A new universal coronavirus vaccine has passed its first human clinical trial, an important step towards widespread protection against future virus outbreaks.
An experimental vaccine developed by Cambridge University researchers and university spin-out company DIOSynVax (DVX) Ltd was found to be safe and cause no serious side effects in a study of 39 healthy volunteers.
Unlike traditional vaccines that target specific virus strains, this vaccine is designed to protect against multiple members of the sarbecocoronavirus family. This group includes SARS-CoV-2, the virus that causes the COVID-19 pandemic, as well as SARS and several related bat coronaviruses that could potentially infect humans in the future.
The trial showed that the vaccine stimulated an immune response not only to SARS-CoV-2, or SARS, but also to related bat viruses that have not yet infected humans.
The survey results are infection journal.
AI-designed vaccine technology
The study also marked a new milestone. It was the first time a vaccine whose active ingredients were created entirely by computer simulation was tested in humans.
Researchers used artificial intelligence and machine learning to design what they called “superantigens.” Antigens are the components of vaccines that train the immune system to recognize and fight infections.
Rather than focusing on a single virus strain, the AI system analyzed the genetic information of Sarbeco coronavirus collected through surveillance programs around the world. They used this information to identify common features across virus groups and combined them into a single vaccine antigen.
The goal is to create protection not only against known viruses, but also against future viruses that have not yet emerged.
“This trial demonstrates the safety of a completely new method of vaccine design. This technology uses AI-designed ‘superantigens’ to provide durable protection against a wide range of viruses even if they mutate, such as the Ebola group and the Sarvecocoronavirus group.”
Researchers believe the same strategy could eventually be applied to other virus families, such as Ebola and influenza viruses.
Beyond continued vaccine updates
Many current vaccines, including seasonal influenza shots and the latest coronavirus disease (COVID-19) vaccines, are designed around strains of viruses that are already circulating in the population. As viruses continually evolve, vaccines often require periodic reformulation and annual updates.
Professor Jonathan Heaney, from the Laboratory of Viral Zoonosis at the University of Cambridge’s School of Veterinary Medicine, who led the scientific study, said a new approach could help solve that problem.
“We have shifted vaccine development from being reactive to being proactive. Our vaccines continue to protect even as the virus mutates into new strains,” Heaney said.
He added: “We have overcome the problem of traditional vaccines with limited protection. This means we can escape the constant cycle of chasing viral variants circulating in humans, like a dog chasing its tail, and updating vaccines to keep up.”
Researchers hope that by targeting common traits across virus families, the vaccine will remain effective even as new variants emerge.
Human clinical trial results
Volunteers aged between 18 and 50 were vaccinated at National Institute for Health Research (NIHR) clinical research sites in Southampton and Cambridge.
This research was sponsored by Southampton University Hospitals NHS Foundation Trust (UHSFT).
Vaccine superantigens can be used in several different vaccine delivery platforms. In this trial, the researchers administered it as a DNA vaccine using a microfluidic jet system.
This method does not require a needle, so it could be an alternative for people who don’t like injections. Researchers also think it could make mass vaccination campaigns easier and faster, especially in settings where traditional shots are difficult to administer.
Before human trials began, animal studies showed the vaccine could generate strong immune responses against multiple coronaviruses.
Additional testing is still needed before the vaccine is available for general use. Larger phase 2 trials are planned to assess immune responses in a broader and more diverse group of participants and confirm the vaccine’s ability to produce strong and broad-based protection.
Prepare for future pandemic threats
Scientists say the need for widespread vaccine protection remains urgent as many potentially dangerous viruses continue to circulate among animals around the world.
Professor Saul Faust from the University of Southampton, lead researcher on the trial, said: “Viruses such as influenza, coronaviruses and Ebola are continually evolving, and by the time a vaccine is rolled out they may be poorly suited. Current ‘reactive’ vaccine systems are struggling to keep up with that pace.”
He added: “This new class of universal vaccines is future-proofed. It has the potential to protect not only against many variants at once, but also from related viruses that have not yet emerged and are circulating in humans.”
“If we can develop and clinically advance this new class of vaccines before the virus outbreak begins, we have the potential to save millions of lives, avoid lockdowns, and keep the economy afloat.”
NIHR Infrastructure Science Director Professor Marian Knight said the results were an important advance.
“The remarkable success of this AI-designed ‘superantigen’ test represents a pivotal advance in our ability to provide broad and sustained viral protection.”
He added: “This milestone has only been made possible through our partnership with the life sciences sector and the world-class NIHR infrastructure in Cambridge and Southampton. Its clinical research facilities have provided the critical expertise and environment needed to bring this innovation forward safely, quickly and to bring a major step forward for patients.”
Researchers note that SARS-CoV-2 and other sarbecocoronaviruses remain a public health concern. At the same time, many other viruses continue to circulate among animals and can potentially infect humans, but it is impossible to predict which virus will emerge next and when.
This project was primarily funded by Innovate UK.
DIOSynVax (short for Digital Immune Optimized Synthetic Vaccines) was established in 2017 as a spin-out of the University of Cambridge, 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 Heaney is Professor of Comparative Pathology at the University of Cambridge and Fellow of the University of Darwin.
