Researchers at University Hospital Southampton (UHS) and the University of Southampton have begun recruiting new volunteers for the next two phases in human trials of a vaccine pioneered in the UK which could protect against COVID-19.
Originally, the phase I trial in Southampton involved 160 healthy volunteers aged between 18 and 55. For phases II and III, part of the study involves increasing the number of people involved to up to 10,260 people across a number of partner institutions across the UK, whilst expanding the age range of those in which the vaccine will be assessed to include older adults and children.
Southampton researchers are now seeking to recruit up to 620 new volunteers in the following categories:
- initially 250 people aged 18-55, who come into contact or possible contact with COVID patients as part of their work including, but not limited to, all care home staff, (nurses, care assistants, cleaners etc), paramedics, frontline hospital staff and cleaners/catering staff who go into frontline areas, dentists, GPs and GP surgery staff, including nurses;
- 120 otherwise healthy people over 70;
- a further otherwise healthy group of 250 people over 55, including over 70s
For these groups, in phase II, researchers will assess 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 phase III part of the study will involve assessing how the vaccine works in a large number of people over 18. This group will assess how well the vaccine works to prevent people from being infected and unwell with COVID-19.
“The early stages of the phase I trial have gone very well and we’re grateful for the many volunteers from Southampton who have come forward to help us assess the safety of the new vaccine and if healthy people can be protected from COVID-19,” said Professor Saul Faust, Professor of Paediatric Immunology and Infectious Diseases at the University of Southampton and Director of the NIHR Southampton Clinical Research Facility at UHS.
“We would now very much like to invite people from the Southampton area whose work brings them into possible contact with COVID patients or who are healthy and in the older age groups to take part in the next stage of trials of this Oxford COVID vaccine,” Professor Faust continued. “This is one of only four vaccine trials underway worldwide and could pave the way for a vaccine to be delivered later this year.”
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.
ChAdOx1 nCoV-19 is made from a weakened version of a common cold virus (adenovirus) from chimpanzees that has been genetically changed so that it is impossible for it to grow in humans.
This has been combined with genes that make proteins from the COVID-19 virus (SARS-CoV-2) called spike glycoprotein which play an essential role in the infection pathway of the SARS-CoV-2 virus.
Half of volunteers in the study will receive either the COVID-19 vaccine and the other half will be given a licensed ‘control’ vaccine against meningitis and sepsis (the conjugate MenACWY vaccine) as comparison. Production of the vaccine has already been scaled up pre-trial to prepare as early as possible for potential future deployment.
“Those joining the trial will be playing a critical role in the global search for a vaccine that protects us all,” Professor Faust concluded.