One attraction of the delivery system is that it could halt the virus at the point of entry to the body, when it is inhaled. It could also be used to administer vaccines to broad populations: including children or those who are needle-hesitant.
The vaccine, CVXGA1, is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the S protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, and has been used in dog vaccines for decades.
In preclinical studies the COVID-19 vaccine, delivered intranasally as a single dose in each nostril, induced mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and was been effective in protecting multiple animal species from SARS-CoV-2 viral infection and in blocking SARS-CoV-2 viral transmission, according to the company.
The Phase 1 trial is a multi-center, open-label trial to evaluate the safety, reactogenicity and immunogenicity of CVXGA1 administered intranasally as a single dose. It will cover two age cohorts. The first will consist of 40 participants aged 18 - 55 who will receive a single dose of vaccine by intranasal spray, escalating from low dose (106 PFU) to high dose (107 PFU). A second cohort of 40 participants, aged 56 – 75, will receive a single dose of vaccine, escalating from low dose to high dose.
Safety data will be collected and analyzed, as will serum and mucosal antibody responses, and cellular immune responses to the SARS-CoV-2 S protein.
"The enrollment of the first participant in our first-in-human Phase 1 clinical trial marks another important milestone in our rapid growth as a vaccine company," said Dr. Biao He, founder and President of CyanVac and Blue Lake Biotechnology. "Our aim is to have a single-dose intranasal vaccine 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."
The COVID-19 vaccine is now the US company’s most advanced candidate in its pipeline: while its proprietary tech is also being used in candidates against RSV, norovirus and Lyme Disease.