Blue Lake Biotechnology and CyanVac reported that a Phase 2a clinical trial of their CVXGA intranasal vaccine against SARS-CoV-2 demonstrated that participants who received CVXGA had a 78% lower risk of symptomatic infection one month post vaccination compared to those who got a placebo. The study enrolled 227 participants. In addition, the companies said that no safety concerns were identified, and CVXGA induced antibodies in adults older than 65 as well as in younger adults.
In 2021, the companies conducted a Phase 1 trial of CVXGA (BLB101), which is based on an attenuated strain of canine parainfluenza virus (PIV5). An upcoming Phase 2b trial in 10,000 participants funded by he Biomedical Advanced Research and Development Authority (BARDA) will be conducted by BARDA’s clinical studies network.
CyanVac and Blue Lake CEO Biao He commented, “The 78% protection compares quite favorably with the efficacy of approved COVID vaccines, which has been reported to be 52% at four weeks after vaccination. Most reassuring are the results showing how well tolerated our intranasal COVID vaccine is, in contrast to currently approved COVID vaccines which are commonly associated with injection site reactions, fever, fatigue, and headache. The safety and efficacy data from this trial are highly encouraging, and we look forward to the dosing of more volunteers in the next clinical study of CVXGA.”
Read the CyanVac and Blue Lake Biotechnology press release.