In June 2024, hVIVO announced that it has signed a £2.5 million contract with a mid-sized pharmaceutical company to initiate an Omicron characterisation study. The study aims to identify a dose of hVIVO’s Omicron BA.5 challenge agent that establishes a “safe, measurable, and reproducible disease” in healthy volunteers with “sufficiently high infection rates” to be able to use the model to test the efficacy of antivirals and vaccines. hVIVO’s dedicated volunteer recruitment arm, FluCamp, will recruit healthy volunteers between the ages of 18 and 30 who have previously received a full course of a licenced COVID-19 vaccine.
“Characterisation studies offer numerous benefits to biopharma clients, including insights into specific pathogens that are more precise, actionable, and relevant to support and refine vaccine or antiviral development. They also provide the necessary data from which to design subsequent antiviral or vaccine efficacy testing studies.”
The study
hVIVO expects that the study will commence in Q4 2024, taking place at the new CL3 (containment level 3) quarantine facility in Canary Wharf. The facility was specifically designed to meet the highest hospital isolation suite standards suitable for CL3 pathogens and is equipped with advanced safety features such as physical containment barriers, controlled ventilation systems with negative pressure and HEPA filtration, and comprehensive waste management protocols.
This study is the first “COVID-related work” that hVIVO will be undertaking since the manufacture of the Omicron BA.5 challenge agent. Should the characterisation study be successful, and the company receive relevant regulatory approvals, hVIVO expects to conduct “multiple” Omicron human challenge trials to test the efficacy of medical products from mid-2025.
Diversifying challenge trial offerings
Chief Executive Officer of hVIVO, Yamin ‘Mo’ Khan, shared that “one of our key goals” is to “further diversify our challenge trial offerings”.
“The establishment of a COVID challenge model is a key step to penetrating a new and expanding market, especially with regards to mucosal and multi-valent COVID vaccine development.”
The study is to take place at the new site in Canary Wharf, which is the “largest human challenge trial quarantine clinic in the world and is highly specialised”.
“Securing this contract further validates the move to our new facilities and the new opportunities it brings for CL3 category projects.”
Dr Andrew Catchpole, Chief Scientific Officer, is “excited to begin work” on the challenge agent at the CL3 facilities.
“We have leading expertise in characterising SARS-CoV-2 challenge agents, having successfully conducted the world’s first COVID-19 characterisation study. The client funding towards this study demonstrates the strong interest and growing pipeline in this indication due to the continued risk that COVID-19, and particularly the Omicron strain, poses to global health and ongoing need for improved vaccines and treatments.”
For more from Dr Catchpole at the Congress in April, watch our interview here.
