Blue Lake Biotechnology has reported positive interim findings from a Phase I clinical trial of its intranasal vaccine candidate, BLB201, to prevent severe respiratory syncytial virus (RSV)-linked disease.
The multicentre, open-label trial will assess the safety, reactogenicity, and immunogenicity of one dose of BLB201 given as a nasal spray.
It enrolled 30 healthy adult subjects in two age cohorts, comprising people aged 18-59 years and 60-75 years.
According to the initial data from the first trial cohort, 64% of participants showed a rise in serum anti-RSV antibody responses above the baseline levels.
All participants in the trial were seropositive for RSV at baseline, as anticipated.
On excluding people with greater anti-RSV antibody levels at baseline from the analysis, the proportion of participants with elevated anti-RSV antibody responses above baseline levels was 80%.
After inoculation, temporary shedding of the vaccine was reported in 21% of participants, signifying self-limited replication of the vaccine.
The shot was found to be well-tolerated so far by subjects in both age groups.
Limited or no reactogenicity without any substantial adverse safety signals were seen in the trial.
Blue Lake Biotechnology founder and CEO Dr Biao He said: “These initial Phase I results show that our PIV5 platform has an excellent safety profile so far and can stimulate pathogen-specific immune responses in humans.
“Considering the past experience of other intranasal vaccine platforms, I believe it is remarkable that we detected such a high percentage of antibody responses.
“In particular, it is exciting that RSV-positive adults responded with just a single intranasal dose of our vaccine.”
The BLB201 vaccine is based on a PIV5 vector expressing RSV’s F protein.
According to preclinical research, BLB201 was found to be immunogenic and avert RSV infection in animal challenge studies.
In July this year, the company enrolled the first subject in a Phase I trial of BLB-201.