Blue Lake Biotechnology Inc. has reported promising preliminary results from its Phase 1 clinical trial of an experimental nasal COVID-19 vaccine, showing 86% efficacy in reducing symptomatic infections over three months when used as a booster dose. The Athens, Georgia-based startup's vaccine significantly outperformed existing mRNA boosters, which reduce symptomatic infections by 43% in people aged 18 to 49 over one to two months, according to a Centers for Disease Control and Prevention study published in November.
The Phase 1 trial, which began in August 2021, enrolled 72 participants aged 18 to 55, including individuals who had already received at least two doses of mRNA vaccines and unvaccinated healthy adults. Data collection from participants continues through December, with findings released earlier this month representing preliminary but encouraging results.
Novel Vaccine Platform and Mechanism
The vaccine employs a modified parainfluenza virus encoded with the coronavirus spike protein to train the immune system. The same parainfluenza virus platform, engineered to be non-pathogenic, is currently used in veterinary vaccines to protect dogs against kennel cough. Once inhaled, the virus replicates within the nasal cavity for several days at levels sufficient to trigger immune responses without causing illness.
"When we crunched the numbers, we had longer duration and better protection than mRNA vaccines — that's very exciting," said Biao He, founder and CEO of Blue Lake Biotechnology and professor of infectious diseases at the University of Georgia College of Veterinary Medicine. "This is only Phase 1 and we need to do at least three phases, but we're very encouraged and excited about this."
Advantages of Nasal Delivery
The nasal administration approach offers theoretical advantages over intramuscular injection by establishing immune protection at the primary site of viral entry. Dr. Benjamin Goldman-Israelow, assistant professor of medicine at Yale School of Medicine who is not involved with Blue Lake's trials, explained that nasal vaccines "bolster immune protection right where the virus enters the body, setting up a more targeted line of defense."
Goldman-Israelow's own research, published in October in the journal Science, demonstrated that nasal vaccine boosters induced stronger immune responses in the upper airway and provided superior protection against COVID-19 infections compared to intramuscular vaccines in animal models.
The respiratory system's specialized immune surveillance mechanisms contribute to this enhanced protection. "Your lungs are always encountering what you breathe in, and if they responded really violently and had intense immune responses against everything they encountered, you wouldn't be able to breathe," Goldman-Israelow noted, explaining how the respiratory tract distinguishes between genuine threats and benign substances.
Safety Profile and Tolerability
Phase 1 participants experienced notably fewer side effects compared to traditional COVID-19 vaccines. While injected vaccines commonly cause flu-like symptoms including sore arms, muscle aches, and fever, Blue Lake's nasal vaccine produced only mild effects such as runny nose or no adverse reactions at all.
"The side effects from other vaccines may have discouraged some people from getting it, but in the testing we've done so far, our vaccine was very well tolerated," He reported.
Development Timeline and Global Context
Blue Lake plans to initiate Phase 2 trials soon, expanding enrollment to approximately 400 participants across the United States and Europe. The company represents one of only two nasal COVID-19 vaccines to reach human trials in the United States, alongside a candidate from Mount Sinai researchers in New York City.
While nasal COVID-19 vaccines have gained regulatory approval in India, Iran, and Russia, with two additional versions in use in China and an inhalable booster approved in September, limited efficacy data from these programs has been publicly disclosed.
He expressed optimism that positive results could accelerate funding for nasal vaccine development beyond COVID-19 applications. "I hope more positive results will spur additional funding to develop and test nasal vaccines — not just for Covid, but also other diseases," he stated.
The preliminary results offer early evidence that next-generation vaccine platforms could provide more effective and durable protection against respiratory pathogens, though larger-scale trials will be necessary to confirm these initial findings and support regulatory approval.
