hVIVO Secures Landmark Phase III Whooping Cough Vaccine Trial and £6M Influenza Drug Contract
核心洞察
hVIVO has signed a contract to conduct the world's first pivotal Phase III human challenge trial for BPZE1, a whooping cough (搜索) vaccine candidate developed by ILiAD Biotechnologies (搜索).
The company also secured a £6 million agreement to test a monoclonal antibody (搜索) treatment for influenza (搜索) in a randomized, double-blinded, placebo-controlled human challenge trial.
The whooping cough (搜索) trial will involve more than 500 healthy volunteers and represents hVIVO's largest HCT to date, with revenue recognition expected across 2026 and 2027.
hVIVO PLC has secured two major contracts that underscore the growing role of human challenge trials in accelerating pharmaceutical development, including the world's first pivotal Phase III human challenge trial for a whooping cough (搜索) vaccine.
Groundbreaking Whooping Cough Vaccine Trial
The company has signed a contract to conduct what it describes as the first ever pivotal Phase III HCT for a whooping cough (搜索) vaccine. The trial will test BPZE1, a vaccine candidate developed by US biotech ILiAD Biotechnologies (搜索), 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." 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. 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.
Addressing Critical Medical Need
Whooping cough (搜索) 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.
£6 Million Influenza Drug Contract
In addition to the whooping cough (搜索) trial, hVIVO has signed a £6 million agreement to test a monoclonal antibody (搜索) treatment for influenza (搜索) on behalf of an unnamed clinical-stage biopharmaceutical company. The contract covers a randomised, double-blinded, placebo-controlled human challenge trial.
The study will take place at hVIVO's quarantine facilities in Canary Wharf, London, with participants recruited through the company's FluCamp arm and laboratory analysis conducted in-house by its specialist virology team. Revenue from the contract will be recognised across 2026 and 2027, with the study expected to begin this year.
Clinical Operations and Revenue Impact
The company expects to begin recognising revenue from the whooping cough (搜索) 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.
Proven Track Record
hVIVO has to date inoculated more than 5,000 healthy volunteers across 2,477 challenge trials covering influenza (搜索), RSV and other respiratory viruses. Chief scientific officer Andrew Catchpole said the company's influenza challenge model is designed to characterise how a virus behaves in the body and how the immune system responds, enabling early-stage assessment of new drugs.
Seasonal influenza (搜索) affects an estimated one billion people annually, causing between three million and five million severe cases and up to 650,000 deaths each year. Khan said hVIVO's integrated model, combining recruitment, clinical operations and virology analytics, allows clients to evaluate novel assets "rapidly and rigorously."