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First human trials of new COVID-19 vaccine to start

 

Clinical researchers are this week set to begin the first human trials of a new coronavirus vaccine developed with support from the NIHR.

Many traditional vaccines are based on a weakened or modified form of a virus, or parts of it, but this vaccine uses synthetic strands of SARS-CoV-2 genetic material (RNA).

Prof Robin Shattock and his team at Imperial College London have modified the RNA for the virus’ ‘spike’ surface protein to create a stabilised version. 

When the new vaccine is injected, it delivers the genetic instructions for the SARS-CoV-2 ‘spike’ surface protein to muscle cells. These cells then make this protein to provoke an immune response and create immunity to the virus. 

The new trial will test whether the vaccine is well tolerated in healthy volunteers and whether it 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. 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 COVAC1 vaccine candidate 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 participants will receive two doses of the vaccine, followed by larger phase III trials involving a further 6,000 people if the vaccine generates a promising immune response in humans.

Professor Robin Shattock, from the Department of Infectious Disease at Imperial, 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.”

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 MP 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 £41 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."

The research has received £1.7 million from the NIHR and UK Research and Innovation, as well as further funding from the Department of Health and Social Care, the Department for Business, Energy and Industrial Strategy, and a number of philanthropic donations.

The study has been designated as Urgent Public Health Research by the NIHR, to expedite its set up and delivery in the health and care system by the NIHR Clinical Research Network.

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