In June 2024, hVIVO announced a £2.5 million contract with a mid-sized pharmaceutical company to launch an Omicron characterisation study. This study aims to determine a dose of hVIVO’s Omicron BA.5 challenge agent that establishes a “safe, measurable, and reproducible disease” in healthy volunteers, ensuring high infection rates necessary for testing the efficacy of antivirals and vaccines. hVIVO’s recruitment arm, FluCamp, will enlist healthy volunteers aged 18 to 30 who have received a full course of a licenced COVID-19 vaccine.
Characterisation studies offer numerous benefits to biopharma clients, including precise and actionable insights into specific pathogens, which support and refine vaccine or antiviral development. These studies provide essential data for designing subsequent antiviral or vaccine efficacy testing studies.
hVIVO anticipates the study will begin in Q4 2024 at the new CL3 (containment level 3) quarantine facility in Canary Wharf. This facility meets the highest hospital isolation suite standards suitable for CL3 pathogens, 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 represents the first COVID-related work hVIVO will undertake since manufacturing the Omicron BA.5 challenge agent. If successful, and with the necessary regulatory approvals, hVIVO expects to conduct multiple Omicron human challenge trials to test medical products’ efficacy from mid-2025.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, expressed the company’s aim to further diversify their challenge trial offerings. Establishing a COVID challenge model is a key step towards entering a new and expanding market, especially in the context of mucosal and multi-valent COVID vaccine development. The study will be conducted at the new site in Canary Wharf, which is the largest human challenge trial quarantine clinic globally and highly specialised. Securing this contract further validates the move to the new facilities and the opportunities it brings for CL3 category projects.
Dr Andrew Catchpole, Chief Scientific Officer, is eager to begin work on the challenge agent at the CL3 facilities. With leading expertise in characterising SARS-CoV-2 challenge agents, hVIVO has successfully conducted the world’s first COVID-19 characterisation study. The client funding for this study highlights the strong interest and growing pipeline in this indication due to the continued risk that COVID-19, particularly the Omicron strain, poses to global health, and the ongoing need for improved vaccines and treatments.
hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
