UK biotechnology company Stablepharma Ltd has initiated a Phase 1 clinical trial for its groundbreaking fridge-free tetanus and diphtheria vaccine (SPVX02), following approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The first-in-human trial, led by Professor Saul Faust, is being conducted at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility. The first participant received a dose on April 15, 2025, with the study expected to conclude in Q3 2025.
Revolutionary Thermostable Vaccine Technology
Stablepharma's proprietary StablevaX™ technology platform reformulates vaccines to eliminate cold chain requirements, addressing a critical global healthcare challenge. The World Health Organization estimates that over 50% of vaccines worldwide are wasted annually due to cold chain failures, highlighting the potential impact of this innovation.
Dr. Karen O'Hanlon, Chief Development Officer at Stablepharma who is leading the trial with Professor Faust, emphasized the significance of this milestone: "Our team have worked tirelessly to reach the start of this phase 1 trial with SPVX02 - it marks a pivotal moment for Stablepharma, as we advance into the clinical development phase with the world's first fridge-free Td vaccine, a groundbreaking innovation in vaccine technology."
The company has demonstrated that SPVX02 maintains stability and potency after three cycles of extreme temperature fluctuations, ranging from -20°C to +40°C. Most conventional vaccines require constant refrigeration between 2-8°C, while some biologics need storage at -20°C.
"We are very pleased that a room temperature (up to 30°C) shelf life of 18 months has been approved for the current clinical batch of SPVX02, manufactured in collaboration with our partner CDMO Thermo Fisher Scientific, for the phase 1 study," added Dr. O'Hanlon.
Addressing Global Vaccine Distribution Challenges
Cold chains are complex, costly, and energy-intensive systems that contribute significantly to carbon emissions. When these temperature-controlled supply chains are compromised, substantial vaccine wastage occurs, limiting access to life-saving immunizations in many regions worldwide.
Özgür Tuncer, CEO & Executive Director of Stablepharma, stated: "This phase 1 clinical trial is an important step towards launching the world's first fridge-free Tetanus & Diphtheria vaccine (SPVX02) by 2027. We have shown that our StablevaX™ technology can be manufactured under commercially scalable GMP conditions, enabling us to scale-up the manufacturing process to provide millions of doses per year without the need for the global cold chain. Our ambition is to create a 'new era' in vaccines by reducing reliance on the cold chain."
Health and Social Care Secretary Wes Streeting highlighted the broader implications: "For years, vaccines have been held back by the need to be stored in a fridge – causing endless wastage and making it difficult to deliver them to remote communities. But thanks to this government's vision and our investment through the National Institute for Health and Care Research, all that could be about to change."
Expanding Applications and Recognition
Stablepharma's research and development team has identified approximately 60 temperature-sensitive vaccines that could benefit from the StablevaX™ technology. The company is actively forming partnerships with global vaccine manufacturers, academic institutions, and non-governmental organizations to accelerate the development of thermostable products.
Professor Jonathan Van-Tam, former Deputy Chief Medical Officer for England and member of the Stablepharma Advisory Board, noted: "If the shortcomings and complexities of the global cold chain in the distribution and storage of life-saving vaccines could be addressed through a proven fridge-free solution, such as the one being developed by Stablepharma, this would not only be revolutionary for the entire vaccine industry but also potentially lead to wider distribution and improved uptake in areas of the world where currently the stringency of the cold chain limits deployment and uptake."
The company's innovative approach has garnered significant recognition and support. Stablepharma was recently awarded a €2.5 million grant through the European Innovation Council (EIC) Accelerator program, acknowledging the excellence, impact potential, and risk management of their technology. Additionally, the company has received funding from shareholders and the UK Government, including Innovate UK and the NIHR.
Manufacturing and Future Outlook
A critical aspect of Stablepharma's technology is its compatibility with existing manufacturing processes. The StablevaX™ platform can be produced under scalable Good Manufacturing Practice (GMP) conditions, facilitating the production of millions of doses annually.
If successful, the SPVX02 vaccine is expected to launch by 2027, potentially transforming global vaccine distribution by reducing reliance on cold chain infrastructure, decreasing vaccine wastage, and improving access to immunizations in underserved regions.
Professor Faust, Director of the NIHR Southampton Clinical Research Facility, expressed optimism about the trial: "It is fantastic to see cutting-edge UK science reach the milestone of a first clinical trial and to be able to allow people living on the South Coast to take part. This research will be an important step toward exploring whether this innovation could eradicate vaccine wastage and move away from the need for the cold chain."
