A trial of a coronavirus vaccine by researchers at the University of Oxford aims to achieve efficacy results by September, and production is already underway.
A team led by Sarah Gilbert, a professor of vaccinology, recruited 500 volunteers aged 18 to 55 for the early or intermediate randomized controlled trial. It will be extended to the elderly and then to a final trial of 5,000 people. Gilbert said the schedule is ambitious but achievable.
“We hope to have at least a few doses that are ready for use by September,” she said in an interview. “There won’t be enough for everywhere by then, but the more we can manufacture from now on, the more doses there will be. “
Volunteers to participate in the trial were numerous, she said, and he no longer accepts new subjects.
Gilbert, whose research on vaccines began at Oxford University in 1994, has received a £ 2.2 million ($ 2.8 million) grant from the National Institute for Health Research in the United Kingdom and from UK Research and Innovation in March to step up their team’s efforts for COVID-19 vaccine research.
The group’s experimental vaccination is among the first to enter clinical trials. The World Health Organization has 70 candidate vaccines in development, three of which are in human tests. They are from CanSino Biological Inc. and the Beijing Institute of Biotechnology; Inovio Pharmaceuticals Inc .; and Moderna Inc. with the National Institute of Allergies and Infectious Diseases.
Gilbert’s trial divides 510 participants into five groups who will be observed for approximately six months with the option of a follow-up visit approximately one year after starting the trial. One group will receive a second intramuscular injection of the vaccine four weeks after the initial vaccination.
The research is aimed at determining the efficacy, safety and immunogenicity of the candidate vaccine, called ChAdOx1 nCoV-19. A meningococcal vaccine will be administered to participants who will be randomly selected for control.
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ChAdOx1 nCoV-19 is a so-called recombinant viral vector vaccine. It is made from a harmless virus that has been engineered to produce the advanced surface protein of the SARS-CoV-2 virus that causes the pandemic.
The vaccine works by priming the immune system to recognize and attack the coronavirus, stimulating a T-cell response. It uses the same technology as a team from Gilbert previously developed for the related MERS coronavirus. This vaccine appears to be safe in tests on animals and humans at an early stage, which gives confidence in the version of the coronavirus.
“We are doing security testing,” said Gilbert, “but we are not worried. “
Gilbert’s team has used the same technology for about 10 different vaccines, she said. The challenge now is to test the vaccine even if the rates of viral infection vary.
“It will be complicated to try to determine the effectiveness of the vaccine when the transmission of the virus to different places increases and then decreases,” she said. “The trial has to be set up in the right place at the right time and it is very difficult to predict. This is why we plan to do several tests in several countries. “
Another obstacle is money.
“We have funds but we don’t have them all yet,” she said. “You can’t just start manufacturing on a large scale. You have to put a lot of things in place and that is what we are trying to do right now. It’s in the tens of millions of pounds. “
WHO is creating a forum for all those who are developing COVID-19 vaccines to share their plans and initial findings, according to Gilbert.
“The work is continuing at a very rapid pace,” she told the Lancet medical journal, “and I have no doubt that we will see an unprecedented spirit of collaboration and cooperation, summoned by the WHO, as we are moving towards a common global goal of preventing COVID-19 through vaccination. “
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