Following the vaccination of more than 15 million people with at least their first jab across the UK, the first study to assess the safety and immune response of the Covid-19 vaccine in children and young adults is set to begin.
The study, which will be funded and supported by NIHR and run by the University of Oxford, will focus on using the Oxford vaccine - currently approved and being given to adults by the NHS.
Building on previous clinical trials of the vaccine, which have shown it to be safe, produce a strong immune system response and have high efficacy levels in all adults, this new trial will assess whether children and young adults, from 6-17 years of age, also display a good immune response to the vaccine.
It will seek to enrol 300 volunteers and operate as a single-blind, randomised phase II trial. Of those who volunteer, up to 240 will receive the Oxford vaccine while the remainder receive a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as soreness at the injection site.
To improve the pool of participants they could recruit, the researchers will work together with three partner sites in London, Southampton and Bristol.
Professor Andrew Pollard, Professor of Paediatric Infection and Immunity and Chief Investigator on the Oxford vaccine trial, said: "While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination.
“These new trials will extend our understanding of control of SARS-CoV2 to younger age groups."
Dr William van’t Hoff, Chief Executive of NIHR’s Clinical Research Network, added: "We’ve already seen the contribution of Covid-19 vaccine research in the UK to protecting adults.
“I’m delighted the launch of this trial will extend our knowledge of how to protect children and young adults in the future."
The trial officially launched on February 13, 2021 and the first vaccinations are expected during the month of February.
Further information on the trial, including how to sign up, can be found by visiting here.
