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Covid-19 Nasal Spray Vaccine Trial Underway

Baio He

Baio He and friend in 2017 (Nancy Evelyn, University of Georgia)

27 Sept. 2021. A clinical trial testing the safety of a Covid-19 vaccine from an engineered virus found in dogs and given as a nasal spray enrolled its first participant. The vaccine is made by CyanVac LLC and its subsidiary Blue Lake Biotechnology Inc. in Athens, Georgia, a spin-off company from University of Georgia, also in Athens.

CyanVac and Blue Lake Bio develop vaccines for infectious diseases based on research by their founder Biao He, professor of veterinary medicine at UGa, and the companies’ CEO. He and colleagues study the canine parainfluenza virus 5, or PIV5, which as the name implies, occurs in dogs. Research by He shows engineered forms of PIV5 are safe for humans and animals, and can be genetically altered to carry weakened forms of infectious viruses to generate immune responses by recipients. Teams led by He last year demonstrated engineered PIV5 viruses could protect lab mice against infections from Middle East Respiratory Syndrome or MERS, a coronavirus responsible for a regional pandemic, and earlier against H5N1 avian influenza, a dangerous flu strain.

One finding from their studies is the stability of vaccines made with PIV5, which allows for delivery in forms other than the typical syringe injection, such as a nasal spray. CyanVac’s lead product, code-named, CVXGA1, is one such vaccine expressing the SARS-CoV-2 spike protein that enters cells and begins the infection process. The company says in preclinical tests with animals, a single dose of the nasal spray in each nostril produces protective responses both from antibodies and immune-system cells.

Recruiting 80 participants at three sites

CyanVac is initially developing CVXGA1 as a booster for existing Covid-19 vaccines, but eventually to serve as a primary vaccine where current vaccines are in short supply. “Our aim is to have a single-dose intranasal vaccine,” says He in a company statement released through Cision, “that can be used as a booster for existing vaccines, as well as a vaccine that can serve as a primary vaccine to countries that are struggling to acquire enough vaccine doses for their populations.”

CyanVac says the early-stage clinical trial enrolled and dosed its first participant in Rochester, New York. Other sites are in Cincinnati, Ohio and Bardstown, Kentucky. The trial is enrolling 80 healthy adult participants, randomly assigned to receive either a low or high dose of CVXGA1, with participants further divided by age groups: 18 to 55 and 56 or older. The study team led by Paul Spearman of Cincinnati Children’s Hospital Medical Center, is looking primarily for any adverse effects of the vaccine up to 28 days following administration. In addition, researchers are measuring immune responses to the vaccine, particularly immunoglobulin G antibody concentrations in blood serum.

“CyanVac’s investigational vaccine has the potential to be both a needle-free vaccine and one that could block disease transmission,” notes Spearman. “For some individuals this may help overcome vaccine hesitancy, and even more importantly it could halt the virus at its point of entry and prevent further spread of Covid-19.”

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