Revenue22 Apr 2026 07:44
HVIVO to conduct world's first pivotal phase III whooping cough human challenge trial
Published: 07:12 22 Apr 2026 BST
Written by: Ian Lyall
hVIVO PLC - hVIVO to conduct world's first pivotal Phase III whooping cough human challenge trial
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