ILiAD Biotechnologies and hVIVO will collaborate on a Phase 3 human challenge trial for ILiAD’s next-generation intranasal pertussis vaccine, BPZE1. This trial design was confirmed following a meeting with the FDA and offers a more efficient path to evaluate vaccine efficacy compared to traditional field studies, especially given the unpredictable nature of pertussis outbreaks. The companies have signed a Letter of Intent, and are working towards a final agreement.
This collaboration represents a significant advancement in pertussis vaccine development. Current vaccines, despite widespread use, have not effectively controlled pertussis outbreaks, which continue to pose a global health threat. A successful intranasal vaccine could offer several advantages, including easier administration and potentially improved protection against infection and transmission, particularly to infants who are most vulnerable to severe complications. This trial will expedite the evaluation of BPZE1, offering a potentially quicker route to regulatory approval and potentially addressing an unmet need in pertussis prevention.
The planned Phase 3 trial utilizes hVIVO’s expertise in human challenge studies, a model well-suited to infectious respiratory diseases. This approach allows for controlled exposure to the pertussis bacterium, enabling researchers to directly measure vaccine efficacy in preventing infection. ILiAD is actively pursuing funding to support the trial, with enrollment anticipated to begin in the second half of 2025.
This partnership and trial design mark a critical step in the development of BPZE1. A successful trial outcome could reshape the pertussis vaccine landscape, potentially leading to a more effective and accessible preventive measure against this persistent disease. The results of this study will be crucial in determining the potential impact of BPZE1 on global pertussis prevention and control efforts.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
