The University of Oxford has launched the first study to assess the safety and immune responses in children and young adults of its coronavirus vaccine.
The university said that previous trials of its ChAdOx1 nCoV-19 jabs, which are being produced by AstraZeneca and also have a tie-up with the Serum Institute of India, have shown that it is safe, produces strong immune system responses and has high efficacy in all adults.
From Friday, it would be extending its trials to assess if children and young adults aged 6-17 years also show a good immune response to coronavirus from it.
“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,” said Andrew Pollard, Professor of Paediatric Infection and Immunity, and Chief Investigator on the Oxford vaccine trial.
“These new trials will extend our understanding of control of SARS-CoV2 to younger age groups,” he said.
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.
“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,” said Rinn Song, Paediatrician and Clinician-Scientist, Oxford Vaccine Group.
“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,” he said.
After the launch of the trial funded by the National Institute for Health Research (NIHR) and AstraZeneca this week, the first vaccinations are expected during the course of this month.
“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,” said Grace Li, Paediatric Clinical Research Fellow, Oxford Vaccine Group.
The university said it has teamed up with three partner sites in London, Southampton and Bristol for this extended vaccine trial.