hVIVO (AIM:HVO) has contracted with ILiAD Biotechnologies, to run a pivotal Phase III human challenge trial testing BPZE1 against current Tdap vaccination. The study will be the first pivotal Bordetella pertussis HCT and is expected to recruit over 500 healthy volunteers through hVIVO's FluCamp-the company's largest HCT to date.
It is described as a multi‑year contract and revenue recognition is expected from H1 2026, with the majority of income due in 2026 and 2027.
hVIVO said it has spent the past year developing the bacterial assays with ILiAD; its Canary Wharf bacterial laboratory will run the microbiology assays for the primary and key secondary endpoints. The trial measures BPZE1's ability to prevent colonisation-an outcome conventional field trials struggle to capture because pertussis outbreaks are unpredictable.
"This study represents a landmark moment for human challenge trials which can help to bring vital medicines to market faster. We are pleased that data generated from this trial will be used in ILiAD's future marketing applications for BPZE1 to the US FDA, UK MHRA, EMA and other global regulatory agencies, underlining the growing recognition that HCTs can deliver rapid and high-quality data supporting global licensures.This approach has the potential to accelerate the development of future vaccines and antiviral therapies, in other indications with unpredictable seasonality, ultimately, bringing important medicines to patients faster," Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said.
Dr. Keith Rubin, Chief Executive Officer of ILiAD Biotechnologies, added: "We greatly appreciate the partnership with hVIVO to initiate our pivotal Phase III human challenge trial for BPZE1, a vaccine with the potential to address a major global unmet medical need. This is a highly innovative, world-first Phase III human challenge trial, and we're confident that hVIVO has the experience and expertise to deliver a rigorous and well-executed study. We expect this trial to generate important pivotal data to form a core part of our global marketing authorisation applications for BPZE1and to accelerate access to this urgently needed vaccine."
