The first clinical trial of a ‘universal’ Sarbeco coronavirus vaccine at two National Institute for Health and Care Research (NIHR) facilities has shown that the vaccine is safe and has no significant side effects.
This trial proves the effectiveness of an entirely new way of designing vaccines. The technology uses an AI-designed ‘super-antigen’ to provide lasting protection against a broad range of viruses even as they mutate.
The study took place at the NIHR Southampton Clinical Research Facility and the NIHR Cambridge Clinical Research Facility. It was sponsored by University Hospital Southampton NHS Foundation Trust and recruitment was supported by the NIHR Research Delivery Network.
The innovation has been developed by the University of Cambridge and spin-out company DIOSynVax.
The trial, involving 39 healthy volunteers, tested a vaccine designed to provide protection against multiple Sarbeco coronaviruses - the large group of viruses that occur in nature including SARS-CoV-2, which caused the COVID-19 pandemic.
The vaccine triggered immune responses in the volunteers not only to SARS-CoV-2 and SARS, but to related bat viruses that could potentially jump from animals to humans and cause future pandemics. This is the first time that a vaccine whose active component was designed entirely by computer simulations has been tested in humans.
The results have been published in Journal of Infection.
Professor Jonathan Heeney from the Lab of Viral Zoonotics, University of Cambridge’s Department of Veterinary Medicine, is the scientific lead of the research. He said: “We’ve converted vaccine development from being reactive to being future proof. Our vaccines will continue to provide protection against viruses even as they mutate into new strains. We’ve overcome the problem of traditional vaccines, which have limited protection. It means we can escape the constant cycle of chasing the virus variants circulating in humans and updating the vaccines to try to catch up, like a dog chasing its tail.”
To design the antigen for a universal coronavirus vaccine, the team used all the available genetic sequence data for Sarbeco coronaviruses logged by surveillance programmes around the world. Using machine learning, they then designed a superantigen that contains the antigen features common to this entire group of viruses – including those that haven’t emerged yet.
Professor Saul Faust, chief investigator of the trial and director of the NIHR Southampton Clinical Research Facility, said: “Viruses like influenza, coronaviruses and the ebola group are evolving continuously and by the time vaccines are rolled out, they may be poorly matched - the current ‘reactive’ vaccine system struggles to keep pace. This new class of universal vaccines are future-proofed. They not only protect against many variants simultaneously, but potentially against related viruses that haven’t yet emerged and spilt over to humans. If we can develop and clinically advance this new class of vaccines before a virus outbreak begins, millions of lives could be saved, lockdowns avoided and the economy preserved.”
The super antigen is compatible with most vaccine delivery systems. In this trial, it was administered as DNA vaccine through a microfluidic jet. This needle-free delivery method offers an alternative to those with a fear of needle-based injections. This could make vaccination faster and easier to carry out in large numbers of people, especially in settings where conventional injections are more challenging to deliver.
Further development of the vaccine is needed before it is ready for public use. A larger Phase 2 trial will next assess the vaccine’s ability to induce immune responses in a wider and more diverse population, and confirm that it generates strong, broadly protective immune responses.
The research was primarily funded by Innovate UK. The DIOSynVax pipeline includes vaccine candidates for human seasonal flu and the pandemic influenza threats, haemorrhagic fever viruses, and coronaviruses including SARS-CoV-2.
- Munro AP, Ferrari M, Kinsley R, et al. A phase I, needle free, dose escalation clinical trial of pEVAC-PS, a candidate pan-Sarbecovirus Vaccine. J Infect. 2026;92(6):106759. doi:10.1016/j.jinf.2026.106759