The first patient has been dosed in a Phase I trial of Stablepharma’s tetanus-diphtheria vaccine, which does not need to be refrigerated.
The vaccine candidate, SPVX02, is completely stable at room temperature, and in testing was fully potent after three cycles of extreme temperature fluctuations ranging from -20°C to 40°C. The candidate has been developed to withstand these temperatures through the company’s StablevaX technology.
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In what is being branded a “world-first”, the first patient in the trial of SPVX02 was dosed earlier this month at a National Health Service (NHS) site in the UK. The vaccine doses of SPVX02 being used in the Phase I study also have an 18-month shelf life.
The trial, backed by the UK Government, including Innovate UK and the National Institute for Health and Care Research (NIHR), is expected to be completed by the end of Q3 2025, with data set to be published before the end of 2025.
Stablepharma’s chief development officer Dr Karen O’Hanlon said: “Our team have worked tirelessly to reach the start of this Phase I 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 tetanus and diphtheria vaccine, a groundbreaking innovation in vaccine technology.”
According to the World Health Organization (WHO), approximately 50% of all vaccines are wasted around the world each year due to cold chain failures. While most vaccines need constant refrigeration between 2°C and 8°C, some biologics require storage at -20°C, highlighting the importance of room-temperature stabilisation.
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By GlobalDataUK-based Stablepharma anticipates a commercial launch of SPVX02 as early as 2027.
The company has identified up to 60 temperature-sensitive vaccines that it believes could be suitable for its StablevaX technology platform to reformulate them into thermostable products that do not require cold chain storage.
In February 2025, Stablepharma was one of five UK companies awarded a $2.85m (€2.5m) grant through the European Innovation Council (EIC) Accelerator programme. This came after the company received €50,000 through the Horizon Europe Scheme in February 2021.
