Blue Lake Biotechnology, Inc., a US-based clinical-stage biotechnology company, announced on Monday its preliminary interim data from a phase one clinical trial of its BLB201 vaccine to prevent severe respiratory syncytial virus (RSV)-associated disease (NCT05281263).

The preliminary data were revealed in an oral presentation by Dr Hong Jin, Blue Lake Biotechnology chief scientific officer, at the seventh International Conference on Vaccines Research & Development (Vaccines R&D-2022) in Boston, Massachusetts. Dr Jin revealed that data from the first study cohort indicated that 64% of subjects had increased serum anti-RSV antibody responses above their baseline levels. All participants were seropositive for RSV at baseline. If participants with the highest baseline levels of anti-RSV antibodies are excluded from the evaluation, the proportion of subjects that had increased anti-RSV antibody responses above baseline levels becomes 80%. Temporary shedding of vaccine after vaccination was detected in 21% of participants, indicative of self-limited vaccine replication.

The Phase one clinical trial, a multi-centre, open-label trial, is aimed at assessing the safety, reactogenicity and immunogenicity of a single dose of BLB201 administered as a nasal spray to 30 healthy adults in two sequential age cohorts in the age group of 18 to 59 years and age 60 to 75 years. It is being carried out in Cincinnati Ohio and Charleston South Carolina and headed by Dr Paul Spearman, director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.