Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, announced the enrollment of the first participant in a Phase 1 clinical trial of their intranasal BLB-201 vaccine for RSV (respiratory syncytial virus) in Charleston, South Carolina.
In preclinical studies, BLB-201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective against RSV challenge infection in various animal models.
Delivered through the nose without injections, Blue Lake's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant individuals.
"The enrollment of the first participant in this RSV vaccine study is an important milestone for Blue Lake," said Dr. Biao He, founder and CEO. "We now have two clinical stage programs – 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."
The study is a multi-center, open-label trial being conducted in Charleston as well as Cincinnati, Ohio.
It will evaluate the safety, reactogenicity and immunogenicity of a single dose of BLB-201 administered intranasally to adults in the age groups of 18-59 and 60-75.
Safety data will be collected and analyzed, as will antibody and cellular immune responses to the RSV F protein.
RSV is a highly contagious respiratory virus that infects more than 64 million people worldwide each year.