nCoV: Rapid Clinical Development of ChAdOx1 nCoV-19

Lead Research Organisation: University of Oxford
Department Name: UNLISTED

Abstract

ChAdOx1 is a safe and effective vaccine vector that can be used to produce vaccines
against many different diseases. Unlike other rapid vaccine technologies, only a single
dose of the vaccine is likely to be needed. DNA, mRNA and recombinant protein vaccines
typically require two or three doses to achieve protective immunity. ChAdOx1 has been
used to make a Middle East Respiratory Syndrome Coronavirus vaccine which is
protective in non-human primates after a single dose, and is safe and highly immunogenic
in humans as demonstrated in a phase I clinical trial. The same vaccine design has been
followed to produce ChAdOx1 nCoV. We now propose to manufacture this vaccine to
cGMP and conduct a clinical trial in healthy volunteers in the UK. We will work closely with
the MHRA to complete all required testing of the vaccine and obtain regulatory approval in
as short a time as possible, with the aim of initiaiting the clinical trial in June.
We will also work with partners to demonstrate protective efficacy of ChAdOx1 nCoV in
two different animal models. This will provide the necessary information to support further
clinical trials of this vaccine to demonstrate efficacy in humans.

Technical Summary

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project.

ChAdOx1 is a replication-deficient simian adenoviral vector that provides a platform
technology for the production of vaccines against many infectious diseases. For Middle
East Respiratory Syndrome (MERS) coronavirus, a single dose of the ChAdOx1-vectored
MERS vaccine resulted in protection against MERS challenge in non-human primates and
the induction of strong humoral and T cell responses in a Phase I clinical trial. The same
vaccine design has now been followed to produce ChAdOx1 nCoV. Preclinical studies of
the vaccine will be initiated by the end of February. This will include demonstration of
vaccine immunogenicity (antibody and T cell) in mice, followed by vaccine immunogenicity
and efficacy against nCoV-19 challenge in ferrets and non-human primates with
collaborators at PHE Porton Down and NIH. A pre-GMP vaccine seed stock is in
production at Oxford’s GMP manufacturing facility, and will be provided to Advent, Italy,
which will produce the first 1000 doses for clinical studies.
In parallel with preclinical studies and vaccine manufacturing, Oxford will work with the
MHRA on a rapid release testing package. This will employ deep sequencing of the Cell
Harvest and Drug Substance to identify any potential replication competent adenovirus
and adventitious agents rather than following the existing set of in vivo and in vitro assays,
greatly reducing the time to cGMP certification. A phase I/II clinical trial will then be
undertaken to demonstrate vaccine safety and immunogenicity in adults, older adults and
children.

Publications

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Dejnirattisai W (2021) Antibody evasion by the P.1 strain of SARS-CoV-2. in Cell

 
Description Meeting with Andrew Mitchell MP Minister for Development and Africa and FCDO staff
Geographic Reach Multiple continents/international 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
URL https://www.devex.com/news/minister-promises-to-act-as-experts-raise-alarm-over-uk-pandemic-readines...
 
Description Member of Joint Committee on Vaccination and Immunisation
Geographic Reach National 
Policy Influence Type Participation in a guidance/advisory committee
Impact The JCVI advises the UK government on vaccine strategy and roll out.
 
Description COV19 OxfordVacc-01
Amount £31,179,621 (GBP)
Funding ID COV19 OxfordVacc-01 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2020 
End 03/2022
 
Description nCoV: Rapid Clinical Development of ChAdOx1 nCoV-19
Amount £2,174,847 (GBP)
Funding ID MC_PC_19055 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 03/2020 
End 09/2021
 
Description PHE 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution Sharing protocols.
Collaborator Contribution Same.
Impact Ongoing.
Start Year 2019
 
Title ChAdOx1 nCoV-19/AZD1222 
Description ChAdOx1 nCoV-19, initially supported by VaxHUb, has been in clinical trials in UK, SA, Brazil, Kenya, US, licensed in 60 countries for emergency use 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Wide-scale adoption
Year Development Stage Completed 2020
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Demonstrated unprecedented speed of platform response. 
URL https://www.isrctn.com/ISRCTN15281137?q=ChAdOx1%20nCoV-19&filters=&sort=&offset=5&totalResults=5&pag...
 
Description 18th International Congress of Immunology Cape Town South Africa - Keynote Lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact 18th International Congress of Immunology Cape Town South Africa attendance Nov 27th- Dec 2nd 2023 and Keynote lecture on Development of Vaccines against Outbreak Pathogens enabling discussions with a wide variety of colleagues.
Year(s) Of Engagement Activity 2023
URL https://iuis.org/events/iuis-2023/
 
Description 2023 ISV Congress Chair - Next Generation Vaccines - 22-24 October 2023 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Chaired a Congress session at the 2023 International Society for Vaccines Annual meeting on Next Generation Vaccines, Lausanne Switzerland on 23rd October 2023. Participated in the congress 22-24 October 2023 engaging in discussions, with peers, industry professionals and students.
Year(s) Of Engagement Activity 2023
URL https://isvcongress.org/node/217
 
Description ATOM Festival Abingdon 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Interactive science festival stand focused on how vaccines are made
Year(s) Of Engagement Activity 2022
 
Description Adam Sweeting Lecture - University of Surrey- Preparing for Pandemic Vaccine Development - 18th May 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Participated in the Adam Sweeting Lecture series at the University of Surrey giving a talk on Preparing for Pandemic Vaccine Development on 18th May 2023. Answered questions afterwards and engaged in discussions of the topic with colleagues and other audience members. Attended a dinner with invited guests to continue discussions.
Year(s) Of Engagement Activity 2023
URL https://www.surrey.ac.uk/events/20230518-preparing-pandemic-vaccine-development
 
Description Advisory Board for World Innovation Summit for Health 2022 report on A new era for vaccine innovation - Doha Qatar 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Participation in the WISH event in Doha Qatar and active engagement as part of an Advisory group considering what we've learned thus far in order to prepare for future pandemic threats. A report was produced from discussions examining three main areas: the factors, enablers, and challenges of COVID-19 vaccine development; issues of access, equity and justice in vaccines and vaccination; and how lessons learned from COVID-19 vaccine development, production and deployment can be applied to other diseases.
Year(s) Of Engagement Activity 2022
URL https://wish.org.qa/reports/a-new-era-for-vaccine-innovation/
 
Description All-Party Parliamentary Group on Medical Research 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Aims of the event
a) To bring Parliamentarians together with scientists and other life sciences sector representatives to recognise the exceptional efforts that have been made.
b) To inform Parliamentarians of how decades of funding and support enabled the UK's broad and diverse medical research base to quickly pivot to tackle the pandemic.
c) To highlight to Parliamentarians the importance of stable and sustainable long-term funding in a diversity of research fields, infrastructures, and research workforces to tackle current and future health challenges across the UK and internationally.
Year(s) Of Engagement Activity 2022
 
Description Andrew Marr via BBC 7Feb2021 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Impact unknown but reached a large audience.
Year(s) Of Engagement Activity 2021
URL https://www.bbc.co.uk/programmes/p09699wz
 
Description BBC Panorama Oxford COVID vaccine documentary 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact The inside story of the development of the Oxford vaccine against Covid-19. Fergus Walsh scrutinises the data that has come out of the trials, and examines the vaccination's efficacy and safety.
Year(s) Of Engagement Activity 2020
URL https://www.bbc.co.uk/iplayer/episode/m000qdzd/panorama-the-race-for-a-vaccine
 
Description Cheltenham Science Festival Maker Shack 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact The Maker Shack at Cheltenham Science festival encourages interactive science engagement with a 'making theme'. Our 'Vaccine Maker' activity showcased how different vaccines including the Oxford Covid Vaccine were made.
Year(s) Of Engagement Activity 2022
URL https://www.youtube.com/watch?v=GLGDG6tbUR4
 
Description Cheney School Vaccine Hesitancy Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact A 2 hour interactive workshop testing new strategies for discussing vaccine hesitancy with secondary school pupils at the local Cheney School.
Year(s) Of Engagement Activity 2022
 
Description Coalition for Global Prosperity Future Leaders Conference Speaker - The UK as a Health and Science 'Superpower' - 8th September 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Coalition for Global Prosperity Future Leaders Conference Speaker - The UK as a Health and Science 'Superpower' - 8th September 2023 - Ditchley Park , UK - spoke about science as a collective endeavour and short-termism in the science community. Also held discussions with other invitees over coffee breaks and lunch on related topics.
Year(s) Of Engagement Activity 2023
URL https://www.coalitionforglobalprosperity.com/ditchley-park-retreat
 
Description Dhaka Literary Festival 2023, Bangladesh 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Participated in Women in Science section with Prof Hasina Khan and Prof Yasmeen Haque moderated by Dr Senjuti Saha and Science Vaxxers with Sadaf Saaz.
Year(s) Of Engagement Activity 2023
URL https://www.dhakalitfest.com/2023
 
Description Doherty Institute Media Conference - Melbourne 27th September 2023 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Discussion on COVID-19 - challenges, lessons learnt and where to next - in a media conference hosted by Melbourne Laureate Professor Sharon Lewin, Director of the Doherty Institute.
Year(s) Of Engagement Activity 2023
URL https://www.doherty.edu.au/news-events/news/covid-19-vaccines-with-special-guest-professor-dame-sara...
 
Description Elizabeth Blackwell Institute Annual Public Lecture - 6th October 2021 - hosted by University of Bristol 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Invited to give the Annual Elizabeth Public lecture on developing the Oxford AstraZeneca Covid-19 vaccine - held online hosted by the University of Bristol on 6th October 2021
Year(s) Of Engagement Activity 2021
URL https://www.bristol.ac.uk/alumni/events/2021/elizabeth-blackwell-institute-lecture.html
 
Description Franco-British Young Leaders Seminar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact The Oxford Covid Vaccine team hosted the Franco-British Young Leaders for a seminar and tour of the Oxford labs.
Year(s) Of Engagement Activity 2022
URL https://francobritish.org/en/young-leaders/
 
Description History of Science Museum - Vaccines study days 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact A series of now bi-yearly events in collaboration with the History of Science Museum including talks on the the development of the Oxford Covid Vaccine, Vaccine Hesitancy workshops and meet the researcher opportunities for local GCSE and A Level students.
Year(s) Of Engagement Activity 2022
 
Description Infection Prevention Society- 15th Annual Conference - Preparing for Pandemic Vaccine Development Talk - 19th October 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk at the Infection Prevention Society Conference in Liverpool on 19th October 2023 followed by discussions with professionals, industrialists and other colleagues.
Year(s) Of Engagement Activity 2023
URL https://www.ips.uk.net/education-and-events
 
Description Invited Speaker to Master Course in Vaccinology and Drug Development- Siena, Italy - 6th-8th June 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Talk on Outbreak Pathogens at the Pandemic Sciences Institute and Oxford Vaccine group in collaboration with Prof. Teresa Lambe at the Master Course in Vaccinology and Drug Development- Siena, Italy - 6th-8th June 2023.
Year(s) Of Engagement Activity 2023
 
Description Keynote Panel Member - World Vaccine Congress- Barcelona October 17th 2023 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Participation in Keynote Panel: Getting ahead of the curve on pandemic preparedness discussing:
-The evolution of COVID and the consequent role of current and next generation vaccines
-How can we shorten/lower the epidemic curve rather than responding to and maintaining population immunity?
-How can we most efficiently extrapolate the lessons from COVID to other priority pathogens of pandemic potential?
-Where are the remaining vulnerabilities in the system and how can we better mitigate these for better pandemic preparedness?

Moderated by Prof Isabel Oliver, Chief Scientific Advisor Transition Lead, UK Health Security Agency. with participation by EC, Moderna and CEPI

Additionally participated in a vaccine safety discussion on ViTT, myocarditis & pericarditis: what are the next steps? 16th October 2023 and engaged with other Congress participants in attendance.
Year(s) Of Engagement Activity 2023
 
Description Oxford University Alumni Network Victoria Dinner Presentation -Melbourne - 22nd September 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Supporters
Results and Impact Reception and dinner talk given on vaccine development and chatted with members of the public and supporters participating in discussions and answering questions.
Year(s) Of Engagement Activity 2023
URL https://www.ousv.org/event-5368753
 
Description Participation in Southeast Asia initiative to combat SARS-CoV-2 variants (SEACOVARIANTS) Meeting, Bangkok, Thailand, 28th - 29th January 2024 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact Discussion of plans for the multidisciplinary research platform - Southeast Asia initiative to combat SARS-CoV-2 variants (SEACOVARIANTS), 2022-2025 in Bangkok, Thailand, 28th - 29th January 2024
Year(s) Of Engagement Activity 2024
URL https://www.oucru.org/project/seacovariants/
 
Description Scaling Up Scotland Conference 3rd November 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Industry/Business
Results and Impact Scaling up Scotland Conference and Networking Event 3rd November 2023. Talk on development of the ChAdOx1 Covid-19 vaccine and networking with entrepreneurs.
Year(s) Of Engagement Activity 2023
URL https://www.thehunterfoundation.co.uk/scaling-up-scotland-major-conference-and-networking-event-laun...
 
Description Supporting Women in MDHS (SWiM) Inspiring Stories Covid-19 Vaccine Development 27th September Doherty Institute 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Telling the story of developing a new vaccine from scratch-in less than a year-including the logistical, regulatory, and technical issues involved. Prior to COVID-19, my team designed vaccines against Ebola, Mers and influenza, and used the same vaccine platform technology to create our COVID-19 vaccine.

The conversation also covered early career interests and motivations, the development of the vaccine during the pandemic, the field of vaccine research since COVID-19, and how we prepare for the challenges ahead.
Year(s) Of Engagement Activity 2023
URL https://paedacademy.medicine.unimelb.edu.au/events/3505
 
Description Talk and Panel Discussion at International Society for Influenza and other Respiratory Virus Diseases- Seattle USA 1-3 March 2023 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Panel discussion on How can correlates of protection help the regulatory process for Licensure of New Vaccines. Talk on Lessons learned from new COVID vaccines at the International Society for Influenza and other Respiratory Virus Diseases held Seattle USA 1-3 March 2023 followed by discussions with colleagues, funding organisations and other participants.
Year(s) Of Engagement Activity 2023
URL https://www.isirv.org/site/images/conferences/Correlates_Seattle/Final%20Programme%2016%20February%2...
 
Description UK Pandemic Sciences Network Meeting- 5th-6th September 2023 Liverpool- Panel Member Science Communication in a Pandemic 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Participation in the UK Pandemic Sciences Network Meeting - From Regional, to National, To Global Resilience, 5th-6th September 2023, The Spine- Liverpool including a panel on Science Communication in a Pandemic with Fergus Walsh of the BBC and discussions with relevant pandemic preparedness scientists, media and officials.
Year(s) Of Engagement Activity 2023
URL https://news.liverpool.ac.uk/2023/09/08/liverpool-welcomes-uks-top-pandemic-scientists/
 
Description Vaccines Bioprocess Development and Commercialisation Workshop -13-15 June 2023- MIT, Cambridge MA, USA 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Gave a talk on the development of the Oxford AstraZeneca Covid-19 vaccine and participated in an expert panel on Accessibility and Platformability at the Vaccines Bioprocess Development and Commercialisation Workshop -13-15 June 2023 hosted by MIT in Cambridge MA, USA. Also participated in discussions with industrialists, funders and other scientific colleagues.
Year(s) Of Engagement Activity 2023
URL https://www.masslifesciences.com/event/vaccines-bioprocess-development-commercialization-workshop/
 
Description Wychwood School Medical Chemistry Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Support for the local school conference with recorded Keynote introduction from Prof Sarah Gilbert. Promoting the idea that vaccine development and manufacture is a multidisciplinary subject.
Year(s) Of Engagement Activity 2022
 
Description Wycliffe College: Primary School STEM Day 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact STEM focused interactive activity day for primary school aged children. The event was hosted by a high school with students taking the role as science facilitators, supported by scientists. Theme was vaccine research.
Year(s) Of Engagement Activity 2022
 
Description mRNA 3rd Scientific Colloquium on vaccine access and equity on the African continent - Keynote address Assessing Impact of access to mRNA vaccines in LMICs 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Third sector organisations
Results and Impact mRNA 3rd Scientific Colloquium on vaccine access and equity on the African continent meeting hosted by Afrigen Biologics 27th November 2023 - Keynote address Assessing Impact of access to mRNA vaccines in LMICs. Followed by questions and discussions with participating scientists, policy makers and industrialists.
Year(s) Of Engagement Activity 2023
URL https://www.afrigen.co.za/2023/11/29/mmrna-scientific-colloquium-on-vaccine-access-and-equity-on-the...