Blue Lake and CyanVac Announce Positive Phase 2a Results for Intranasal COVID-19 Vaccine

Blue Lake Biotechnology, Inc., a clinical-stage company specializing in intranasal vaccines, and its affiliate CyanVac LLC have released data from their Phase 2a clinical trial. This study, which involved 227 participants, evaluated the safety, tolerability, immunogenicity, and efficacy of CVXGA, an intranasal vaccine candidate designed to combat COVID-19. This vaccine utilizes the parainfluenza virus 5 (PIV5) vector, aiming to engage the immune system comprehensively to fend off severe infectious diseases.

This trial is notable as it marks the first double-blind, placebo-controlled study of a PIV5-vectored vaccine. The outcomes indicate no significant differences in adverse reactions between those vaccinated with CVXGA and those given a placebo, suggesting that PIV5-vectored intranasal vaccines are generally safe and well-tolerated. Participants who received CVXGA showed S-protein specific serum antibody levels 1.9 times higher than those in the placebo group 29 days post-vaccination. This is a significant finding, especially since it surpasses the antibody response levels reported for other intranasal vaccines in adults.

The vaccine induced S-protein specific serum antibody responses in both younger adults (ages 18-64) and older adults (65 and older). This is crucial since older adults are at a higher risk of severe illness from COVID-19. Remarkably, a single dose of CVXGA resulted in a 78% reduction in the risk of developing symptomatic COVID-19 within the first month after administration compared to the placebo group.

Dr. Biao He, CEO of Blue Lake and CyanVac, highlighted the promising nature of the vaccine’s 78% efficacy, which compares favorably with the 52% efficacy reported for some approved COVID-19 vaccines four weeks post-vaccination. Dr. He also emphasized the well-tolerated nature of the CVXGA intranasal vaccine, contrasting it with the common side effects associated with existing COVID-19 vaccines, such as injection site reactions, fever, fatigue, and headache. The safety and effectiveness data from this trial are promising, and the team looks forward to subsequent clinical studies involving more participants.

The Phase 2a study enrolled 227 participants, who were randomly assigned to receive either the CVXGA vaccine, which targets the S-protein of the omicron XBB.1.5 variant strain of SARS-CoV-2, or a placebo. The primary goals of the trial included evaluating the safety, tolerability, and immunogenicity of the vaccine. Exploratory endpoints looked at the proportion of participants who developed symptomatic SARS-CoV-2 infection.

Dr. He pointed out the ongoing threat of COVID-19 to public health. A vaccine that is more effective, better tolerated, and easier to administer could significantly boost vaccination rates and reduce hospitalizations and deaths caused by COVID-19.

CVXGA is a promising COVID-19 vaccine candidate based on a proprietary PIV5 vector that encodes the spike (S) protein of SARS-CoV-2. Developed at the University of Georgia, the PIV5 vector is derived from a respiratory virus not known to cause disease in humans but commonly used in dog vaccines for distemper and kennel cough. CyanVac and Blue Lake Biotechnology are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and related serious complications. Preclinical studies have indicated that CVXGA is both immunogenic and protective, and it has shown to prevent the transmission of SARS-CoV-2. Phase 1 and Phase 2a clinical trials have demonstrated that CVXGA prompts robust mucosal, cellular, and humoral immune responses with minimal or no reactogenicity and no serious adverse events related to the vaccine.

CyanVac LLC and Blue Lake Biotechnology, Inc. are focused on developing intranasal vaccines that harness the immune system to protect against serious infectious diseases, particularly in vulnerable populations. Their platform utilizes a proprietary PIV5 vector to insert foreign genes from targeted pathogens, creating a pipeline of vaccines aimed at overcoming the limitations of current vaccine technologies. Their leading product candidates have shown the potential for efficacy following a single intranasal dose, with minimal vaccine-related side effects.