22.07.20
University of Oxford coronavirus vaccine begins next phase of trials
Researchers at the University of Oxford have begun recruiting for the next phase in human trials of a coronavirus vaccine in human volunteers.
After the phase I trial in healthy adult volunteers began in April, with more than 1,000 immunisations having been completed and the follow-ups currently ongoing, the researchers are now looking to recruit ahead of the phase II and phase III parts of the vaccine study.
The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country.
For the phase II part of the study, it will involve expanding the age range of people the vaccine is assessed in to include a small number of older adults and children:
- Aged 56-69
- Aged over 70
- Aged between 5-12 years
Researchers will be assessing the immune response to the vaccine in people of different ages, in order to discover if there is variation in how well the immune system responds in older people or children.
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 and 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 ChAdOx1 nCoV-19 vaccine is made from a virus (ChAdOx1) which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, which has been genetically changed so that it is impossible for it to replicate in humans.
Professor Andrew Pollard, Head of the Oxford Vaccine Group, said: '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.
“We are very grateful to the huge support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus.'
Sarah Gilbert, Professor of Vaccinology at the Jenner Institute, said: '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.
“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.”
The study aims to assess how well people across a broad range of ages could be protected from Covid-19 with this new ChAdOx1 nCoV-19 vaccine. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.