hVIVO, a subsidiary of the specialist contract research organisation, Open Orphan (ORPH) has identified over 180 virus candidates and 12 different viral strains that could be used as part of a recently launched project to manufacture novel challenge agents for human trials.
The 'STRiVE' project’s aim (Seasonal Transmissible Respiratory Virus SurvEy) is to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees.
The collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.
Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials, it noted.
As part of STRiVE, volunteers with cold or flu-like symptoms can send nasal swabs to hVIVO for analysis. Viruses isolated include, inter alia, several strains of coronavirus, adenovirus, human metapneumovirus, parainfluenza virus, influenza and respiratory syncytial virus.
hVIVO explained to its shareholders that the STRIVE project can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. It added that manufacturing antigenically relevant strains on demand ‘broadens its repository of viral pathogens and could help extend the range of human challenge models it currently offers.’
The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. hVIVO says using human challenge modelling to better understand such issues could enable future public health benefits and savings.
This is largely due to the fact that despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity, the group told investors.
Open Orphan’s Executive Chairman Cathal Friel said: “Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials.”
He added: “I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research. Importantly, the STRIVE clinical research project will play a significant role in the Company’s efforts to broaden its world leading portfolio of human challenge models.”
Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, said: “Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent.”
He said STRIVE will allow hVIVO to monitor the viral strains of cold and flu that are circulating in the community, “and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field.”
Earlier this month, Open Orphan published the results from the world’s first COVID-19 human challenge characterisation study, a partnership that had been led by its hVIVO subsidiary.
The study, which was funded by the UK Vaccine Taskforce and Department of Health and Social Care (DHSC), with Imperial College London as the UK government’s study sponsor, took place at the National Infectious Disease Facility at the Royal Free Hospital in London.
As part of the study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. Results showed that it is safe to conduct COVID-19 human challenge studies in young volunteers.
Overall, no serious adverse events (SAEs) occurred, and the SARS-CoV-2 human challenge study model was shown to be safe and well tolerated in healthy young adults, it told investors.
With the study disease modelling data completed, and a COVID-19 Human Challenge Model now established, Open Orphan should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals, it outlined.
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