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Researchers at Imperial College London in the UK are set to begin Phase I/II clinical trials of a Covid-19 vaccine candidate based on self-amplifying RNA technology.
The trial will assess the vaccine candidate’s tolerability and effectiveness in generating an immune response.
According to researchers, the vaccine leverages synthetic strands of RNA based on the virus’ genetic material. Upon injection into the muscle, the RNA self amplifies and induces the body’s cells to produce copies of a spike protein present on the virus.
This is expected to train the immune system to identify and protect against Covid-19. The UK Government has provided more than £41m in funding to support development and clinical studies of the vaccine.
In pre-clinical safety tests and animal studies, the vaccine was observed to be safe and demonstrated encouraging signs of an effective immune response, noted the researchers.
The Phase I/II trials will assess two doses of the vaccine in 300 healthy participants. Based on the results, Phase III effectiveness studies will be performed later this year in nearly 6,000 healthy volunteers.
A viable vaccine is expected to be made available next year.
Study chief investigator Dr Katrina Pollock 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.”
Imperial College London has established VacEquity Global Health (VGH), a new social enterprise, in collaboration with Morningside Ventures, to develop its Covid-19 vaccine.
VGH will focus on rapid development of vaccines to prevent SARS-CoV-2 infection and distribute them in the UK and internationally, including to low and middle-income countries.