CyanVac LLC has commenced a Phase 2b clinical trial for its intranasal COVID-19 vaccine candidate, CVXGA, with the first participant dosed. This study, backed by the U.S. Government’s Project NextGen, aims to evaluate CVXGA against an FDA-approved injectable mRNA-based COVID-19 vaccine, both targeting the Omicron variant KP.2 strain of SARS-CoV-2. The trial is designed to assess the relative efficacy of CVXGA in preventing symptomatic COVID-19, as well as its potential to prevent asymptomatic infections, which could indicate its ability to curb virus transmission.
Trial Design and Enrollment
The Phase 2b study will initially enroll approximately 400 participants in sentinel and safety lead-in cohorts. Following a review of the safety data by an independent Data and Safety Monitoring Board (DSMB) and approval from the Biomedical Advanced Research and Development Authority (BARDA), the trial will expand to include approximately 9,600 additional participants. The study aims to enroll a diverse group of approximately 10,000 adults representative of the U.S. population, including those at high risk for severe COVID-19. Participants will be monitored for SARS-CoV-2 infection for 12 months post-vaccination.
CVXGA: An Intranasal Vaccine Approach
CVXGA utilizes a proprietary parainfluenza virus 5 (PIV5) vector to deliver the spike (S) protein of SARS-CoV-2. The PIV5 vector, developed at the University of Georgia, is based on a respiratory virus not known to cause disease in humans and has been used in canine vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and its associated complications. Preclinical studies have indicated that CVXGA is immunogenic, protective, and can prevent SARS-CoV-2 transmission. Prior Phase 1 and Phase 2a clinical studies demonstrated robust mucosal, cellular, and humoral immune responses with limited reactogenicity and no serious vaccine-related adverse events.
Executive Perspective
"This phase 2b trial represents a major milestone for our proprietary PIV5-based vaccine platform," stated Biao He, Ph.D., founder and CEO of CyanVac. "We expect this new Phase 2b trial to play a key role in confirming these results and validating the potential of our PIV5-based vaccine platform."
Funding and Collaboration
This project is funded by federal funds from HHS, ASPR, and BARDA under Other Transaction (OT) number 75A50123D00005. The Phase 2b study is being conducted through BARDA’s Clinical Studies Network.
