A new type of universal coronavirus vaccine has passed its first human clinical trial, marking an important step toward broader protection against future virus outbreaks.
Developed by researchers at the University of Cambridge and the university spinout company DIOSynVax (DVX) Ltd, the experimental vaccine was found to be safe and caused no significant side effects in a study involving 39 healthy volunteers.
Unlike conventional vaccines that target specific virus strains, this vaccine was designed to protect against multiple members of the Sarbeco coronavirus family. This group includes SARS-CoV-2, the virus responsible for the COVID-19 pandemic, as well as SARS and several related bat coronaviruses that could potentially spill over into humans in the future.
The trial showed that the vaccine stimulated immune responses not only against SARS-CoV-2 and SARS, but also against related bat viruses that have not yet infected humans.
The findings were published in the Journal of Infection.
AI Designed Vaccine Technology
The study also marked another milestone. It was the first time a vaccine whose active ingredient was created entirely through computer simulations was tested in people.
Researchers used artificial intelligence and machine learning to design what they call a “super-antigen.” The antigen is the component of a vaccine that trains the immune system to recognize and fight infection.
Rather than focusing on a single virus strain, the AI system analyzed genetic information from Sarbeco coronaviruses collected through surveillance programs worldwide. Using this information, it identified features shared across the entire virus group and combined them into a single vaccine antigen.
The goal is to create protection not only against known viruses, but also against future strains that have not yet emerged.
“This trial proves the safety 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 — for example the Ebola group, or Sarbeco coronavirus group — even as they mutate.”
Researchers believe the same strategy could eventually be applied to other virus families, including Ebola viruses and influenza viruses.
Moving Beyond Constant Vaccine Updates
Many current vaccines, including seasonal flu shots and updated COVID-19 vaccines, are designed around virus strains already circulating in people. Because viruses evolve continuously, vaccines often need regular reformulation and annual updates.
Professor Jonathan Heeney from the Lab of Viral Zoonotics in the University of Cambridge’s Department of Veterinary Medicine, who led the scientific research, said the new approach could help solve that problem.
“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,” said Heeney.
He added: “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.”
By targeting features shared across an entire virus family, researchers hope the vaccine will remain effective even as new variants appear.
Human Clinical Trial Results
Volunteers between the ages of 18 and 50 received the vaccine at National Institute for Health and Care Research (NIHR) Clinical Research Facilities in Southampton and Cambridge.
The study was sponsored by University Hospital Southampton NHS Foundation Trust (UHSFT).
The vaccine’s super-antigen can be used with several different vaccine delivery platforms. In this trial, researchers delivered it as a DNA vaccine using a micro fluid jet system.
Because the method does not require a needle, it could offer an alternative for people who are uncomfortable with injections. Researchers also believe it may make large scale vaccination campaigns easier and faster, particularly in settings where traditional injections are more difficult to administer.
Before human testing began, animal studies showed the vaccine could generate strong immune responses against multiple coronaviruses.
The vaccine still requires additional testing before it could become available for public use. A larger Phase 2 study is planned to evaluate immune responses in a broader and more diverse group of participants and to confirm the vaccine’s ability to generate strong, wide ranging protection.
Preparing for Future Pandemic Threats
Scientists say the need for broader vaccine protection remains urgent because many potentially dangerous viruses continue to circulate in animals around the world.
“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,” said Professor Saul Faust from the University of Southampton, the trial’s chief investigator.
He added: “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.”
Professor Marian Knight, Scientific Director for NIHR Infrastructure, described the results as an important advance.
“The remarkable success of this AI-designed ‘super-antigen’ trial marks a pivotal leap forward in our ability to deliver broad, lasting viral protection.”
She added: “This milestone was only made possible through partnerships between the life sciences sector and our world-class NIHR infrastructure in Cambridge and Southampton, whose Clinical Research Facilities provided the vital expertise and environment needed to safely fast-track this innovation, and bring it one big step closer to patients.”
Researchers note that SARS-CoV-2 and other Sarbeco coronaviruses remain public health concerns. At the same time, many other viruses continue to circulate in animals and could potentially cross into humans, although it is impossible to predict which virus might emerge next or when.
The project was funded primarily by Innovate UK.
DIOSynVax, short for Digitally Immune Optimised Synthetic Vaccines, was founded in 2017 as a University of Cambridge spinout with support from Cambridge Enterprise, the university’s commercialization arm.
The company’s vaccine development pipeline also includes candidates targeting seasonal influenza, pandemic influenza threats, hemorrhagic fever viruses, and coronaviruses including SARS-CoV-2.
Jonathan Heeney is Professor of Comparative Pathology at the University of Cambridge and a Fellow of Darwin College.
