Clinical Trial

. 2025 Aug 30:62:127597.

doi: 10.1016/j.vaccine.2025.127597. Epub 2025 Aug 25.

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: Final results of a phase 2, single-blind, randomised controlled trial (COV006)

Grace Li¹, Natalie G Marchevsky², Grace Macaulay², Parvinder Aley², Hannah Baughan², Emma Plested², Sagida Bibi², Federica Cappuccini², Saul N Faust³, Paul T Heath⁴, Jill Muller², Hannah Robinson², Marion Roderick⁵, Matthew Snape², David Smith², Rinn Song², Xinxue Liu², Teresa Lambe⁶, Andrew J Pollard⁷; COV006 trial team

Collaborators, Affiliations

Collaborators

COV006 trial team:
Robert Aley⁸, Rachel Anslow⁹, Katrina Cathie¹⁰, Rachel Cooper¹¹, Shuo Feng¹², Simon Kerridge¹³, Alice Lelliott¹⁴, Yama Mujadidi¹⁵, Khuen Ng¹⁶, Sarah Rhead¹⁷, Nisha Singh¹⁸, David Smith¹⁹, Karly Tang²⁰, Andy Yao²¹, Ruth Drury²², Emily Lees²³, Helen Ratcliffe²⁴, Matthew Rajan²⁵, Kushalinii Hillson²⁵, Stanislava Koleva²⁶, Jill Muller²⁷, Danielle Woods²⁸, Sophie Davies²⁹, Eva Galiza³⁰, Natalina Sutton³¹, Jennifer J P Pearce³², Cecilia L Hultin³³, Luis de Luna George³⁴, Nicole M M Branch³⁵, Zsofia Danos³⁶, Emily R Beales³⁷, Shari S S Sapuan³⁸, Adam Boon³⁹, Sofia Cuevas-Asturias²⁵, Isabel Rowbotham⁴⁰, Samantha Thomson-Hill⁴¹, Leila Godfrey⁴², Helen Sanders⁴³, Jamie Fowler⁴⁴, Reece Mabbett⁴⁵, Hannah Sharpe⁴⁶, Emma Sheehan⁴⁷, Jeremy Aboagye⁴⁸, Marta Ulaszewska⁴⁹, Amy Flaxman⁵⁰, Daniel R Owens⁵¹, Alasdair P S Munro⁵², Abigail L Oliver⁵³, Jonathan F Baker⁵⁴, Sally Salter⁵⁵, Rachel Brampton⁵⁶, Louise Haskell⁵⁷, Wythehi Ambihapathy⁵⁸, Guneswary Thaygaraja⁵⁹, Cornish L Emily⁶⁰

Affiliations

¹ Oxford Vaccine Group, University of Oxford, UK. Electronic address: g.li@nhs.net.
² Oxford Vaccine Group, University of Oxford, UK.
³ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
⁴ Vaccine Institute, St George's, University of London and St George's University Hospitals NHS Trust, London, UK.
⁵ Bristol Royal Hospital for Children, University of Bristol, Bristol, UK.
⁶ Oxford Vaccine Group, University of Oxford, UK; Chinese Academy of Medical Sciences Oxford Institute, Oxford, UK.
⁷ Oxford Vaccine Group, University of Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK, Oxford, UK.
⁸ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: robert.aley@paediatrics.ox.ac.uk.
⁹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: rachel.anslow@paediatrics.ox.ac.uk.
¹⁰ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: k.cathie@soton.ac.uk.
¹¹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: rachel.cooper@paediatrics.ox.ac.uk.
¹² Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: shuo.feng@paediatrics.ox.ac.uk.
¹³ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: simon.kerridge@paediatrics.ox.ac.uk.
¹⁴ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: alice.lelliott@nhs.net.
¹⁵ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: yama.mujadidi@paediatrics.ox.ac.uk.
¹⁶ Bristol Royal Hospital for Children. Electronic address: khuenfoong.ng@nhs.net.
¹⁷ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: sarah.rhead@paediatrics.ox.ac.uk.
¹⁸ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: nisha.singh@paediatrics.ox.ac.uk.
¹⁹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: david.smith@ndorms.ox.ac.uk.
²⁰ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: karly.tang@paediatrics.ox.ac.uk.
²¹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: andy.yao@paediatrics.ox.ac.uk.
²² Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: ruth.drury@paediatrics.ox.ac.uk.
²³ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: emily.lees@paediatrics.ox.ac.uk.
²⁴ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: helen.ratcliffe@paediatrics.ox.ac.uk.
²⁵ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford.
²⁶ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: stanislava.koleva@paediatrics.ox.ac.uk.
²⁷ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: jill.muller@paediatrics.ox.ac.uk.
²⁸ Jenner Institute, University of Oxford. Electronic address: danielle.woods@ndm.ox.ac.uk.
²⁹ Jenner Institute, University of Oxford. Electronic address: sophie.davies@ndm.ox.ac.uk.
³⁰ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: egaliza@sgul.ac.uk.
³¹ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: nsutton@sgul.ac.uk.
³² Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: jpearce@sgul.ac.uk.
³³ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: chultin@sgul.ac.uk.
³⁴ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ldelunag@sgul.ac.uk.
³⁵ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: nicole.branch@nhs.net.
³⁶ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: zdanos@sgul.ac.uk.
³⁷ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ebeales@sgul.ac.uk.
³⁸ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ssapuan@sgul.ac.uk.
³⁹ University of Bristol. Electronic address: adam.boon@bristol.ac.uk.
⁴⁰ Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: ir13772@bristol.ac.uk.
⁴¹ University of Bristol. Electronic address: sam.thomson-hill@bristol.ac.uk.
⁴² Jenner Institute, University of Oxford. Electronic address: leila.godfrey@ndm.ox.ac.uk.
⁴³ Jenner Institute, University of Oxford. Electronic address: helen.sanders@ndm.ox.ac.uk.
⁴⁴ Jenner Institute, University of Oxford. Electronic address: jamie.fowler@ndm.ox.ac.uk.
⁴⁵ Jenner Institute, University of Oxford. Electronic address: reece.mabbett@ndm.ox.ac.uk.
⁴⁶ Jenner Institute, University of Oxford. Electronic address: hannah.sharpe@seh.ox.ac.uk.
⁴⁷ Jenner Institute, University of Oxford. Electronic address: emma.sheehan@ndm.ox.ac.uk.
⁴⁸ Jenner Institute, University of Oxford. Electronic address: jeremy.aboagye@ndm.ox.ac.uk.
⁴⁹ Jenner Institute, University of Oxford. Electronic address: marta.ulaszewska@ndm.ox.ac.uk.
⁵⁰ Jenner Institute, University of Oxford. Electronic address: amy.flaxman@ndm.ox.ac.uk.
⁵¹ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: d.owens@soton.ac.uk.
⁵² NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: a.munro@soton.ac.uk.
⁵³ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: abigail.oliver@uhs.nhs.uk.
⁵⁴ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: jonathan.baker@uhs.nhs.uk.
⁵⁵ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: sally.salter@uhs.nhs.uk.
⁵⁶ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: rachel.brampton@uhs.nhs.uk.
⁵⁷ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: louise.haskell@uhs.nhs.uk.
⁵⁸ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: Wythehi.Ambihapathy@uhs.nhs.uk.
⁵⁹ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: guneswary.thaygaraja@uhs.nhs.uk.
⁶⁰ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: emily.cornish@uhs.nhs.uk.

PMID: 40857840
DOI: 10.1016/j.vaccine.2025.127597

Free article

Clinical Trial

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: Final results of a phase 2, single-blind, randomised controlled trial (COV006)

Grace Li et al. Vaccine. 2025.

Free article

. 2025 Aug 30:62:127597.

doi: 10.1016/j.vaccine.2025.127597. Epub 2025 Aug 25.

Authors

Collaborators

COV006 trial team:
Robert Aley⁸, Rachel Anslow⁹, Katrina Cathie¹⁰, Rachel Cooper¹¹, Shuo Feng¹², Simon Kerridge¹³, Alice Lelliott¹⁴, Yama Mujadidi¹⁵, Khuen Ng¹⁶, Sarah Rhead¹⁷, Nisha Singh¹⁸, David Smith¹⁹, Karly Tang²⁰, Andy Yao²¹, Ruth Drury²², Emily Lees²³, Helen Ratcliffe²⁴, Matthew Rajan²⁵, Kushalinii Hillson²⁵, Stanislava Koleva²⁶, Jill Muller²⁷, Danielle Woods²⁸, Sophie Davies²⁹, Eva Galiza³⁰, Natalina Sutton³¹, Jennifer J P Pearce³², Cecilia L Hultin³³, Luis de Luna George³⁴, Nicole M M Branch³⁵, Zsofia Danos³⁶, Emily R Beales³⁷, Shari S S Sapuan³⁸, Adam Boon³⁹, Sofia Cuevas-Asturias²⁵, Isabel Rowbotham⁴⁰, Samantha Thomson-Hill⁴¹, Leila Godfrey⁴², Helen Sanders⁴³, Jamie Fowler⁴⁴, Reece Mabbett⁴⁵, Hannah Sharpe⁴⁶, Emma Sheehan⁴⁷, Jeremy Aboagye⁴⁸, Marta Ulaszewska⁴⁹, Amy Flaxman⁵⁰, Daniel R Owens⁵¹, Alasdair P S Munro⁵², Abigail L Oliver⁵³, Jonathan F Baker⁵⁴, Sally Salter⁵⁵, Rachel Brampton⁵⁶, Louise Haskell⁵⁷, Wythehi Ambihapathy⁵⁸, Guneswary Thaygaraja⁵⁹, Cornish L Emily⁶⁰

Affiliations

¹ Oxford Vaccine Group, University of Oxford, UK. Electronic address: g.li@nhs.net.
² Oxford Vaccine Group, University of Oxford, UK.
³ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
⁴ Vaccine Institute, St George's, University of London and St George's University Hospitals NHS Trust, London, UK.
⁵ Bristol Royal Hospital for Children, University of Bristol, Bristol, UK.
⁶ Oxford Vaccine Group, University of Oxford, UK; Chinese Academy of Medical Sciences Oxford Institute, Oxford, UK.
⁷ Oxford Vaccine Group, University of Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK, Oxford, UK.
⁸ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: robert.aley@paediatrics.ox.ac.uk.
⁹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: rachel.anslow@paediatrics.ox.ac.uk.
¹⁰ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: k.cathie@soton.ac.uk.
¹¹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: rachel.cooper@paediatrics.ox.ac.uk.
¹² Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: shuo.feng@paediatrics.ox.ac.uk.
¹³ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: simon.kerridge@paediatrics.ox.ac.uk.
¹⁴ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: alice.lelliott@nhs.net.
¹⁵ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: yama.mujadidi@paediatrics.ox.ac.uk.
¹⁶ Bristol Royal Hospital for Children. Electronic address: khuenfoong.ng@nhs.net.
¹⁷ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: sarah.rhead@paediatrics.ox.ac.uk.
¹⁸ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: nisha.singh@paediatrics.ox.ac.uk.
¹⁹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: david.smith@ndorms.ox.ac.uk.
²⁰ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: karly.tang@paediatrics.ox.ac.uk.
²¹ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: andy.yao@paediatrics.ox.ac.uk.
²² Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: ruth.drury@paediatrics.ox.ac.uk.
²³ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford; Oxford University Hospitals NHS Trust. Electronic address: emily.lees@paediatrics.ox.ac.uk.
²⁴ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: helen.ratcliffe@paediatrics.ox.ac.uk.
²⁵ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford.
²⁶ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: stanislava.koleva@paediatrics.ox.ac.uk.
²⁷ Oxford Vaccine Group, Department of Paediatrics, Churchill Centre for Vaccinology and Tropical Medicine, University of Oxford. Electronic address: jill.muller@paediatrics.ox.ac.uk.
²⁸ Jenner Institute, University of Oxford. Electronic address: danielle.woods@ndm.ox.ac.uk.
²⁹ Jenner Institute, University of Oxford. Electronic address: sophie.davies@ndm.ox.ac.uk.
³⁰ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: egaliza@sgul.ac.uk.
³¹ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: nsutton@sgul.ac.uk.
³² Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: jpearce@sgul.ac.uk.
³³ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: chultin@sgul.ac.uk.
³⁴ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ldelunag@sgul.ac.uk.
³⁵ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: nicole.branch@nhs.net.
³⁶ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: zdanos@sgul.ac.uk.
³⁷ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ebeales@sgul.ac.uk.
³⁸ Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London. Electronic address: ssapuan@sgul.ac.uk.
³⁹ University of Bristol. Electronic address: adam.boon@bristol.ac.uk.
⁴⁰ Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: ir13772@bristol.ac.uk.
⁴¹ University of Bristol. Electronic address: sam.thomson-hill@bristol.ac.uk.
⁴² Jenner Institute, University of Oxford. Electronic address: leila.godfrey@ndm.ox.ac.uk.
⁴³ Jenner Institute, University of Oxford. Electronic address: helen.sanders@ndm.ox.ac.uk.
⁴⁴ Jenner Institute, University of Oxford. Electronic address: jamie.fowler@ndm.ox.ac.uk.
⁴⁵ Jenner Institute, University of Oxford. Electronic address: reece.mabbett@ndm.ox.ac.uk.
⁴⁶ Jenner Institute, University of Oxford. Electronic address: hannah.sharpe@seh.ox.ac.uk.
⁴⁷ Jenner Institute, University of Oxford. Electronic address: emma.sheehan@ndm.ox.ac.uk.
⁴⁸ Jenner Institute, University of Oxford. Electronic address: jeremy.aboagye@ndm.ox.ac.uk.
⁴⁹ Jenner Institute, University of Oxford. Electronic address: marta.ulaszewska@ndm.ox.ac.uk.
⁵⁰ Jenner Institute, University of Oxford. Electronic address: amy.flaxman@ndm.ox.ac.uk.
⁵¹ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: d.owens@soton.ac.uk.
⁵² NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: a.munro@soton.ac.uk.
⁵³ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: abigail.oliver@uhs.nhs.uk.
⁵⁴ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: jonathan.baker@uhs.nhs.uk.
⁵⁵ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: sally.salter@uhs.nhs.uk.
⁵⁶ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: rachel.brampton@uhs.nhs.uk.
⁵⁷ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: louise.haskell@uhs.nhs.uk.
⁵⁸ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: Wythehi.Ambihapathy@uhs.nhs.uk.
⁵⁹ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: guneswary.thaygaraja@uhs.nhs.uk.
⁶⁰ NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust. Electronic address: emily.cornish@uhs.nhs.uk.

PMID: 40857840
DOI: 10.1016/j.vaccine.2025.127597

Abstract

Background: Paediatric COVID-19 vaccination programmes were initiated in response to the coronavirus pandemic declared by the World Health Organisation (WHO) in 2020. Ten COVID-19 vaccines received WHO Emergency Use Listing, however, only five were approved for use in children. ChAdOx1 nCoV-19 (AZD1222) was approved in adults in a two-dose regimen. We previously reported interim findings of a phase 2 study of ChAdOx1 nCoV-19 in children with immunogenicity, comparable with adults. Final results after 12 month follow-up are reported.

Methods: Single-blind, randomised controlled trial across four UK centres, recruiting 261 children and adolescents (aged 6-17 years). Participants received either two doses of ChAdOx1 nCoV-19 or Bexsero vaccine (controls). The primary outcome was safety (adverse events for 28 days following vaccination and serious adverse events throughout), and secondary outcome was immunogenicity (measured by SARS-CoV-2 anti-spike enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immunosorbent spot (ELISpot)).

Findings: Five serious adverse events and four adverse events of special interest were reported. None were related to study vaccinations, and there were no deaths. Geometric mean titres (GMTs) from an anti-spike (Wuhan) ELISA in participants aged 6-11 years were 1 EU/ml (95% CI 1-2) at baseline versus 796 EU (95% CI 161-3948, n =4) at D364. In participants aged 12-17 years, GMTs were 1 EU/ml (95% CI 1-2, n=3) at baseline versus 1432 EU/ml (95% CI 2337-6083; n=6) at D364 (2 dose regimen at 112-day interval), compared to 3 EU/ml (95% CI 0-62) at baseline versus 392 EU/ml (95% CI 24, 6493; n=3) at D364 (2 dose regimen at a 28-day interval).

Interpretation: A two-dose regimen of ChAdOx1 nCoV-19 was immunogenic and safe in the trial population. No vaccine-related serious adverse events were reported. Immune responses persisted to 12 months in participants who did not experience breakthrough infection, This trial was registered with ISRCTN, trial number 15638344.

Funding: The study was funded by the Department of Health and Social Care, through the National Institute for Health Research, and AstraZeneca.

Keywords: Paediatric vaccinology; SARS-CoV-2; Viral vectors.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AJ Pollard as director of Oxford Vaccine Group reports financial support was provided by AstraZeneca Pharmaceuticals LP. AJP is chair of the UK Department of Health and Social Care's Joint Committee on Vaccination and Immunisation but did not participate in policy advice on coronavirus vaccines during the pandemic. He was a member of the WHO Strategic Advisory Group of Experts (SAGE) until 2022. AJP is chief investigator on clinical trials of Oxford University's COVID-19 vaccine funded by NIHR. TL is named as an inventor on a patent application covering the ChAd vaccine and is an occasional consultant to Vaccitech, unrelated to this work. Oxford University has entered into a partnership with AstraZeneca for further development of ChAdOx1 nCoV-19 and AJP, TL, SB, GL are contributors under the licence agreement. MDS acts on behalf of the University of Oxford as an investigator on studies funded or sponsored by vaccine manufacturers, including AstraZeneca, GlaxoSmithKline, Pfizer, Novavax, Janssen, Medimmune, and MCM. He receives no personal financial payment for this work. SNF acts on behalf of University Hospital Southampton NHS Foundation Trust as an investigator or provides consultative advice on clinical trials and studies of COVID-19 and other vaccines funded or sponsored by vaccine manufacturers, including Janssen, Pfizer, AstraZeneca, GlaxoSmithKline, Novavax, Seqirus, Sanofi, Medimmune, Merck, and Valneva. He receives no personal financial payment for this work. PTH acts on behalf of St George's University of London as an investigator on clinical trials of COVID-19 vaccines funded or sponsored by vaccine manufacturers, including Janssen, Pfizer, AstraZeneca, Novavax, Moderna and Valneva. He receives no personal financial payment for this work. All other authors declare no competing interests. AstraZeneca reviewed the final manuscript before submission, but the authors retained editorial control. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: Final results of a phase 2, single-blind, randomised controlled trial (COV006)

Collaborators

Affiliations

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: Final results of a phase 2, single-blind, randomised controlled trial (COV006)

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous