Clinical researchers are this week set to begin human trials of a new coronavirus vaccine developed by researchers at Imperial College London. The study will be the first time the vaccine has been trialled in humans and will test whether it is well-tolerated and produces an effective immune response against COVID-19.
Imperial’s vaccine candidate will be the first test of a new self-amplifying RNA technology, which has the potential to revolutionise vaccine development and enable scientists to respond more quickly to emerging diseases. The vaccine has undergone rigorous pre-clinical safety tests and in animal studies it has been shown to be safe and produced encouraging signs of an effective immune response.
Over the coming weeks, 300 healthy participants will receive two doses of the vaccine. If the vaccine is safe and shows a promising immune response in humans, then larger Phase III trials would be planned to begin later in the year with around 6000 healthy volunteers to test its effectiveness.
Ultimately, the researchers hope that if clinical trials are successful, the vaccine could provide protection against COVID-19 both in the UK and around the world.
Professor Robin Shattock, from the department of infectious disease at Imperial and who is leading the work, said: “The COVID-19 pandemic has claimed thousands of lives and had a huge impact on daily life. In the long-term, a viable vaccine could be vital for protecting the most vulnerable, enabling restrictions to be eased and helping people to get back to normal life.
“From a scientific perspective, new technologies mean we have been able to get moving on a potential vaccine with unprecedented speed. We’ve been able to produce a vaccine from scratch and take it to human trials in just a few months – from code to candidate – which has never been done before with this type of vaccine. If our approach works and the vaccine provides effective protection against disease, it could revolutionise how we respond to disease outbreaks in future.”
Many traditional vaccines are based on a weakened or modified form of virus, or parts of it, but the Imperial vaccine is based on a new approach. It uses synthetic strands of genetic code (called RNA), based on the virus’s genetic material.
Once injected into muscle, the RNA self amplifies – generating copies of itself – and instructs the body’s own cells to make copies of a spiky protein found on the outside of the virus. This should train the immune system to respond to the coronavirus so the body can easily recognise it and defend itself against COVID-19 in future.
In the initial part of the study, the team will look to assess safety and find the optimal dose of the vaccine in 15 healthy participants aged 18 to 45 at a West London facility. The first participant will receive a very low dose of the vaccine, before the team escalates to increasingly higher doses for subsequent volunteers.
Following this initial small group, the team will then recruit further healthy volunteers (aged 18-75) to trial the optimal dose of vaccine in a larger population. The combined Phase I/II studies will aim to deliver the vaccine to a total of 300 people at the West London facility and additional sites.
All volunteers will receive two doses of the vaccine over two visits – an initial dose and then a second boosting dose four weeks later. The researchers expect to publish findings once the safety data are available and are hopeful a viable vaccine could be available as early as Spring 2021.
Dr Katrina Pollock, from Imperial’s department of infectious disease and chief investigator of the study, said: “These clinical studies are crucial in showing the safety of any new vaccine, and demonstrating the immune response it produces. We need to assess whether the vaccine can train the immune system to defend itself against COVID-19. The vaccine can then be rolled out to more people in the UK and beyond in pivotal trials.”
The research has been supported by the UK Medical Research Council, UK Research and Innovation, The Department of Health and Social Care, the Department for Business, Energy and Industrial Strategy, the National Institute for Health Research, along with a number of philanthropic donations.
[link url="https://www.imperial.ac.uk/news/198314/imperial-begin-first-human-trials-covid-19/"]Imperial College London material[/link]