World-first trial launched for fridge-free vaccine
An innovative vaccine that doesn’t need to be refrigerated or frozen has entered its first clinical trial at University Hospital Southampton.
The Stablepharma tetanus-diphtheria vaccine (SPVX02) is completely stable at room temperature. It has been designed to greatly expand access worldwide.
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 in the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility. The facility is located at Southampton General Hospital.
The first participant is entering the trial this month.
Tetanus and diphtheria are serious infectious diseases. Vaccination helps protect against them.
However, about half of all vaccines are wasted around the world each year. This is according to data from the World Health Organization.
Access to vaccines is limited by the international, temperature-controlled supply chain (cold chain).
This cold chain is complex and costly. It requires vast amounts of energy that lead to carbon emissions. It can also lead to significant vaccine wastage when the cold chain is compromised.
UK-based biotech company Stablepharma has developed a novel technology. They have had support from a UK government-backed programme.
Stablepharma’s platform converts existing approved vaccines to fridge-free versions. These are ‘thermostable’. They can be stored for long periods of time at room temperature.
SPVX02 is the lead candidate fridge-free tetanus and diphtheria vaccine. It is now 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 is the Director of the NIHR Southampton Clinical Research Facility. He 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. Results will be 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. The agency is 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 (NIHR), 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 worldwide helping deliver vaccines to poorer nations, where they’re often needed the most. Firmly positioning the UK a pioneer life science, and a driver in global development.
“The Prime Minister is transforming our economy through our Plan for Change. Projects like this are vital in driving growth and firmly positioning the UK as a global leader in vaccine development and research.”
Professor Lucy Chappell is NIHR Chief Executive and Chief Scientific Adviser at the Department for Health and Social Care. Professor Chappell 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. It 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, is a member of the Stablepharma Advisory Board. Professor Van-Tam 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 be revolutionary for the entire vaccine industry. It could 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.”
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).
The batch in the current phase I study has a shelf life of 18 months. This has been agreed by the Medicines and Healthcare products Regulatory Agency.
The team have also shown that SPVX02 can withstand temperature fluctuation. It remained stable and fully potent after three cycles of extreme fluctuation from -20℃ to +40℃.
These studies highlight the robustness of Stablepharma’s technology platform, StablevaX™. They provide compelling evidence of its unique ability to thermostablise vaccines.
Stablepharma was also recently awarded a €2.5 million grant. It is from the prestigious European Innovation Council (EIC) Accelerator programme.
The company has identified up to 60 vaccines that could be suitable for StablevaX™ technology.
Contact CRFstudyteam@uhs.nhs.uk or call 023 8120 4989 for further details on how to take part in the new trial.