ILiAD Biotechnologies Reports First-ever Demonstration of Protection Against B. pertussis Colonization in Phase 2b Human Challenge Study of BPZE1 Vaccine
ILiAD Biotechnologies reported today that its BPZE1 intranasal pertussis vaccine has met the primary endpoint of protection against nasopharyngeal B. pertussis colonization (p=0.03) in the Phase 2b CHAMPION-1 Study.
- ILiAD Biotechnologies reported today that its BPZE1 intranasal pertussis vaccine has met the primary endpoint of protection against nasopharyngeal B. pertussis colonization (p=0.03) in the Phase 2b CHAMPION-1 Study.
- The CHAMPION-1 Phase 2b Human Challenge study is a randomized, double-blind, placebo-controlled study of BPZE1 vaccine in healthy adults.
- The study has a primary objective to demonstrate that prior immunization with BPZE1 protects against colonization as evidenced by negative B. pertussis culture following virulent B. pertussis challenge 2–4 months after vaccination.
- As a result, the preparation method of the B. pertussis challenge dose was modified to achieve the per-protocol adequate inoculum of B. pertussis challenge as specified in the original study protocol.