A fridge-free tetanus and diphtheria vaccine has advanced to phase 2b clinical trials after a phase I study confirmed the SPVX02 formula remains stable and effective without cold-chain storage for up to two years at 30°C, according to the National Institute of Health and Care Research (NIHR). The trial, which completed in March, tested the thermostable vaccine on 60 healthy adults at the UK Health Security Agency’s (UKHSA) Vaccine Development and Evaluation Centre (VDEC) in collaboration with Stablepharma Ltd.
Phase I Trial Results and Immune Response
All 60 participants enrolled in the randomised trial achieved protective antibody levels against both tetanus and diphtheria by 28 days after receiving the SPVX02 vaccine, according to published results in The Lancet group’s eClinicalMedicine. The study, which also involved the Medicines Evaluation Unit (MEU) in Manchester, demonstrated that the vaccine was well tolerated with no vaccine-related serious adverse events reported.
Beyond normal storage testing at 30°C for two years, researchers demonstrated that the vaccine stayed stable and fully potent after enduring three cycles of extreme temperature fluctuations ranging from -20°C to +40°C. Scientists are now investigating whether the formula can maintain stability at 30°C for up to four years, and a phase 2b trial has been launched to evaluate the vaccine in a larger participant group.
Global Health Implications of Cold-Chain Elimination
According to the World Health Organization (WHO), approximately half of all vaccines are wasted globally each year due to temperature fluctuations during storage and transport. Professor Saul Faust, director of the NIHR Clinical Research Facility in Southampton and Professor of Paediatric Immunology and Infectious Diseases at the University of Southampton, who led the study, stated that keeping vaccines cold from the factory to the patient is one of the biggest challenges facing global immunisation programmes.
Health and social care minister Dame Diana Johnson described the research as a life-saving breakthrough, noting that preventable deaths often occur due to a lack of refrigeration rather than a lack of the vaccines themselves. Department of Health and Social Care (DHSC) chief scientific adviser and NIHR chief executive officer Professor Lucy Chappell added that removing the need for refrigeration could transform communities and make health equity a reality.
Did you know?
According to the NIHR, eliminating dependence on refrigeration for vaccine transport not only improves access for isolated communities, but also cuts environmental emissions by reducing the vast amounts of energy currently required for cold-chain logistics.
Frequently Asked Questions
What is the SPVX02 vaccine?
SPVX02 is a thermostable tetanus and diphtheria vaccine designed to remain effective without refrigeration.
Which organisations conducted the trial?
The phase I study was conducted at the UK Health Security Agency’s Vaccine Development and Evaluation Centre (VDEC) in collaboration with Stablepharma Ltd, involving the Medicines Evaluation Unit in Manchester.
What stage is the vaccine development in now?
Following successful phase I results published in eClinicalMedicine, a phase 2b trial has been launched to assess the vaccine in a larger group of participants.
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