouri. Every volunteer is slated to receive two doses of the vaccine, one four weeks after the other. The company expects the results from the trial in late summer.
"We anticipate rapid enrollment of this initial study," said the Principal Investigator of the study Pablo Tebas, MD, an infectious disease specialist and professor of Medicine at the Hospital of the University of Pennsylvania. "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."
Their vaccine uses a small piece of DNA that is injected into the body (and is supposed to initiate an immune response). Like other vaccines, priming the immune system in this way gives the body a 'memory' of an infection so that if it does encounter the pathogen, it already has antibodies in place to fight it. DNA vaccines are used in veterinary medicine but have not yet been used in humans.
Inovio is supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation. Bill Gates has said in a recent interview that his foundation is planning to pick seven top COVID-19 vaccine candidates and generate the infrastructure to manufacture all of them. Not every one will be a winner, he said two at most might make it to market, but this will rapidly accelerate the process by building a factory as the vaccine is being developed, instead of waiting until it's already been created to start construction.
If the trials produce good results, Inovio claims it can have up to one million vaccine doses ready for around the end of the year, which could be used in more trials or as emergencies required. It would take a few more months to have the vaccine ready for a wider rollout.
"This is a significant step forward in the global fight against COVID-19," said the President and CEO of Inovio, Dr. J. Joseph Kim. "Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing. Our dedicated team of staff, partners and funders have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials."
Inovio also already has a little experience in this field. The company has previously completed a successful clinical trial that tested a vaccine for the coronavirus that causes MERS.