hVIVO PLC (AIM:HVO) has signed a contract to run what it says is the first ever pivotal Phase III HCT for a whooping cough vaccine.
The trial will test BPZE1, a vaccine candidate developed by US biotech ILiAD Biotechnologies, for its ability to prevent infection by Bordetella pertussis, the bacterium that causes whooping cough.
Chief executive Yamin 'Mo' Khan said the study represents "a landmark moment for human challenge trials which can help to bring vital medicines to market faster."
HCTs deliberately expose healthy volunteers to a pathogen under controlled conditions, allowing researchers to assess a vaccine's efficacy more quickly and with fewer participants than conventional field studies.
The trial is anticipated to involve more than 500 healthy volunteers recruited through hVIVO's FluCamp participant arm, making it the company's largest HCT to date.
BPZE1's efficacy will be measured against the existing standard-of-care Tdap (tetanus, diphtheria and pertussis) combination vaccine.
hVIVO said data generated from the trial will support ILiAD's future regulatory submissions to the US Food and Drug Administration, the UK's Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency, among others.
The company said it expects to begin recognising revenue from the contract in the first half of 2026, with the majority falling across 2026 and 2027.
hVIVO described the multi-year deal as its largest-value HCT contract to date, saying it will make a strong contribution to near- and mid-term revenues.
The company has spent the past year working with ILiAD to develop bacterial assays for the study, and its microbiology laboratory in Canary Wharf will conduct assays for the trial's primary and key secondary endpoints.
Whooping cough poses a serious risk, particularly to infants under six months of age, and outbreaks are cyclical but unpredictable.
UK cases rose 17-fold in 2024 compared with 2023, while a 2017 study estimated the global burden at 24 million cases per year, with 160,000 deaths among young children.
Despite 85% vaccination coverage worldwide, the protection offered by current vaccines is known to wane relatively quickly, leaving communities increasingly vulnerable between outbreak cycles.