hVIVO plc (AIM: HVO), a contract research organisation specialising in human challenge clinical trials, announced on Monday that it has signed a letter of intent with ILiAD Biotechnologies to conduct the world's first pivotal Phase 3 human challenge trial for Bordetella pertussis, targeting ILiAD's next-generation whooping cough vaccine, BPZE1. The trial is set to commence in the second half of 2025.

BPZE1, ILiAD's lead vaccine candidate, aims to provide durable and comprehensive protection against Bordetella pertussis colonisation and disease, potentially reducing transmission, including to vulnerable infants. Current vaccines have struggled to control whooping cough outbreaks, which have seen a significant global resurgence. According to the CDC, US cases surged sixfold in 2024 compared to 2023.

This trial, expected to be hVIVO's largest to date, leverages its state-of-the-art facilities in London, including the world's largest commercial human challenge trial unit. hVIVO's expertise in human challenge models and its comprehensive early-stage clinical development services underpin this landmark collaboration.

ILiAD Biotechnologies, backed by over USD100m in funding, focuses on advancing innovative solutions for Bordetella pertussis. The upcoming study highlights the critical role of human challenge trials in overcoming traditional challenges associated with Phase 3 field studies for infectious diseases.