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An innovative vaccine that doesn’t need to be refrigerated or frozen has entered its first clinical trial.
The Stablepharma tetanus-diphtheria vaccine (SPVX02) is completely stable at room temperature and has been designed to greatly expand access worldwide. If successful, the trial would deliver a huge boost to the UK’s life sciences sector, helping to maintain its position as a world-leading force in health research.
The vaccine development has now reached the stage where it is ready to be trialled through a UK government-backed programme. The first-in-human trial is taking place at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility at University Hospital Southampton.
Around half of vaccines are wasted globally each year, according to the World Health Organization.
One of the biggest barriers that limit access to vaccines is the international, temperature-controlled supply chain (cold chain).
This cold chain is complex, costly and requires vast amounts of energy that lead to carbon emissions. It also leads to significant amounts of vaccine wastage when the cold chain is compromised.
UK-based biotech company Stablepharma has developed a novel technology with support from a UK government-backed programme. Their platform converts existing approved vaccines to fridge-free versions that are ‘thermostable’ and can be stored for long periods of time at room temperature.
The lead candidate fridge-free tetanus and diphtheria vaccine, SPVX02, has now reached the stage where it is being trialled solely through NIHR-funded infrastructure.
The clinical trial is being led by Professor Saul Faust from the University of Southampton and Stablepharma chief development officer Dr Karen O’Hanlon.
Professor Faust, Director of the NIHR Southampton Clinical Research Facility, said: “It is fantastic to see cutting-edge UK science reach the milestone of a first clinical trial and to be able to give the opportunity for 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.”
Dr O’Hanlon added: “We are delighted to have received funding from a UK government scheme and support from NIHR for our first clinical trial. This is an important milestone towards launching the world’s first fridge-free tetanus-diphtheria vaccine.
“We have also previously demonstrated that our technology can be manufactured under commercially scalable GMP conditions, enabling a scaling-up to millions of doses per year without the need for the global cold chain.”
The phase I clinical trial is expected to complete in summer 2025, with results published by the end of the year. The research is being delivered within the NIHR Southampton Biomedical Research Centre. Early phase clinical trials are important first steps to testing treatments in people. They examine the safety, side effects, best dose and timing of new treatments.
Stablepharma hope the vaccine will be in use globally by 2027.
The SPVX02 vaccine has been developed with support from Innovate UK, part of UK Research and Innovation (UKRI).
Health and Social Care Secretary Wes Streeting said: “For years, vaccines have been held back by the need to be stored in a fridge – causing endless amounts of 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.
“We are leading the charge by pushing through the world’s first trial for fridge free vaccines. This could be a real game changer and lifesaver globally – as it unlocks new ways for poorer nations to deliver vaccines to their patients, where they’re often needed the most.
“Groundbreaking science is amongst the things that Britain does best, and this innovation reaffirms our position as a world leader in vaccine development and research, boosting growth and economic security – the cornerstone of our Plan for Change.”
Professor Lucy Chappell, NIHR chief executive, and chief scientific adviser at the Department for Health and Social Care, said: “This clinical trial represents a crucial step in building the evidence for this game-changing development in vaccine delivery. The NIHR is proud to be supporting this work through its world-leading research infrastructure, which provides industry partners such as Stablepharma with the support necessary to deliver cutting edge research here in the UK that could lead to better health outcomes around the world.”
Professor Jonathan Van-Tam, former deputy chief medical officer for England and member of the Stablepharma Advisory Board, said: “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.
“Fridge-free vaccines could, in the future, play a major role in delivering the WHO's ambitions for universal health coverage (UHC).”
Scientists at Stablepharma have previously demonstrated that the SPVX02 vaccine remains completely stable for at least 12 months at 30°C and 40°C (climate zone IVB). A shelf life of 18 months has been agreed with MHRA for the current clinical batch prepared for the phase I study.
The team have also successfully demonstrated that SPVX02 remains stable, and fully potent, after three cycles of extreme temperature fluctuation from -20°C to +40°C.
Taken together, these studies highlight the robustness of Stablepharma’s technology platform, StablevaX, and provides yet further compelling evidence of its unique ability to thermostablise vaccines.
Stablepharma was recently awarded €2.5 million through the prestigious European Innovation Council (EIC) Accelerator program. The grant recognises the company’s cutting-edge fridge-free pharmaceutical technology, which meets EIC’s rigorous criteria for excellence, impact, and risk management.
The company has identified up to 60 vaccine candidates that could be suitable for StablevaX technology.
The NIHR Clinical Research Facility (CRF) in Southampton is one of 28 NIHR CRFs dedicated to early phase, experimental medicine and high-risk studies.
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