Human trials of new coronavirus vaccine are due to begin this week

17 June 2020

GMP News

Scientists at Imperial College London will start the first clinical trials of a potential COVID-19 vaccine this week with more than 45 million pounds ($56.50 million) in backing from the British government and philanthropic donors.

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.

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.

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.

Professor Robin Shattock, from the Department of Infectious Disease at Imperial and who is leading the work, said: «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.

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.

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