Clinical Trails For COVID-19 Vaccine Set To Start

Clinical researchers will begin human trials of a new coronavirus vaccine developed by researchers at Imperial College London.

Beginning this week, 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.

Photo credits: Thomas Angus / Imperial College London.

This latest milestone follows £41 million in government funding towards the development of Imperial College London’s vaccine.

A further £5 million of philanthropic gifts, including from hundreds of members of the public, has accelerated the work.

The trials 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 has been shown to be safe and produced encouraging signs of an effective immune response in animal studies.

Over the coming weeks, 300 healthy participants will receive two doses of the vaccine.

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.

If the vaccine shows a promising immune response, 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.”

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 COVID-19 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.”

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.

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).