The trial will evaluate the effectiveness and safety of a new vaccine compared to an FDA-approved mRNA vaccine.
University of Georgia-based startup CyanVac LLC has received federal funding to conduct a Phase 2b clinical trial to compare its intranasal vaccine candidates, CVXGA, which are designed to provide protection against COVID-19.
As part of the award from Project NextGen, a federal initiative based in the U.S. Department of Health and Human Services (HHS), CyanVac will sponsor a randomized, double-blind Phase 2b study with 10,000 participants to compare the efficacy and safety of the intranasal vaccine against an FDA-approved mRNA-based COVID-19 vaccine.
The new vaccine is based on a viral delivery platform developed by He containing modified strains of parainfluenza virus 5, which causes kennel cough in dogs but is relatively harmless to humans.
Parainfluenza virus 5 (PIV5) is a member of the Paramyxoviridae family known to infect dogs, leading to respiratory illnesses similar to kennel cough. It can also infect other mammals, including humans, typically causing mild respiratory symptoms. The virus is airborne and spreads through respiratory droplets, necessitating good hygiene and isolation practices to control outbreaks.
CyanVac's Commitment and Project Goals
CyanVac was founded by Biao He, Regents' Entrepreneur, Fred C. Davison Distinguished University Chair in Veterinary Medicine and a faculty member in UGA's College of Veterinary Medicine (CVM). He served on a White House panel to advise on the future of COVID-19 vaccines and was named both UGA Inventor and Entrepreneur of the Year.
Biao He in his laboratory. Credit: Andrew Davis Tuckert
"We are very excited about this opportunity to test a novel intranasal COVID vaccine whose technology platform has been developed at UGA," said He, who is based in UGA's Department of Infectious Diseases. "The name of our vaccine—CVXGA—is a tribute to UGA and CVM whose support over the years made this possible."
Project NextGen's goal is to advance new, innovative vaccines and therapeutics that provide longer-lasting and more durable protection against COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the HHS Biomedical Advanced Research and Development Authority (BARDA) to accelerate product and technology development.
The Phase 2b study, which will begin this fall, will be carried out by BARDA's Clinical Studies Network, focusing on evaluating the vaccine in a subset of participants who are at a higher risk of severe disease.
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