hVIVO (HVO) has signed a contract with ILiAD Biotechnologies to conduct the world’s first pivotal Phase III human challenge trial for a whooping cough vaccine candidate, BPZE1.
Watch: hVIVO Lands Landmark Phase III Trial
The study will assess the efficacy of BPZE1 in preventing infection caused by Bordetella pertussis, the bacterium responsible for whooping cough. It is expected to enrol more than 500 healthy volunteers, making it hVIVO’s largest human challenge trial to date.
The trial will compare BPZE1 against the current standard Tdap combination vaccine. Participants will be recruited through hVIVO’s FluCamp platform, while microbiology assays will be conducted at the company’s Canary Wharf laboratory.
hVIVO expects to begin recognising revenue from the contract in the first half of 2026, with the majority of income anticipated across 2026 and 2027. As a result, the multi-year agreement is set to make a strong contribution to both near- and mid-term revenues.
The company noted that traditional field studies for pertussis vaccines are difficult due to unpredictable outbreak patterns and high baseline vaccination rates. Human challenge trials offer a faster and more efficient route to generate pivotal efficacy data with fewer participants.
Whooping cough remains a significant global health concern, particularly for infants under six months. Cases in the UK rose sharply in 2024, increasing 17-fold year-on-year, while globally the disease is estimated to cause about 24 million cases and 160,000 deaths annually among young children.
BPZE1 is a next-generation, needle-free intranasal vaccine designed to provide longer-lasting protection by preventing bacterial colonisation in the nasal passages, with the potential to also reduce transmission.
hVIVO’s Chief Executive Officer Yamin ‘Mo’ Khan 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.”
View from Vox
This is a landmark contract for hVIVO, both scientifically and commercially. Not only is it the company’s largest human challenge trial to date, but it also positions hVIVO at the forefront of using challenge models in late-stage vaccine development.
The scale of the study and multi-year revenue visibility provide a clear boost to earnings through 2027. If successful, the trial could further validate human challenge trials as a faster route to approval in complex infectious diseases, potentially opening up additional high-value opportunities for hVIVO.