Imperial to begin first human trials of new COVID-19 vaccine

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 is being developed and trialled thanks to more than £41 million in funding from the UK government and a further £5m in philanthropic donations. It 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.”

Business Secretary, Alok Sharma, said: “I am incredibly proud the vaccine being developed by Imperial College London is one of the world’s front-runners. We are fully backing its research with over £40 million government funding, as part of our wider vaccines development programme.

“The fast progress of Imperial’s vaccine is testament to the ingenuity and tenacity of Britain’s researchers. If these trials are successful a vaccine will not only help us tackle coronavirus but also emerging diseases now and into the future.

Kate Bingham, Vaccine Taskforce Chair, said: “I am delighted that Imperial College have so quickly advanced to the clinical trial stage. Their self-amplifying technology has the potential to be a real game-changer, not only for a COVID19 vaccine but for the development of future vaccines. It’s a great example of the world-leading life sciences sector in this country. By backing Imperial College London and their alternative vaccine platform, we have enhanced the UK’s vaccine portfolio, increasing our chances of identifying a successful vaccine”

Professor Fiona Watt, Executive Chair of the Medical Research Council, which helped fund the trial, said: “In less than six months from the first reports of the emergence of COVID-19 in China, and with support from UKRI and DHSC, we now have two promising UK vaccines in human trials. This astonishingly fast vaccine development – compared to the years it normally takes – is a result of the remarkably hard and collaborative work of the scientists, trialists and regulators. These human trials will contribute to global efforts to find a vaccine, which is our best hope for preventing COVID-19 and enabling life to return to normal.”

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.

Imperial has formed a new social enterprise VacEquity Global Health (VGH), in partnership with Morningside Ventures, to develop its COVID-19 vaccine. The mission of VGH is to rapidly develop vaccines to prevent SARS-CoV-2 infection and distribute them as widely as possible in the UK and overseas, including to low- and middle-income countries.

The Imperial vaccine trial is progressing with approval from the Medicine and Healthcare products Regulatory Agency (MHRA).

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