UK scientists complete first human trial of fridge-free tetanus and diphtheria vaccine

UK scientists have successfully completed the first human trial of a reformulated tetanus and diphtheria vaccine that can be stored at room temperature, potentially transforming vaccine delivery in countries where refrigeration is limited.

The vaccine, known as SPVX02, has been developed using a technology that enables it to remain stable without the need for the continuous refrigerated “cold chain” required by most vaccines. Researchers say the approach could reduce vaccine wastage, lower costs and improve access to life-saving immunisations worldwide.

Phase I clinical trial results showed the vaccine was safe, well tolerated and generated immune responses comparable with existing refrigerated tetanus and diphtheria vaccines. The study, involving 60 healthy adults, found no vaccine-related serious adverse events, with all participants who received SPVX02 achieving protective antibody levels against both diseases by 28 days after vaccination.

Scientists from the UK Health Security Agency (UKHSA) supported the study through specialist laboratory testing at its Vaccine Development and Evaluation Centre. Ongoing stability studies indicate the vaccine remains potent after at least 24 months when stored at 30°C, eliminating the need for refrigeration during transport and storage.

The World Health Organization estimates that up to half of all vaccines are wasted globally, with failures in the cold chain being a major contributing factor. Researchers believe thermostable vaccines such as SPVX02 could improve immunisation programmes, particularly in low- and middle-income countries, remote communities and humanitarian emergencies where maintaining refrigeration is challenging.

Following the successful completion of the Phase I study, SPVX02 will now progress to larger clinical trials to further evaluate its effectiveness against licensed tetanus and diphtheria vaccines before regulatory approval is considered.

Stay informed with the stories shaping health and social care.

Register with The Daily Round for the latest sector news, inspections & reports, wellbeing content, workforce insights, expert features and practical updates—delivered free to your inbox.