Blue Lake Biotechnology announced positive preliminary data from its Phase 1/2a clinical study of BLB201, an intranasal vaccine candidate against respiratory syncytial virus (RSV), in infants and young children. The data, derived from the first 63 participants, indicate a significant reduction in symptomatic RSV infections among those who received BLB201 compared to placebo.
The double-blind, placebo-controlled study (NCT05655182) revealed that participants who received BLB201 were more than 80% less likely to contract symptomatic RSV infections than those who received placebo (p<0.05). Importantly, the vaccine was well-tolerated, with no reported vaccine-related medically-attended adverse events or serious adverse events.
Distinct Immune Response
BLB201, a parainfluenza virus 5 (PIV5)-vectored vaccine, elicits moderate serum antibody responses and stimulates mucosal and cellular immune responses. This immune response is believed to be responsible for the vaccine’s protective activity and differs from injectable formalin-inactivated and mRNA-based RSV vaccines, which have been associated with vaccine-associated enhanced respiratory disease (VAERD).
"The preliminary analysis showing a greater than 80% reduction in the risk of symptomatic RSV infection underscores the promise of BLB201 as a safe and effective vaccine in preventing symptomatic RSV disease in infants and young children," said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology.
Addressing a Critical Need
RSV is a common respiratory virus that leads to significant morbidity and mortality in infants and young children. According to the Centers for Disease Control, RSV infections result in up to 80,000 hospitalizations and 10,000 deaths each year in children under five years old and older adults in the US.
While antibody drugs and maternal RSV vaccines exist to provide passive immunity, there is currently no approved vaccine for generating prophylactic immunity against RSV in infants and children. BLB201 aims to fill this gap by providing a safe and effective means of preventing RSV infection in this vulnerable population.
Trial Design and Ongoing Assessment
The Phase 1/2a study is designed to enroll up to 137 RSV seropositive and seronegative infants and young children between eight and 59 months old. To date, 38 children have received either a single low dose or a single high dose of BLB201, and 25 children have received placebo. The primary and secondary endpoints include assessments of safety, tolerability, and immunogenicity, with exploratory endpoints assessing the proportion of participants diagnosed with symptomatic RSV infection. The trial is ongoing, with some participants still within the 12-month follow-up period.
"In addition to the overall excellent tolerability and safety of BLB201 in infants and young children so far, it is reassuring that we have not detected any safety signals of VAERD," said Henry Radziewicz, M.D., chief medical officer of Blue Lake Biotechnology.
