Blue Lake Biotechnology and CyanVac LLC have announced positive results from their Phase 2a clinical trial of CVXGA, an intranasal vaccine candidate for COVID-19. The study, involving 227 participants, demonstrated the vaccine's safety, tolerability, immunogenicity, and efficacy.
The double-blind, placebo-controlled trial, the first of a PIV5-vectored vaccine, revealed no significant difference in adverse reactions between the CVXGA and placebo groups, indicating good tolerability. Vaccinated participants showed a 1.9-fold increase in S-protein specific serum antibody titers 29 days post-vaccination compared to the placebo group. Notably, CVXGA elicited robust antibody responses in both younger (18-64 years, p=0.002) and older adults (65 years and older, p=0.032).
Efficacy and Safety Profile
Participants receiving a single dose of CVXGA experienced a 78% lower risk of developing symptomatic COVID-19 infection within the first month after vaccination, compared to the placebo group. Biao He, Ph.D., CEO of Blue Lake and CyanVac, noted that "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."
Dr. He also emphasized the vaccine's tolerability, stating, "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."
About the CVXGA Vaccine
CVXGA is based on a parainfluenza virus 5 (PIV5) vector encoding the spike (S) protein of SARS-CoV-2. Blue Lake Biotechnology and CyanVac are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and its complications. Preclinical studies have shown that CVXGA is immunogenic, protective, and prevents SARS-CoV-2 transmission. Prior Phase 1 studies also demonstrated robust mucosal, cellular, and humoral immune responses with minimal reactogenicity.
Future Directions
With COVID-19 remaining a public health concern, the development of more effective, better-tolerated, and easily administered vaccines is crucial. Blue Lake and CyanVac are preparing for the next clinical study of CVXGA, building on these promising Phase 2a results.
