13 February 2021
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.
For further information on the trial, including on how to sign up, visit: covid19vaccinetrial.co.uk
Notes to editors:
For further information or to arrange an interview, please contact the University of Oxford press office at firstname.lastname@example.org or on +44 (0)1865 280528
This is the first trial of a COVID-19 vaccine in the age group 6-17 years. Some trials have begun in teenagers (16/17 years). None of them are yet licensed for younger children.
For more about the Oxford vaccine project and team: www.ox.ac.uk/covid-vaccine
Previous papers published on this project:
- Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
M Voysey, S A Costa Clemens, S A Madhi, L Y Weckx, P M Folegatti, P K Aley, et al.
The Lancet 2020.
- Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. M N Ramasamy, A M Minassian, K J Ewer, A L Flaxman, P M Folegatti, D R Owens, et al. The Lancet 2020.
- Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. P Folegatti, K Ewer, C Green, A Douglas, A Hill, T Lambe, S Gilbert, A Pollard et al. The Lancet 2020.
- Evaluation of the immunogenicity of prime-boost vaccination with the replication-deficient viral vectored COVID-19 vaccine candidate ChAdOx1 nCoV-19. Graham, Lambe et al. NPJ Vaccines 2020.
- ChAdOx1 nCoV-19 vaccine prevents SARS-CoV-2 pneumonia in rhesus macaques. van Doremalen, Lambe et al. Nature. 2020.
- A booster dose enhances immunogenicity of the COVID-19 vaccine candidate ChAdOx1 nCoV-19 in aged mice. Lambe, Linterman et al. Med (2020).
- Intranasal ChAdOx1 nCoV-19/AZD1222 vaccination reduces shedding of SARS-CoV-2 D614G in rhesus macaques. Lambe, Munster et al. Pre-print bioRxiv (2021).
- ChAdOx1 nCoV-19 protection against SARS-CoV-2 in rhesus macaque and ferret challenge models. Lambe, Spence et al. Pre-print ResearchSquare (2021).
- Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine. M Voysey, S A Costa Clemens et al. Pre-Print Preprints with THE LANCET (2021)
- Efficacy of ChAdOx1 nCoV-19 (AZD1222) Vaccine Against SARS-CoV-2 VOC 202012/01 (B.1.1.7). Emary, Golubchik et al. Pre-Print Preprints with THE LANCET (2021)
For detailed information about the vaccine trial: covid19vaccinetrial.co.uk
Images: Credit: University of Oxford, John Cairns
- Oxford Vaccine Vial:
- Mobile Clinic for trial volunteers:
- Oxford Vaccine Group labs:
- Downloadable researcher interviews and b-roll for video editors and broadcast:
https://vimeo.com/showcase/7803812 contact the News office for the password
NOTE: These are for downloading and editing by media outlets, not for uploading or using wholesale.
- Short explainer video for social media or embed: https://youtu.be/xHJ_RqeXXy0
About the Oxford COVID-19 vaccine
ChAdOx1 nCoV-19, now known as AZD1222 co-invented by the University of Oxford and its spin-out company, Vaccitech, is being trialled by the University’s Jenner Institute and Oxford Vaccine Group. The team started working to develop a vaccine against coronavirus in January 2020.
Developed at the Jenner Institute, the recombinant adenovirus vector ChAdOx1 nCoV-19 uses a viral vector based on a weakened version of the common cold virus (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body.
Over 50,000 people to date have taken part in clinical trials of The ChAdOx1 nCoV-19 vaccine sponsored by the University of Oxford and AstraZeneca, and many more have received the vaccine through public vaccination programmes following emergency use licensure. It has been shown to be safe and well tolerated, although it can cause temporary side effects, such as a temperature, flu-like symptoms, headache or sore arm.
The potential vaccine entered Phase III clinical trials in May to study safety and efficacy in healthy volunteers. In total, nearly 24,000 volunteers have joined the University of Oxford sponsored trial, in sites around the UK (approximately 12,000 volunteers), Brazil (approximately 10,000 volunteers) and South Africa (approximately 2,000 volunteers). Interim efficacy and safety data were published in The Lancet in December, including an extensive safety database of over 74,000 ‘person months’ of safety data follow-up.
Our partners, AstraZeneca, have committed to delivering billions of doses of its COVID-19 vaccine across the globe in a broad, equitable, and timely way at no profit during the pandemic. This includes an agreement with the European Commission to supply up to 400 million doses, starting in early 2021 following the regulatory approval from the European Medicines Agency, with tens of millions of doses due to be supplied in February and March.
For more information on this commitment, visit: https://www.astrazeneca.com/content/astraz/media-centre/articles/2021/astrazenecas-covid-19-vaccine-european-union-supply-commitment.html
Not for profit information:
As part of our agreement with our partner AstraZeneca, the vaccine will be supplied on a not-for-profit basis for the duration of the pandemic and in perpetuity for low- and middle-income countries, with any future royalties received by the University of Oxford being re-invested in the medical sciences.
This trial is funded by the National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites.
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