London, UK – 03 November 2025 – Stablepharma announced the database lock of its Phase 1 clinical trial of the world’s first, fridge-free, tetanus-diphtheria vaccine, SPVX02, which began recruitment in April this year.
The trial evaluated the safety, tolerability and immunogenicity of SPVX02 against 2 comparator vaccines and enrolled 60 healthy participants at 2 UK sites, NIHR Southampton Clinical Research Facility and the Medicines Evaluation Unit in Manchester, under the supervision of study Chief Investigator Professor Saul Faust.
The trial will be deemed a success if both of the primary endpoints relating to safety and tolerability are met, however the secondary endpoints relating to immunogenicity will also be evaluated.
The Stablepharma team remain focussed on the trial close out activities and are delighted that the data analysis by our selected, independent statisticians has started , we look forward to reporting top-line results from the phase trial.
“Achieving database lock is a critical step on our path to delivering a new generation of thermostable vaccines that can remove the need for cold-chain storage worldwide and reduce unnecessary cost and wastage,” said Ozgur Tuncer, CEO & Executive Director, Stablepharma. “We’re proud of our team’s scientific and operational excellence, led by Dr Karen O’Hanlon, Chief Development Officer, and Juana de la Torre Arrieta, Development Project Manager, who made this possible.”
Stablepharma’s proprietary technology platform, StablevaX™, reformulates existing and new vaccines and pharmaceutical products into thermostable products that are completely stable at temperatures 40°C and above, and do not require cold storage such as refrigeration or freezing.
A full set of results from the clinical trial will be published in a scientific paper in due course and the development team are already preparing for the pivotal, confirmatory Phase 2/3 clinical trial.
“Our team is delighted to have reached database lock for the proof-of-concept Phase 1 trial and we are excited to take our fridge-free tetanus and diphtheria vaccine into a confirmatory Phase 2/3 pivotal trial”, said Dr Karen O’Hanlon. “This randomised, single-blind, non-inferiority trial will involve a larger number of healthy participants, split equally into 2 cohorts (one for SPVX02 and one for an established Td vaccine already licensed in Europe). The study will be managed by PPD, a Thermo Fisher Scientific company, and conducted across approximately 10 sites in the UK and Spain”.
“Our technology enables significantly shorter development timelines,” said Ozgur Tuncer. “By reformulating existing vaccines, StablevaX™ reduces R&D cycles compared to developing entirely new thermostable vaccines. Because the core adjuvants and antigens remain unchanged and the CMC process is GMP validated, regulatory pathways are streamlined — allowing fridge-free vaccines to reach the market faster, more efficiently, and at lower cost. We are very excited about the future.”
Stablepharma Ltd is advancing its pioneering thermostable vaccine technology and this phase 1 clinical trial was funded by the Innovate UK Smart Grant programme from the UK government. Stablepharma gratefully acknowledge the support of Innovate UK, part of UK Research and Innovation (UKRI), for enabling the development and commercial advancement of their thermostable vaccine platform, SPVX02.
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