22nd Apr 2026 16:11
(Sharecast News) - hVIVO said on Wednesday that it has secured a contract to conduct what it described as the world's first pivotal phase three human challenge trial for a whooping cough vaccine, marking its largest study to date.
The AIM-traded group said it would run the trial for ILiAD Biotechnologies' BPZE1 vaccine candidate, targeting Bordetella pertussis, the bacterium that causes whooping cough.
It said the study was expected to enrol more than 500 healthy volunteers, making it the largest human challenge trial undertaken by hVIVO.
The company said the multi-year contract was expected to contribute significantly to revenues, with income recognition beginning in the first half of 2026 and the majority expected across 2026 and 2027.
It said the trial was also anticipated to be the highest-value human challenge study in hVIVO's history.
The study would assess BPZE1's efficacy in preventing infection compared with the current standard Tdap combination vaccine, with microbiology assays conducted at hVIVO's Canary Wharf laboratory.
hVIVO noted that traditional field studies for pertussis vaccines are difficult due to unpredictable outbreak patterns, positioning human challenge trials as a faster and more efficient route to generating pivotal data.
"This study represents a landmark moment for human challenge trials which can help to bring vital medicines to market faster," said chief executive Yamin Khan.
He added that the data generated is expected to support regulatory submissions to agencies including the US FDA, UK MHRA and the European Medicines Agency, highlighting "the growing recognition that HCTs can deliver rapid and high-quality data supporting global licensures."
Whooping cough remains a significant global health risk, particularly for infants, with an estimated 24 million cases annually and around 160,000 deaths among young children.
Despite high vaccination coverage, existing vaccines provide limited duration of protection, creating demand for more effective alternatives.
ILiAD's BPZE1 was described as a next-generation intranasal vaccine designed to prevent both infection and transmission, with the aim of providing more durable protection.
At 1549 BST, shares in hVIVO were up 2.17% at 9.4p.
Reporting by Josh White for Sharecast.com.
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