Stablepharma Ltd. has initiated a Phase 1 clinical trial for its lead candidate, SPVX02, a fridge-free tetanus and diphtheria vaccine. The trial, funded by shareholders and the UK government, commenced on April 15, 2025, at the National Institute for Health and Care Research (NIHR) and is anticipated to conclude in Q3 2025. This marks the first time Stablepharma’s StablevaX™ technology, which reformulates vaccines into thermostable forms, eliminating the need for cold storage, has entered clinical trials.
This clinical trial is a crucial step towards addressing the significant global challenge of vaccine wastage due to cold chain failures. The World Health Organization estimates that over half of all vaccines are lost annually for this reason. A successful outcome would represent a substantial improvement in vaccine distribution, particularly in regions with limited access to reliable refrigeration. This could significantly increase vaccination rates for preventable diseases like tetanus and diphtheria, ultimately saving lives and improving global health outcomes.
SPVX02 has demonstrated stability and potency after repeated exposure to extreme temperature fluctuations, ranging from -20°C to +40°C. The clinical batch, produced in partnership with Thermo Fisher Scientific, has been approved for an 18-month shelf life at room temperature (up to 30°C). The company has also been awarded a €2.5 million grant from the European Innovation Council (EIC) Accelerator program, recognizing the potential impact of their technology. Furthermore, Stablepharma has identified 60 temperature-sensitive vaccines that could be reformulated using the StablevaX™ platform.
This Phase 1 trial represents a significant milestone for Stablepharma and the potential future of vaccine distribution. Positive results could pave the way for a commercially available fridge-free tetanus and diphtheria vaccine by 2027, potentially revolutionizing global vaccine delivery and accessibility. The potential application of StablevaX™ to other vaccines opens the door for a broader impact on global health, particularly in underserved communities. The trial’s progress and results will be key indicators of the technology’s viability and its potential to reshape the vaccine landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
