A clinical trial testing a fridge-free tetanus and diphtheria vaccine has shown ‘encouraging’ early results and has progressed to the next stage, the National Institute of Health and Care Research (NIHR) has confirmed.
The phase I study, which completed in March, shows the SPVX02 vaccine remains effective without refrigeration even after long-term storage at 30°C for two years.
Results published in The Lancet group’s eClinicalMedicine, showed the vaccine was well tolerated, with no vaccine-related serious adverse events.
The study, which sets out to test the thermostable, fridge-free tetanus and diphtheria vaccine, was conducted at UK Health Security Agency’s (UKHSA) Vaccine Development and Evaluation Centre (VDEC), and was done in collaboration with Stablepharma Ltd.
It is hoped that fridge-free vaccines could improve access worldwide to crucial treatments, while reducing carbon emissions.
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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, 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 suggested that if larger studies supported the findings, ‘this technology could help transform the way vaccines are stored and delivered around the world’.
The randomised trial, which also involved the Medicines Evaluation Unit (MEU) in Manchester, enrolled 60 healthy adults.
By 28 days after vaccination, all participants receiving the SPVX02 achieved protective antibody levels against both tetanus and diphtheria, demonstrating immune responses comparable to licensed vaccines.
While showing the vaccine can be stored at temperatures of up to 30°C for at least two years without losing its effectiveness, researchers have also demonstrated that the vaccine remains ‘stable, and fully potent’, after three cycles of extreme temperature fluctuation from -20°C to +40°C.
Scientists are now investigating whether it can remain stable at temperatures of up to 30°C for as long as four years.
And a phase 2b trial has been launched to further assess the vaccine in a larger group of participants.
According to the World Health Organization (WHO), around half of vaccines are wasted globally each year due to temperature changes during storage and transport.
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The NIHR states that fridge-free vaccines have the potential to ‘transform vaccine delivery’ by reducing dependence on refrigeration, in turn improving access to more isolated communities and cut the environmental impact by reducing vast amounts of energy that lead to emissions.
Health and social care minister Dame Diana Johnson has praised the research, describing it as a ‘life-saving breakthrough’.
‘Right now, people are dying of preventable diseases all over the world, not due to a lack of vaccines, but a lack of refrigeration,’ she said.
‘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 UK’s position at the forefront of medical innovation.’
Chief scientific adviser at the Department of Health and Social Care (DHSC) and chief executive officer of the NIHR Professor Lucy Chappell, added: ‘Vaccines save lives, but only if they can reach the people who need them.
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‘Removing the need for refrigeration could be transformative for communities around the world.
‘This is a great example of UK research once again leading the way to bring life-saving treatments to people where they are, making health equity a reality.’
