University of Oxford researchers working on a vaccine to protect against coronavirus on Friday confirmed that they are moving to the next level as they begin recruiting over 10,000 people for the second phase of human trials.
The first phase of the trial began last month with 1,000 healthy adults aged 55 and under as volunteers. Now more than 10,200 people, including over 70s and five to 12-year-olds, will be enrolled in the study, to see the effects on their immune system.
A recent study had found that the vaccine, named ChAdOx1 nCoV-19, had shown some promising results in a small study with monkeys.
The COVID-19 vaccine trial team have been working hard on assessing the safety and immunogenicity of ChAdOx1 nCoV-19, and preparing to assess vaccine efficacy, said Sarah Gilbert, professor of vaccinology at the university's Jenner Institute who is leading the research.
We have had a lot of interest already from people over the age of 55 years who were not eligible to take part in the phase I study, and we will now be able to include older age groups to continue the vaccine assessment. We will also be including more study sites, in different parts of the country, she said.
ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.
For the latest set of volunteers, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.
"The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population, said Professor Andrew Pollard, head of the Oxford Vaccine Group.
The Phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18.
This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19. Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a control for comparison, the university said.
Mene Pangalos, Executive Vice President for BioPharmaceuticals R&D at AstraZeneca, which has a partnership with the university for the production of the vaccine if it is proved effective, said: The speed at which this new vaccine has advanced into late-stage clinical trials is testament to Oxford's ground-breaking scientific research.
We will do everything in our power to engage with governments, multilateral organisations and partners around the world to increase production and distribution and ensure rapid, fair and equitable distribution of a globally accessible vaccine.
The study aims to assess how well people across a broad range of ages could be protected from Covid-19 with this new vaccine. It will also provide valuable information on the safety aspects of the vaccine and its ability to generate good immune responses against the virus.
The team behind the vaccine have previously said they are aiming to have at least a million doses of a coronavirus vaccine by September this year. However, the UK government has repeatedly warned that there are no guarantees a vaccine will be discovered against the deadly virus.
The Oxford University trial is among several experimental vaccines being developed worldwide to try and combat the spread of Covid-19 and help lift strict restrictions on human movement in place in most countries.