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.

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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.

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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.

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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.