A world‑first trial of a fridge‑free tetanus‑diphtheria vaccine has delivered encouraging phase 1 results, raising hopes of expanding access to life‑saving immunisation in remote regions while reducing carbon emissions.
Around half of vaccines are wasted globally each year due to temperature‑related failures in storage and transport.
The reformulated vaccine, SPVX02, developed by UK biotech Stablepharma using its StablevaX technology, remained stable for at least two years at temperatures up to 30°C and retained full potency after repeated extreme temperature fluctuations between -20°C and +40°C. Results have been published in eClinicalMedicine.
The study, conducted at the NIHR Clinical Research Facility in Southampton and supported by the NIHR Biomedical Research Centre, enrolled 60 healthy adults.
By day 28, all participants receiving SPVX02 achieved protective antibody levels comparable to licensed vaccines, with no vaccine‑related serious adverse events reported.
Professor Saul Faust, who led the study, 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.”
He added: “If larger studies confirm these findings, this technology could help transform the way vaccines are stored and delivered around the world.”
Özgür Tuncer, Stablepharma CEO, explained: “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.”
Dr Bruce Roser, Stablepharma founder, 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.”
A phase 2b trial is now under way to evaluate SPVX02 in a larger population.
