The University of Oxford, together with three partner sites in London, Southampton and Bristol, is to launch the first study to assess the safety and immune responses in children and young adults of the ChAdOx1 nCoV-19 coronavirus vaccine.
Building on previous trials of the vaccine, which have shown that it is safe, produces strong immune system responses and has high efficacy in all adults, this trial will assess if children and young adults aged 6-17 years make a good immune response with the ChAdOx1 nCoV-19 vaccine.
This new trial, a single-blind, randomised phase II trial, will enrol 300 volunteers, with up to 240 of these volunteers receiving the ChAdOx1 nCoV-19 vaccine and the remainder a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as a sore arm.
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.’
Rinn Song, Paediatrician and Clinician-Scientist, Oxford Vaccine Group, 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.’
Grace Li, Paediatric Clinical Research Fellow, Oxford Vaccine Group, said:
‘This study will play an important role in helping to protect children in the future. We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve.’
The trial is launched today, and first vaccinations are expected during February. The trial is funded by the National Institute for Health Research (NIHR) and AstraZeneca.