ILiAD Biotechnologies and hVIVO plc have announced a collaboration to conduct a pivotal Phase 3 human challenge trial for ILiAD's BPZE1 vaccine, a next-generation intranasal pertussis vaccine. Following a Type C meeting with the FDA in December 2024, the companies signed a Letter of Intent (LOI) to initiate the trial in the second half of 2025.
The trial aims to evaluate the efficacy of BPZE1 against Bordetella pertussis, the bacterium responsible for whooping cough. hVIVO, a specialist contract research organization (CRO), will leverage its expertise in human challenge models to overcome the complexities associated with traditional Phase 3 field studies, which are often hindered by the unpredictable nature of pertussis outbreaks.
Addressing a Critical Unmet Need
Pertussis remains a significant global health concern, affecting approximately 16 million people each year and causing nearly 200,000 deaths, according to the U.S. Centers for Disease Control and Prevention. Despite a global vaccination coverage of 84%, current vaccines have not effectively controlled epidemics, highlighting the need for improved preventative measures.
"We welcome the opportunity to partner with hVIVO, a CRO with extensive experience in human challenge studies, particularly those evaluating vaccines and medicines against infectious respiratory pathogens," said Keith Rubin, M.D., Chief Executive Officer and Founder of ILiAD.
BPZE1: A Novel Approach to Pertussis Prevention
BPZE1 is a live-attenuated vaccine designed to induce comprehensive and durable protection against B. pertussis infection and disease. The intranasal vaccine is designed to block B. pertussis from colonizing the nasal passages, protecting individuals from whooping cough and potentially preventing transmission, including to vulnerable infants. ILiAD is initially focused on direct protection for adults and children, with future development aimed at directly immunizing neonates.
Trial Design and Objectives
The Phase 3 human challenge trial is designed to assess the efficacy of BPZE1 in a controlled setting. By using a human challenge model, researchers can directly evaluate the vaccine's ability to prevent B. pertussis infection and disease manifestation. This approach offers a more efficient and reliable assessment compared to traditional field studies, which are subject to the variability of natural outbreaks.
The study is expected to commence in the second half of 2025, pending finalization of the definitive agreement and ILiAD's ongoing financing initiatives. The results of this trial could pave the way for regulatory approval and the introduction of BPZE1 as a new tool in the fight against whooping cough.
