The results of a world-first clinical trial for a fridge-free vaccine have today been announced, potentially improving access to vital treatments globally.
The revolutionary tetanus-diphtheria vaccine, known as SPVX02, underwent testing as part of a first in human trial (phase 1) which was given HRA Approval in February 2025.
Developed by UK-based biotech company Stablepharma, the clinical 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 Centre: Southampton.
Trial results show that the vaccine can be stored at temperatures of up to 30°C for at least 2 years without losing its effectiveness. This could transform vaccine delivery, leading to more people being able to access vaccines, especially those in isolated regions, while also reducing carbon emissions.
Stablepharma has now launched a phase 2b trial that will further assess the vaccine in a larger group of participants. This study was given HRA Approval in June 2026.
As part of the approvals process, the initial phase 1 trial application was reviewed by members of London Bridge Research Ethics Committee (REC) and the phase 2b trial was reviewed by members of West London Gene Therapy Advisory Committee REC.
RECs are committees that are independent of the research team, the sponsor and the funders of the research. They are made up of volunteer members from a range of backgrounds, and review research applications to make sure they are ethical and safe for the people taking part in the study.
Every health and social care research study reviewed through our processes undergoes careful, robust scrutiny before a decision is made about whether it should go ahead.
Dr Jonathan Fennelly-Barnwell, Interim Director of Approvals at the Health Research Authority"The results of this clinical trial and the subsequent phase 2b study could lead to potentially huge changes for how millions of people across the globe access life-saving vaccines and other treatments.
"It's great to see ground-breaking trials like this one take place in the UK and demonstrates how our clinical research system is attracting world-first, innovative health and social care research that has the potential to transform people's lives.
"We're very proud of the role we're playing in helping to make the UK the best place in the world for health research, and I'd like to pay special thanks to the work of our staff and our RECs for all the vital work they do to support our health and social care research regulatory system."