Blue Lake Biotechnology’s Intranasal COVID-19 Vaccine Candidate Demonstrates Long-Lasting Immunity and Broad Protection
Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company specializing in intranasal vaccine development, along with its affiliate CyanVac LLC, recently published two pivotal preclinical studies in the Journal of Virology. These studies highlight the durability and broad protective efficacy of CVXGA, an intranasal COVID-19 vaccine candidate based on a parainfluenza virus 5 (PIV5) vector. The results reinforce the potential of this innovative vaccine to address ongoing challenges in COVID-19 prevention, including waning immunity and the emergence of new viral variants.
A Novel Approach to COVID-19 Vaccination
Unlike traditional injectable COVID-19 vaccines, CVXGA is designed to be administered intranasally, targeting the mucosal immune system—the first line of defense against respiratory pathogens. Blue Lake Biotechnology’s platform leverages PIV5 as a viral vector, which has been shown to stimulate a robust immune response by engaging multiple arms of the immune system, including mucosal, humoral, and cellular immunity.
Dr. Biao He, Ph.D., founder and CEO of both Blue Lake and CyanVac, emphasized the significance of these findings:
“These studies provide compelling evidence that intranasal vaccination with CVXGA not only induces long-lasting immune responses but also serves as a highly effective booster against emerging variants,” Dr. He stated. “With the continued threat of SARS-CoV-2 and as new variants emerge, there is an urgent need for vaccines that offer broader, more durable protection. CVXGA’s potential to provide long-term COVID-19 protection by boosting pre-existing immunity and generating mucosal, humoral, and cellular immune responses makes it a promising candidate for further clinical development.”
Preclinical Study on Long-Term Immunity in Nonhuman Primates
One of the published studies, titled “A parainfluenza virus 5 (PIV5)-vectored intranasal SARS-CoV-2 vaccine (CVXGA1) elicits protective and long-lasting immunity in nonhuman primates,” explored the immune responses induced by CVXGA1, a version of CVXGA expressing the S-protein of the ancestral WA1 (Wuhan) strain of SARS-CoV-2. The study utilized African green monkeys to evaluate the durability of the immune response.
Key findings from the study include:
- CVXGA1 elicited strong nasal IgA responses, critical for mucosal immunity.
- Sustained levels of IgG and IgA antibodies were detected beyond 245 days post-vaccination.
- Peripheral blood mononuclear cell (PBMC) responses persisted for at least 180 days, demonstrating a prolonged cellular immune response.
These findings are particularly significant given the challenges posed by waning immunity observed with currently available injectable COVID-19 vaccines. While mRNA vaccines have demonstrated strong initial protection, their effectiveness declines over time, necessitating frequent booster doses. The data suggest that CVXGA may offer a more durable alternative by targeting the mucosal immune system, which plays a crucial role in preventing respiratory infections at their entry point.
Efficacy as a Booster Against SARS-CoV-2 Variants
The second study, “Efficacy of parainfluenza virus 5 (PIV5)-vectored intranasal COVID-19 vaccine as a single-dose primer and booster against SARS-CoV-2 variants,” investigated the potential of CVXGA1 as a booster in a hamster model. This study evaluated the vaccine’s ability to enhance immunity in subjects that had previously received two doses of an mRNA vaccine.
Key findings from the hamster model study include:
- CVXGA1 provided robust protection against infection by the WA1 strain and multiple SARS-CoV-2 variants, including variants of concern.
- The vaccine significantly boosted pre-existing immunity in animals that had already received an mRNA vaccine.
- When compared to an additional booster dose of an mRNA vaccine, CVXGA1 provided superior protection, enhancing the immune response beyond serum antibodies alone.
These results underscore the versatility of intranasal vaccination, suggesting that CVXGA could be a valuable addition to the existing vaccination strategies, particularly as a booster that enhances immunity while addressing viral evolution.
Advantages of Intranasal COVID-19 Vaccines
The intranasal route of administration offers several advantages over traditional injectable vaccines:
- Targeted Mucosal Immunity: Intranasal vaccines stimulate immune responses in the mucosal tissues of the respiratory tract, where SARS-CoV-2 initially infects the body. This may lead to better prevention of infection and transmission.
- Longer-Lasting Protection: By engaging mucosal, humoral, and cellular immunity, intranasal vaccines may offer more sustained protection compared to systemic-only immune responses triggered by injections.
- Ease of Administration: Intranasal vaccines eliminate the need for needles, reducing barriers to vaccine acceptance and making mass immunization efforts more feasible.
- Potential for Broad-Spectrum Protection: Mucosal immunity has been shown to be more adaptable in responding to different variants, potentially providing broader protection against evolving SARS-CoV-2 strains.
Implications for Future Clinical Development
With these encouraging preclinical findings, Blue Lake Biotechnology and CyanVac are now focused on advancing CVXGA into clinical trials. The vaccine’s ability to provide durable immunity and serve as an effective booster against emerging variants could make it a critical tool in the ongoing fight against COVID-19.
Further clinical studies will be necessary to confirm these results in human populations, particularly to assess safety, dosage, and long-term immune responses. If successful, CVXGA could represent a major breakthrough in COVID-19 vaccination, offering a needle-free, long-lasting alternative that enhances global vaccination efforts.
