A decade of clinical trials has uncovered a hidden layer of insight into Respiratory Syncytial Virus (RSV) infection. In a unique and controlled environment, hVIVO’s data has unearthed rare, subclinical myocarditis cases—offering investors a glimpse into the precision and power of human challenge models to detect what traditional studies miss.
Over ten years of rigorous controlled human infection studies at hVIVO have illuminated a rare cardiac outcome associated with Respiratory Syncytial Virus (RSV). Out of more than 2,000 participants, just six cases—equating to a 0.3% incidence rate—exhibited signs of mild, subclinical myocarditis. These events were asymptomatic or presented minimal symptoms, and were only identified through the comprehensive monitoring protocols built into hVIVO’s RSV challenge studies.
The retrospective analysis focused on participants from studies between 2013 and 2021, isolating those who experienced myocarditis during the 12-day quarantine post-inoculation. By evaluating troponin levels, electrocardiograms (ECGs), CRP markers and MRI results, the hVIVO team demonstrated the strength of its methodology. Elevated troponin was the most consistent biomarker, with some ECG anomalies present, yet no participant experienced serious complications. Importantly, no long-term consequences were observed, reaffirming the safety profile of the RSV challenge model.
These findings not only affirm the robustness of hVIVO’s viral challenge platform but also present a compelling case for its utility in pre-empting rare adverse events that evade detection in standard clinical trials. The subclinical nature of these myocarditis cases highlights how hVIVO’s controlled environment can uncover potential safety signals for vaccines and antivirals far earlier in development, de-risking investment decisions and accelerating path-to-market timelines.
This strategic approach positions hVIVO at the forefront of human challenge trials, enabling deeper insights, earlier signal detection and enhanced confidence for drug and vaccine developers.
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.
