COVID-19 Vaccine By UK’s Imperial College Enters Human Trials

Imperial College COVID-19 Vaccine Human Trials Initiated

Human trials of a new coronavirus vaccine developed by the Imperial College London scientists began this week. 

The study will test whether the vaccine is well-tolerated and produces an effective immune response against COVID-19 and involves a set of people being immunized with the vaccine.

A professor who is leading the work, from the Department of Infectious Disease at Imperial, Professor Robin Shattock said, “New technologies, from a scientific perspective mean that we have been able to get moving with unprecedented speed on a potential vaccine. In just a few months, we have been able to take the vaccine from code to candidate – to human trials after producing it from scratch. The way we respond to disease outbreaks in the future could be revolutionized if our approach works and the vaccine provides effective protection against disease.”

They say the vaccine has been shown to be safe and produced encouraging signs of an effective immune response as it has undergone rigorous pre-clinical safety tests and in animal studies. Imperial College London’s vaccine candidate has the potential to revolutionize vaccine development and enable scientists to respond more quickly to emerging diseases as it will

be the first test of a new self-amplifying RNA technology.

Two doses of the vaccine will be given to 300 healthy participants over the coming weeks. To test its effectiveness, a larger Phase III trials with around 6,000 healthy volunteers, would be planned to begin later in the year, if the vaccine is safe and shows a promising immune response in humans.

Ultimately, the vaccine could provide protection against COVID-19 both in the UK and around the world if clinical trials are successful.

 The Chief Investigator of the study from Imperial’s Department of Infectious Disease, Dr. Katrina Pollock said, ” In demonstrating the immune response produced by the vaccine and in showing the safety of any new vaccine, these clinical studies are crucial. Whether the vaccine is capable of training the immune system to defend itself against COVID-19 needs to be assessed. To more people in the UK and beyond in pivotal trials, the vaccine can be rolled out after this.”

In the initial part of the study, in 15 healthy participants aged 18 to 45 at a west London facility, the team will look to assess the safety and find the optimal dose of the vaccine. Before the team escalates to increasingly higher doses for subsequent volunteers, the first participant will receive a very low dose of the vaccine.

To trial the optimal dose of vaccine in a larger population, the team will then recruit further healthy volunteers (aged 18-75) following this initial small group. To a total of 300 people at the west London facility and additional sites, the team aims to deliver the vaccine in combined Phase I/II study. Two doses of the vaccine over two visits – an initial dose and then four weeks later, a second boosting dose will be given to all volunteers.

The Imperial vaccine is based on a new approach, based on the virus’s genetic material, it uses synthetic strands of genetic code (called RNA). The RNA instructs the body’s own cells to make copies of a spiky protein found on the outside of the virus as it generates copies of itself and self amplifies once injected into the muscle. The immune system will be trained to respond to the coronavirus by this process in such a way that, in the future, the body can defend itself against COVID-19 by easily recognizing it.

Vaccine Taskforce Chair, Kate Bingham said, “Not just for a COVID-19 vaccine but for the development of future vaccines, the Imperial College’s self-amplifying technology has the potential to be a real game-changer. It’s a great example of the world-leading life sciences sector in this country and it is delightful to see them so quickly advanced to the clinical trial stage. We have enhanced the UK’s vaccine portfolio, increasing our chances of identifying a successful vaccine by backing Imperial College London and their alternative vaccine platform.”

Funding of around 5 million pounds in philanthropic donations and 41-million pound UK government funding has been provided for Imperial College London’s vaccine candidate to be developed and trialed.

The researchers are hopeful a viable vaccine could be available in the first half of 2021 and once the safety data are available, they expect to publish the findings.

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