In the world of clinical research, few companies possess the operational muscle to deliver large-scale vaccine trials on accelerated timelines without compromising quality. hVIVO has just proven itself as one of those rare players. Partnering with a US-based biotech company, hVIVO took on the responsibility of executing a high-volume outpatient influenza vaccine trial involving approximately 5,000 participants across the US and UK. The UK target alone was formidable—1,000 participants needed to be recruited, screened, dosed, and followed for 26 weeks, all before the onset of flu season.
Despite the time-sensitive nature of the study, hVIVO’s team moved quickly from protocol delivery in June 2024 to recruitment kick-off in September 2024. This left a narrow window for feasibility assessments, operational planning, and resource mobilisation. What followed was a masterclass in agile clinical execution. hVIVO’s seamless coordination across pharmacy, laboratory services, recruitment, and site personnel ensured the study stayed on course. The team worked hand-in-hand with the sponsor’s clinical research associates, embedding them onsite to foster real-time collaboration and streamline communications.
Flexibility became the defining feature of hVIVO’s operational approach. Recognising the unpredictable turnout of participants—which fluctuated from as few as one or two to as many as 43 per session—the team adapted by running up to three dosing sessions a day, including weekends. These sessions were staffed by a carefully calibrated mix of nurses, doctors, clinical support staff, and phlebotomists, ensuring that every participant received high-quality care regardless of turnout variability.
hVIVO’s forward-thinking approach included conducting dry runs to optimise patient flow and facility usage before the trial even began. This pre-emptive planning allowed the team to handle high volumes efficiently while maintaining a smooth clinical process. Participants were screened through rigorous protocols involving blood tests, ECGs, BMI checks, and drug screening, followed by dosing and observation. Each was trained on how to self-monitor using home assessment kits and e-diaries, maximising data collection during the follow-up period.
Operational challenges such as extended waiting times were addressed with practical solutions like providing snacks to keep participants engaged and reduce dropout risk. The clinical administration team expertly managed documentation and triggered medical assessments when needed, ensuring no detail was overlooked. Simultaneously, hVIVO’s data management team ensured all clinical data were transferred seamlessly into the sponsor’s electronic systems, maintaining data integrity throughout.
hVIVO’s expertise in virology played a pivotal role in enhancing study outcomes. Their specialist scientists advised on sample collection and preservation techniques, ensuring that every sample provided maximum data value. Their operational modelling capabilities, based on years of experience running challenge trials, allowed them to predict recruitment rates, staffing needs, and resource allocations with impressive accuracy. This allowed the team to make real-time adjustments and maintain momentum throughout the trial.
Key performance metrics speak volumes about hVIVO’s capabilities. In just over six weeks, the team screened more than 1,100 participants and successfully dosed 817—an achievement made even more remarkable given the study’s scale and tight timelines. Screening exclusions were handled transparently, with around 40% disqualified due to medical history, 15% due to positive drug tests, and 25% based on health metrics such as BMI and vital signs.
This successful execution underscores hVIVO’s position as a premier clinical research organisation capable of delivering complex, large-scale vaccine trials with unmatched agility. The ability to adapt to fluctuating participant numbers, optimise operational resources, and deliver high-quality clinical outcomes within compressed timelines highlights hVIVO’s operational excellence and scientific leadership.
hVIVO plc (formerly Open Orphan plc) 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.
