The University of Oxford, along with three partner sites in the UK, has commenced the first trial to evaluate the safety and immune responses in children and young adults of the ChAdOx1 nCoV-19 coronavirus vaccine.
The three partner sites in London, Southampton and Bristol.
Building on earlier studies of the vaccine that have shown that it is safe, produces strong immune system responses and has high efficacy in all adults, this study will evaluate if children and young adults aged between six and 17 years get a good immune response with the ChAdOx1 nCoV-19 vaccine.
This is a single-blind, randomised phase II trial, and will see enrollment of 300 volunteers.
Up to 240 of these volunteers will receive the ChAdOx1 nCoV-19 vaccine while the rest will get a control meningitis vaccine, which has been shown to be safe in children but is expected to lead to similar reactions, such as a sore arm.
Chief investigator on the Oxford vaccine trial and professor of paediatric infection and immunity Andrew Pollard 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.’
Oxford Vaccine Group paediatrician and clinician-scientist Rinn Song said: “The COVID-19 pandemic has had a profound negative impact on the education, social development and emotional well-being of children and adolescents, beyond illness and rare severe disease presentations.
“It is therefore important to collect data on the safety and the immune response to our coronavirus vaccine in these age groups, so that they could potentially benefit from inclusion in vaccination programs in the near future.’
First vaccinations are expected to be done in this month.
This study is funded by the National Institute for Health Research (NIHR) and AstraZeneca.