hVIVO has signed what is set to be its largest ever human challenge trial, a pivotal Phase III study for ILiAD Biotechnologies’ whooping cough vaccine candidate BPZE1, involving more than 500 participants.
The AIM-listed clinical development specialist expects to begin recognising revenue from the contract in the first half of 2026, with the bulk flowing through during 2026 and 2027.
Management described the deal as a strong contributor to near- and mid-term revenues.
Investors cheered the news and hVIVO shares rose 8%, trading briefly above 10p for the first time since the beginning of March.
The trial will be the first pivotal Phase III human challenge study ever conducted in Bordetella pertussis, the bacterium that causes whooping cough.
It will measure BPZE1’s efficacy against the current standard of care Tdap combination vaccine, with volunteers recruited through hVIVO’s FluCamp arm.
The microbiology work underpinning the primary and key secondary endpoints will be handled at the Company’s bacterial laboratory in Canary Wharf, built out over the past year in close collaboration with ILiAD.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “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.”