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.
Work on the vaccine, developed by clinical teams at the University of Oxford’s Jenner Institute and Oxford Vaccine Group, began in January. Originally, the phase I trial in Southampton involved 160 healthy volunteers aged between 18 and 55.
For phases II and III, the study involves increasing the number of people involved to up to 10,260 people across the UK, involving a number of partner institutions, whilst expanding the age range of those the vaccine is assessed in to include older adults and children.
Call for volunteers
Southampton researchers are now seeking to recruit up to 620 new volunteers in the following categories:
- 250 people aged 18-55 at increased risk of coming into contact with the virus, including: anyone who works in care homes (including cleaners, nurses, care assistants); paramedics, frontline hospital staff and cleaners/catering staff who go into frontline areas, dentists, GPs and GP surgery staff, including nurses;
- 120 people over 70 (first fill group);
- 250 people over 55, including over 70s (second fill group).
Click here for further information and to sign-up to volunteer.
Scaling up
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 enable us, so far, to assess if healthy people can be protected from COVID-19 with this new vaccine and to give us valuable information on its safety and ability to generate good immune responses against the virus,” 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.
“It’s now very important that more people from Southampton in the age groups we’ve specified – ‘at risk’ people aged 18-55 and healthy people over 55, including those over 70 - come forward to volunteer for screening so that we can quickly increase the number of people taking part in the trials and continue to support our colleagues in Oxford on this extremely important study. This is one of only four vaccine trials underway worldwide and could pave the way for a vaccine to be delivered later this year,” he continues.
About the vaccine
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, not least frontline NHS workers, the elderly and those with underlying health conditions,” concludes Professor Faust, a consultant in immunology and infectious diseases.
To find out more about the study and how to take part, visit https://covid19vaccinetrial.co.uk/participate-southampton.
Posted on Friday 22 May 2020