Phase One Clinical Trial is Underway for the COVID-19 Nasal Vaccine Produced by St. Louis Startup

    By Kathleen Berger, Executive Producer for Science & Technology

    At Mercy Hospital St. Louis, Gary Zigrang is among the first in St. Louis to receive the first generation COVID-19 vaccination. Zigrang has a heart condition, diabetes and an aneurysm making him high-risk for severe illness, even death from COVID-19.

    “It’s been so long thinking you could catch the virus and die,” said Zigrang. “Now that the vaccine’s out, it’s such a relief!”

     More vaccines are coming. Over time, not all will be the same type. Experts say the next generation of vaccines could be even better. This may include a nasal spray, not an injection. It would be delivered in one dose through the nose.

    “You lean your head back and take a spray, so it’s quite easy,” explained David T. Curiel, MD, PhD, professor of radiation oncology for Washington University School of Medicine in St. Louis. Curiel and his team believe the intranasal vaccine they developed in St. Louis produces a superior immune response compared to current vaccines that have been authorized and recommended for use.

    The intranasal vaccine is now produced by academic spinoff Precision Virologics with Curiel as the interim CEO. The vaccine fist proved successful in animal studies and now a human clinical trial for the vaccine is underway. Precision Virologics partnered with vaccine manufacturer Bharat Biotech in India where the trial is taking place.

    “Bharat Biotech licensed our agent. They manufactured it with our help. They got through regulatory in India and they started phase one intranasal vaccine trial,” said Curiel. “So if all goes according to plan, in March we’ll have human data with our vaccine.”

    To develop the vaccine, Curiel’s team took the SARS-CoV-2 spike protein that the virus uses to invade cells and inserted it inside another virus, called an adenovirus.

    “The adenovirus is a common cold virus,” explained Curiel. “I’ve worked on adenovirus for 30 years. I’m the most published, the most cited author in this virus.  I’m the biggest fan of this virus and I knew its attributes.”

    Curiel said the nasal vaccine is working because Precision Virologics is using a version of the adenovirus that infects chimpanzees as many people have immunity to the human adenovirus.

    “The major advantage of using a nonhuman adenovirus is that it could penetrate preformed immunity,” said Curiel.

    The vaccine is proven safe and effective in animal studies, and the vaccine does not require ultra cold storage.

    “The side effects of adenovirus vaccines do appear to be less than mRNA, which have been soreness, fatigue, fever symptoms. Those symptoms are thought to be linked to the storage agent for the mRNA,” Curiel explained.

    Curiel said the nasal delivery route creates a more widespread immune response than an injection. It would destroy any coronavirus already present and prevent the spread the virus to others. The research at Washington University School of Medicine in St. Louis showed how mice given a single dose of the intranasal vaccine were fully protected from SARS-CoV-2.

    “It sterilized the upper respiratory tract so it appeared to have a better ability to provide immunity at the sites relevant to infection”, said Curiel. “This finding may be important to preventing the spread of the virus. And that is what’s so important in a pandemic agent like this.”

    If the clinical trial goes as well as expected in India, Curiel expects a clinical trial in the United States this year with trial locations in St. Louis.