A groundbreaking vaccine which could help reach millions without the need for refrigeration has been tested successfully.
Researchers at University Hospital Southampton, with the Medicines Evaluation Unit (MEU) in Manchester, ran the world’s first clinical trial of a fridge-free tetanus-diphtheria vaccine, which uses UK-developed technology to remain stable at room temperature.
The study, published in The Lancet’s eClinicalMedicine, found the vaccine to be safe, well-tolerated, and as effective as current refrigerated vaccines.
Professor Saul Faust, director of the NIHR Clinical Research Facility in Southampton, said: "Keeping vaccines cold from the factory to the patient is one of the biggest challenges facing immunisation programmes worldwide.
"Our study suggests that this vaccine can remain safe and effective without refrigeration.
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"If larger studies confirm these findings, this technology could help transform the way vaccines are stored and delivered around the world."
Developed by British biotech company Stablepharma, the vaccine, known as SPVX02, uses the company’s StablevaX technology to remain effective at temperatures up to 30C for at least two years.
Researchers are now exploring whether it could remain stable for up to four years.
The phase one trial, delivered through the NIHR Biomedical Research Centre in Southampton, enrolled 60 healthy adults.
All participants who received SPVX02 developed protective antibody levels against both tetanus and diphtheria within 28 days, with immune responses matching those of licensed vaccines.
The findings arrive as a phase 2b trial gets underway.
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Fridge-free vaccines could prove critical in improving access to immunisation in remote or low-resource areas where cold storage isn’t reliable.
The World Health Organization estimates that around half of vaccines are wasted each year, often because of temperature-related issues during storage and transport.
Stablepharma plans to complete the clinical development of SPVX02 by 2027.
Dr Bruce Roser MB BS, PhD, founder and board member of Stablepharma, said: "Reliable and safe fridge-free vaccines could be a game changer for global health – helping life-saving vaccines reach millions more people, wherever they live, and making immunisation programmes more sustainable, reliable and equitable for future generations."
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