The University of Oxford has launched the first study of ChAdOx1 nCoV-19 Covid-19 vaccine in children and young adults.
The single-blind, randomised phase II trial, launched along with three partner sites in London, Southampton and Bristol, will analyse the vaccine’s safety and check whether it could elicit a good immune response in children and young adults aged six to 17 years.
It will enrol 300 subjects, with approximately 240 of them receiving the ChAdOx1 nCoV-19 vaccine. The remaining subjects will receive a control meningitis vaccine demonstrated to be safe in children.
Previous trials showed that the vaccine is safe, produces strong immune system responses and has high efficacy in all adults.
University of Oxford Paediatric Infection and Immunity professor and chief investigator of the trial 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.”
Funded by the National Institute for Health Research (NIHR) and AstraZeneca, the trial is likely to begin first vaccinations this month.
The institute noted that the study data may be used to support larger-scale trials in children. Also, AstraZeneca may use such trial results for supporting approvals of the vaccine for use in children.
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 programmes in the near future.”