Iliad Biotechnologies announced that it has published data from a Phase 2b challenge study of its BPZE1 live-attenuated intranasal pertussis vaccine and said that the vaccine induced nasal mucosal and serum immune responses, with 90% of participants who received a single dose of BPZE1 protected from colonization following a challenge with attenuated B. pertussis at 3 months post vaccination. The data were published in The Lancet issue for March 11, 2023.
According to Illiad, the trial enrolled 300 healthy volunteers aged 18 to 50 who received a single dose of either BPZE1 or the Boostrix intramuscular Tdap vaccine followed by a challenge 85 days later with either BPZE1 or placebo. The company says that BPZE1 induced broad mucosal immunity that persisted for the 9 months of the study, while Boostrix failed to induce broad mucosal immunity or prevent colonization.
Iliad licensed the pertussis vaccine from French research institute Inserm in 2014. BPZE1 received Fast Track designation from the FDA in January 2022.
Iliad Chief Medical Officer Stephanie Noviello said, “In contrast to Boostrix, BPZE1 demonstrated both protection against attenuated Bordetella pertussis colonization and induction of pertussis-specific mucosal immune responses. In addition, BPZE1 demonstrated a favorable safety profile in this study. These data support the continued development of BPZE1.”
CEO Keith Rubin commented, “The publication of these data in The Lancet, one of the most respected peer-reviewed medical journals in the world, is consistent with the quality of our Phase 2b study and the potential major public health impact of BPZE1. These data add to the robust body of evidence supporting the potential of BPZE1 to address the limitations of current pertussis vaccines and to greatly reduce morbidity and mortality due to Bordetella pertussis on a global scale.”
Read the Iliad Biotechnologies press release.
Read the Lancet article.
