Blue Lake Biotechnology has announced the first subject enrolment in a Phase I clinical trial of BLB-201, its intranasal vaccine to treat respiratory syncytial virus (RSV).
Based on an attenuated PIV5 strain expressing the RSV F protein, the vaccine obtained the US Food and Drug Administration Fast Track designation to prevent acute disease associated with RSV in adults and paediatric populations.
Blue Lake Biotechnology founder and CEO Dr Biao He said: “The enrolment of the first participant in this RSV vaccine study is an important milestone for Blue Lake.
“We now have two clinical stage programmes – a Covid-19 vaccine and an RSV vaccine using our intranasal PIV5-vectored vaccine platform, which we expect will confirm the broad utility of our platform.”
Being conducted in Cincinnati, Ohio and Charleston, South Carolina in the US, the open-label, multi-centre trial will analyse the reactogenicity, immunogenicity and safety of a single BLB-201 dose.
The vaccine will be given intranasally as a spray to adults in two sequential age cohorts of 18 to 59 years and 60 to 75 years.
The company will then collect and analyse the trial’s safety data.
BLB-201 encodes a full-length RSV F protein and makes use of a PIV5 vector. In preclinical studies, it was found to be immunogenic.
BLB-201 is being developed by Blue Lake Biotechnology and CyanVac as a single dose, intranasal vaccine for the prevention of acute and severe disease associated with RSV, a highly contagious and common respiratory virus.
No preventive vaccine or antiviral treatment is currently approved for the disease.
