Blue Lake Biotechnology has announced initial results from a Phase 1/2a clinical trial of its BLB201 intranasal vaccine against severe respiratory syncytial virus disease in children aged 8 months to 59 months with or without prior RSV infection. The company has previously announced results from a Phase 1 trial BLB201 in adults aged 18-59 and 60-75. In 2022, the FDA granted Fast Track designation to BLB-201 for the prevention of RSV in children under 2 and adults over 60.
According to the company, data from the first 10 children, who were aged 18 months to 59 months, demonstrate that BLB201 produced an immune response and was well tolerated. No significant safety events have been reported.
Blue Lake CEO Biao He commented, “Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far. It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.”
He added, “For the first time, an RSV vaccine candidate has been shown to generate increases in anti-RSV antibody responses in RSV-seropositive children, suggesting that BLB201 could be effective even in infants who have pre-existing anti-RSV antibodies. This is particularly encouraging given that the target population of our vaccine includes infants under eight months old who may already have passive immunity to RSV from maternal antibodies or exogenously administered anti-RSV antibodies.”
Read the Blue Lake Biotechnology press release.
