Fridge-free tetanus-diphtheria vaccine shows promise of reaching millions worldwide
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The encouraging results of the world's first trial of a fridge-free tetanus-diphtheria vaccine could improve access worldwide to crucial treatments while reducing carbon emissions. Fridge-free vaccines have the potential to transform vaccine delivery by reducing dependence on refrigeration. This would improve access in more isolated communities and cut the environmental impact by reducing energy use and emissions.
Around half of vaccines are wasted globally each year, according to the World Health Organization. Millions of doses are lost because of temperature changes during storage and transport.
This phase I study, led by the University of Southampton and University Hospital Southampton NHS Foundation Trust, found the vaccine was well tolerated, with no vaccine-related serious adverse events. The results are published in the journal eClinicalMedicine.
Saul Faust, professor of pediatric immunology and infectious diseases at the University of Southampton and director of the NIHR Clinical Research Facility in Southampton, who led the study, said, "Keeping vaccines cold from the factory to the patient is one of the biggest challenges facing immunization programs worldwide. Our study suggests that this vaccine can remain safe and effective without refrigeration.
"If larger studies confirm these findings, this technology could help transform the way vaccines are stored and delivered around the world."
The trial
The trial took place in the National Institute for Health and Care Research (NIHR) Clinical Research Facility at University Hospital Southampton and was delivered through the NIHR Biomedical Research Center: Southampton. The reformulated vaccine, known as SPVX02, was developed by U.K.-based biotech company Stablepharma using its StablevaX technology.
The research shows that SPVX02 can be stored at temperatures of up to 30°C (86°F) for at least two years without losing its effectiveness. Scientists are now investigating whether it can remain stable for as long as four years.
Researchers have also demonstrated that the vaccine remains stable and fully potent after three cycles of extreme temperature fluctuation from -20°C (-4°F) to +40°C (104°F).
The randomized trial, which also involved the Medicines Evaluation Unit (MEU) in Manchester, enrolled 60 healthy adults.
By 28 days after vaccination, all participants receiving SPVX02 achieved protective antibody levels against both tetanus and diphtheria, demonstrating immune responses comparable to licensed vaccines.
Next steps
The eClinicalMedicine publication follows the launch of a phase 2b trial that will further assess the vaccine in a larger group of participants.
Stablepharma's technology platform, StablevaX, can be applied to vaccines, small molecules, peptides and biologics. It is currently working with a partner to thermostabilize small-molecule oncology and anti-infective products, in addition to other vaccines.
Özgür Tuncer, Stablepharma CEO and executive director, said, "This peer-reviewed validation represents a pivotal moment for our StablevaX platform and the future of thermostable vaccines. These findings strengthen the scientific and global health case for a new generation of fridge-free vaccines, particularly in regions where cold-chain limitations hinder equitable access."
Health and Social Care Minister Diana Johnson said, "This pioneering research demonstrates how British innovation is helping to tackle some of the biggest challenges in global health care and providing lifesaving breakthroughs for use around the world.
"Right now, people are dying of preventable diseases all over the world, not due to a lack of vaccines but a lack of refrigeration. Fridge-free vaccines have the potential to be a game-changer for global health, especially for people in remote communities or regions affected by conflict.
"Backed by NIHR's world-leading research, this breakthrough shows once again how our investment in science and life sciences is driving better health outcomes while supporting economic growth and reinforcing the U.K.'s position at the forefront of medical innovation."
Publication details
Thomas A.N. Reed et al, Safety, tolerability, and immunogenicity of SPVX02, a room temperature-stabilised tetanus-diphtheria vaccine, compared to two established tetanus-diphtheria booster vaccines: a multicentre, single-blind, randomised, first-in-human phase 1 trial in the UK, eClinicalMedicine (2026). DOI: 10.1016/j.eclinm.2026.104116
Journal information: EClinicalMedicine
Clinical categories
Infectious diseasesPreventive medicineCommon illnesses & Prevention Provided by University of Southampton Who's behind this story?
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