Blue Lake and CyanVac Publish Phase 1 Data for Intranasal COVID-19 Vaccine Candidate
Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company, and its affiliate CyanVac LLC have announced the publication of the full Phase 1 clinical study data for their COVID-19 vaccine candidate CVXGA in Science Advances. The results highlight the vaccine’s potential to safely trigger robust immune responses through an intranasal delivery method, offering a promising new tool in the ongoing fight against COVID-19.
A Novel Vaccine Platform Using PIV5
CVXGA is based on the parainfluenza virus 5 (PIV5) vector platform, an innovative technology designed to stimulate a broad immune response. Unlike traditional injected vaccines, CVXGA is delivered via the nose, targeting mucosal tissues that are often the first line of defense against respiratory viruses.
“Our vaccine candidates are designed to activate the three pillars of immunity — humoral, cellular, and mucosal,” said Dr. Biao He, founder and CEO of Blue Lake and CyanVac. “By stimulating all three, we aim to not only prevent illness but also reduce transmission of the virus — and we’re achieving this while maintaining a favorable safety profile.”
Phase 1 Study Design and Population
The open-label Phase 1 trial, titled “Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)-vectored COVID-19 vaccine in adults and teens in an open label Phase 1 trial,” enrolled 72 healthy volunteers between the ages of 12 and 51. Subjects were divided into four groups:
- Group 1 received a low dose of 10⁶ plaque forming units (PFU)
- Groups 2, 3, and 4 received a high dose of 10⁷ PFU
Each participant received a single intranasal dose of CVXGA1, a version of the vaccine expressing the spike protein from the ancestral WA1 strain of SARS-CoV-2.
Strong Immune Responses Observed
The study demonstrated that CVXGA1 was well tolerated at both dosage levels, with no significant safety concerns reported. More importantly, it triggered robust immune responses across multiple dimensions:
- CD8+ T cell responses: Four weeks after vaccination, 92% of participants in the low-dose group and 89% in the high-dose groups showed CD8+ T cell activity specific to the SARS-CoV-2 spike protein.
- Mucosal immunity: Among high-dose recipients, 31% to 41% developed at least a three-fold increase in spike-specific nasal antibodies, while 14% of low-dose recipients showed the same.
- Serum antibody response: CVXGA1 was able to both prime and boost systemic antibody levels, adding to its potential as a standalone or booster vaccine.
This combination of mucosal, cellular, and systemic immunity sets CVXGA apart from traditional injected COVID-19 vaccines and could help reduce both infection and transmission.
Vaccine Effectiveness at 7.3 Months
Perhaps most notably, the study revealed preliminary efficacy signals from a post-hoc analysis comparing symptom outcomes between dosage groups. Among adults, the high-dose group demonstrated a 67.8% relative vaccine effectiveness against symptomatic COVID-19 at a median of 7.3 months post-vaccination compared to the low-dose group (p = 0.048).
This level of durability and effectiveness, especially from a single-dose, intranasal vaccine, is a significant finding. According to the authors, these results compare favorably with intranasal COVID-19 vaccines approved outside the U.S.
Potential Impact on Public Health
With COVID-19 continuing to cause illness and hospitalizations globally, vaccines that reduce side effects, extend protection, and lower transmission are urgently needed.
“COVID vaccines that provide long-lasting protection and diminish transmission of the virus would be highly desirable,” said Dr. Paul Spearman, Professor of Infectious Diseases at Cincinnati Children’s Hospital Medical Center and principal investigator of the Phase 1 trial.
“The data published on CVXGA1 show significant potential for this novel intranasal approach — particularly the 67%+ effectiveness seen after seven months.”
Intranasal vaccines like CVXGA also offer the potential for needle-free administration, which can improve uptake, especially in children and needle-averse populations.
Next Steps in Development
The promising data from this Phase 1 trial support further clinical development of CVXGA. Blue Lake and CyanVac are expected to advance to larger, placebo-controlled trials to further evaluate safety, immunogenicity, and efficacy.
The PIV5 vector platform is also being used by Blue Lake to develop vaccines for other respiratory diseases, potentially positioning the company as a leader in next-generation, intranasal vaccine technology.
About CVXGA
CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough 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 serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 and Phase 2a clinical studies have shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious adverse events assessed as related to the vaccine.
About CyanVac and Blue Lake Biotechnology
Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our vaccines mimic natural infections by expressing a protein from a targeted pathogen in a proprietary parainfluenza virus 5 vector.
Clinical data have shown that administration of our intranasal vaccine candidates stimulates all three pillars of the immune system, including mucosal immunity, which may be beneficial in preventing transmission of pathogens and spread of disease. We have a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for efficacy against symptomatic infection following a single intranasal dose, with few vaccine-related side effects.
Learn more at CyanVac and Blue Lake Biotechnology.
