hVIVO PLC (AIM:HVO) has been selected to carry out a large-scale phase III trial for a new whooping cough vaccine, BPZE1, developed by ILiAD Biotechnologies, a late-stage biotech development company
It is the world's first pivotal Phase 3 human challenge trial in Bordetella pertussis, the bacteria that causes whooping cough, and will expand hVIVO's area of expertise as well as being its largest challenge trial to date.
The trial is scheduled to commence in the second half of 2025 with ILiAD and hVIVO working on the final agreement, added the statement.
Whooping cough is particularly dangerous for babies under six months of age, causing serious and sometimes life-threatening complications.
Pertussis outbreaks are cyclical, hVIVO added, and there is currently a large increase in cases globally with cases in the US up by six times in 2024 versus 2023.
BPZE1 is being developed to block Bordetella pertussis from colonising the nasal passages of adults and children, to protect them from whooping cough, and to potentially prevent transmission, including to infants.
Mo Khan, hVIVO’s chief executive, said: "We are pleased to have been selected by ILiAD to conduct the world's first Phase 3 human challenge trial for a leading whooping cough vaccine candidate.
Keith Rubin, ILiAD Biotechnologies CEO added: "The limitations of current pertussis vaccines are evident, with cases reaching 10-year highs in both the US and Europe in 2024.
"By leveraging hVIVO's extensive experience and expertise in human challenge trials, we plan to generate robust pivotal clinical data to support global marketing authorisation applications for BPZE1.”