Clinical Vaccine Development and Biomanufacturing

Course summary

Clinical Vaccine Development and Biomanufacturing


This course has been developed in close collaboration with leading clinicians, veterinarians and industrial partners who conduct clinical trials.

The course is designed as a stand-alone module or can be taken as an add-on to the Human and Veterinary Vaccinology module.

The course aims to provide:

  • An overview of pre-clinical testing and the pathway from pre-clinical testing to field trials.
  • A more detailed discussion of vaccine immunogenicity, testing vaccine immunogenicity in the field and the need for correlates of immune protection. The different phases of vaccine testing from Phase I to IV.
  • An overview of the development of veterinary vaccines.
  • An introduction to the principles and conduct of Good Clinical Practice.


The Vaccine Biomanufacturing section of this course will be designed in close collaboration with our industrial partners to provide:

  • An overview of vaccine markets and growth drives for developed and developing settings.
  • An overview of the biomanufacturing processes used for the production of a spectrum of vaccines.
  • The principles of GMP (Good Manufacturing Practice) and how these are applied to vaccine production.
  • An introduction to Quality Assurance and the use of molecular methods to verify quality.


The Programme provides state-of-the-art teaching in both human and veterinary vaccinology, drawing on the experience of Oxford University, the world-renowned Jenner Institute based in Oxford and our partners in industry.

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Experts from Oxford University and industry will be invited to provide lectures and lead discussion sessions.

There are now two courses in the Vaccinology Programme (including this course):

Programme details

Note that this is a draft timetable and may be subject to change.

Day 1


  • 09:00 – 09:30: Introductions from the course participants
    Dr Rebecca Ashfield, Senior Project Manager, The Jenner Institute, University of Oxford

  • 09:30 – 10:15: Course introduction
    Prof Adrian Hill, Director, The Jenner Institute, University of Oxford

  • 10:15 – 10:45: Introduction to vaccine types
    Dr Rebecca Ashfield, Senior Project Manager, The Jenner Institute, University of Oxford

  • 10:45 – 11:15: Coffee break

  • 11:15 – 12:15: Taking lab discoveries into manufacture
    Dr Sarah Gilbert, Professor of Vaccinology, Programme Director for Wellcome Trust Strategic Award on Human and Veterinary Vaccine Development, The Jenner Institute, University of Oxford
  • 12:15 - 13:30: Lunch
  • 13:30 – 14:30: Regulatory aspects for manufacturing
    Dr Richard Tarrant, Quality Control Manager at Clinical Biomanufacturing Facility (CBF), University of Oxford

  • 14:30 – 15:30: Introduction to GMP upstream and downstream processes
    Dr Tarit Mukhopadhyay, Senior Lecturer, UCL, and Chair of the Vaccine Development Working Group for the UK Vaccine Network 

  • 15:30 - 16:15: Coffee break

  • 16:15 - 17:15: Flu vaccine manufacture and clinical development
    Dr Matthew Downham, Associate Director - Manufacturing Science & Technology, Medimmune UK Ltd

Day 2


  • 09:00 – 10:30: Case study (influenza vaccine planning)
    Dr Matthew Downham, Associate Director - Manufacturing Science & Technology, Medimmune UK Ltd
  • 10:30 – 11:00: Coffee break

  • 11:00 – 12:15: Development of large-scale manufacturing processes for modern live-viral vaccines: Smallpox, Japanese Encephalitis and Dengue Fever
    Dr Daniel Vellom, Senior Director, Global Technology Innovation, Sanofi Pasteur

  • 12:15 – 13:15: Clinical development overview
    Dr Matthew Snape, Consultant in Vaccinology and General Paediatrics, Oxford University Hospitals NHS Trust and Honorary Senior Clinical Lecturer, University of Oxford

  • 13:15 – 14:30: Lunch

  • 14:30 – 15:30: First time in man: Moving from the bench to the clinic with HIV vaccine candidates
    Dr Lucy Dorrell, Senior Clinical Lecturer, Honorary Consultant in GUM/HIV, The Jenner Institute, University of Oxford

  • 15:30 – 16:00: Coffee break

  • 16:00 – 17:00: Statistical considerations when designing a clinical trial
    Ms Ly-Mee Yu, Senior Medical Statistician, Department of Primary Health Care Sciences, University of Oxford

Day 3


  • 09:00 – 11:15: Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford

  • 11:15 - 11:45: Coffee break

  • 11:45 – 12:45: The Importance of post-vaccination surveillance. Case study: Bacterial Meningitis
    Dr Matthew Snape, Consultant in Vaccinology and General Paediatrics, Oxford University Hospitals NHS Trust and Honorary Senior Clinical Lecturer, University of Oxford

  • 12:45 – 13:45: Lunch

  • 13:45 - 15:15: Immune monitoring and immune correlates with reference to early Phase clinical trials in Malaria and Ebola
    Dr Katie Ewer, Senior Immunologist for Ebola and pre-erythrocytic malaria vaccine trials, Jenner Institute, University of Oxford

  • 15:15 - 15:30: Coffee break
  • 15:30 - 16:30: Designing and coordinating large, multi-centre, Phase III clinical trials: case study 'Rotavirus and HPV - safety and efficacy vaccine trials'
    Dr Otavio Cintra, Scientific Affairs and Public Health Director, GSK Vaccines

Day 4


  • 9:15 - 10:15: Clinical trials: preparing for trials in developing countries
    Dr Amanda Rojek, Epidemic diseases Research Group Oxford (ERGO) at the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford.

  • 10:15 - 11:15: Adjuvants for vaccines in clinical trials
    Dr Mike Whelan

  • 11:15 – 11:45: Coffee break

  • 11:45 – 12:45: Regulatory aspects on vaccine marketing authorisations in European Union
    Dr Manuela Mura, Scientific officer, Anti-infectives and Vaccines, European Medicines Agency

  • 12:45 – 14:00: Lunch

  • 14:00 – 15:30: Ethical considerations for trials in developing countries
    Dr Mark Sheehan, Biomedical Research Centre Ethics Fellow, The Ethox Centre and James Martin Research Fellow, Institute for Science & Ethics, University of Oxford
  • 15:30 - 15:40: Closing session / feedback



The above content may be subject to minor revision.



Participants who attend the full course will receive a Certificate of Attendance. The sample shown is an illustration only and the wording will reflect the course and dates attended.


Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.


Standard course fee: £1295.00


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Dr Rebecca Ashfield


Senior Project Manager, The Jenner Institute, University of Oxford

Rebecca Ashfield gained a first degree in Biochemistry and DPhil in molecular biology, both from Oxford University.

She carried out post-doctoral research into regulation of gene transcription and Type II Diabetes, and was awarded junior research fellowships by Magdalen College and Worcester College Oxford.

Dr Ashfield then worked for 12 years as a project and collaborations manager at Immunocore Ltd, a biotechnology company making protein therapeutics for cancer immunotherapy, and joined the Jenner Institute in 2013 as a senior project manager for pre-clinical malaria, working with Professor Adrian Hill.

Dr Otavio Augusto Leite Cintra


Scientific Affairs and Public Health Director, GSK Vaccines

Dr Cintra joined GSK in 2008 as Brazil Medical Manager having had a long and prestigious career within pediatrics and infectious diseases. He graduated in 1989 from University of Sao Paulo School of Medicine at Ribeirao Preto and was trained in Paediatrics and Paediatrics Infectious Diseases. He is board certified by the Brazilian Society of Pediatrics. His Masters came in 1998 and his PhD in 2002 focused upon RSV and other respiratory viruses. He has been a visiting professor to Baylor and Virginia school of medicine; he was also Professor of pediatrics and has acted as principal investigator in various clinical trials, epidemiological and health economic studies. He has advised the Brazilian Ministry of Health on respiratory viruses and has had many peer reviewed articles, book chapters and abstracts as well as speaking activities at conferences. After having different roles in GSK Brazil and Latam, he is presently Scientific Affairs and Public Health Director, GSK Vaccines Global Medical Affairs.

Dr Lucy Dorrell


Senior Clinical Lecturer, Honorary Consultant in GUM/HIV, The Jenner Institute, University of Oxford

Lucy Dorrell obtained a Bachelor of Medicine from the University of Southampton in 1988. After junior hospital posts during which she obtained MRCP, she began her research career in 1993 as a Clinical Research Fellow in Communicable Diseases and Genitourinary Medicine at Imperial College, London with Professor Jonathan Weber.

She was awarded a DM degree in 1998 from the University of Southampton for her research into antigen-presenting cell function in HIV infection. She was subsequently awarded an MRC Clinical Training Fellowship to study immunological mechanisms of resistance to HIV-1 and HIV-2 under Professor Sarah Rowland-Jones at MRC Laboratories, The Gambia and at the Weatherall Institute of Molecular Medicine. In 2000 she was awarded an MRC Clinician Scientist Fellowship, which she took up in 2002 after completing clinical specialist training and obtaining a CCST in HIV/GUM.

With Professor Andrew McMichael she set up a programme of translational research evaluating therapeutic immunisation in HIV-1 infection with novel DNA and modified vaccinia virus Ankara-vectored HIV-1 vaccines developed at MRC Human Immunology Unit. She was awarded a HEFCE Clinical Senior Lectureship in 2007.

Her research team is conducting further clinical therapeutic vaccination studies while also investigating mechanisms which determine success or failure of host immune control of HIV.

Dr Matthew Downham


Associate Director, Manufacturing Science and Technology department, Medimmune UK Ltd

Dr Downham studied for a bachelor of sciences degree (with honours) in industrial biology at London South Bank Polytechnic (UK) which included a placement with Boehringer Mannheim, now Roche (Germany). He then completed a PhD in biochemical engineering (Birmingham University, UK), a post-doctoral fellowship in bio-molecular sciences (Liverpool John Moores University, UK) and a post-graduate certificate in further/higher education (Bolton Institute, UK).

He joined the biopharmaceutical industry in 1997 and has worked for Protherics (UK), Bavarian Nordic (Germany), Morphosys (Germany) and, Novartis Vaccines and Diagnostics (Italy). Throughout this time Dr Downham worked on the pre/non-clinical and early clinical development of either vaccine, antibody or enzyme therapies for a number of infectious, hypertension, inflammatory and oncology indications. He became a European Registered Toxicologist (in 2010) and has co-authored 29 publications/abstracts and 3 international patents.

Dr Downham joined the influenza vaccine franchise of AstraZeneca/Medimmune (UK) in February 2013 as an Associate Director and currently heads the Manufacturing Science and Technology department.

Dr Katie Ewer


Senior Immunologist, The Jenner Institute, University of Oxford

Dr Katie Ewer qualified as a Biomedical Scientist in 2000 at the microbiology department of the John Radcliffe Hospital before joining the University of Oxford as a Research Assistant. She gained a PhD in Immunology in 2004 through The Open University for her work with Dr Ajit Lalvani in the Nuffield Department of Clinical Medicine on novel diagnostic tools for tuberculosis. In 2004, she joined VLA (now AHVLA) and managed the roll-out of interferon-gamma-based diagnosis for bovine TB in the UK herd for DEFRA as well as undertaking research to study immune correlates of protection for TB vaccines in cattle.

Katie joined the Jenner Institute as a Senior Immunologist in 2008 and co-ordinates immunogenicity testing for pre-erythrocytic malaria and Ebola vaccine trials in Oxford and at field sites in East and West Africa. Her work focusses on describing immune responses to viral vectored vaccines in adults and children, identifying vaccine-induced immune correlates of protection and transcriptional profiling of responses to malaria and Ebola vaccines.

Prof Sarah Gilbert


Professor of Vaccinology, Programme Director for Wellcome Trust Strategic Award on Human and Veterinary Vaccine Development, The Jenner Institute, University of Oxford

After a first degree in Biological Sciences at the University of East Anglia, specializing in Microbiology, and a PhD on lipid metabolism in the Biochemistry Department at the University of Hull, Prof Gilbert worked on pentose metabolism in brewing yeasts at the Brewing Research Foundation in Surrey. This led to a research post at the Leicester Biocentre, using molecular biology techniques to study heterologous protein expression in yeast. Prof Gilbert spent four years at Delta Biotechnology in Nottingham, working on production of recombinant human blood proteins in yeast before moving to Adrian Hill’s group at the University of Oxford in 1994.

Prof Gilbert’s chief research interest is the development of vaccines that work by inducing strong and protective T cell responses. This has included work on DNA vaccines and virus-like protein particles carrying multiple T cell epitopes on their surface, as well as the viral vaccine vectors Modified Vaccinia virus Ankara (MVA), fowlpox and adenovirus.

Following the discovery that heterologous prime-boost immunisation, in which the same antigen is delivered in first one vector and then another, is highly immunogenic in pre-clinical studies, she designed antigen inserts for, and produced DNA, MVA and fowlpox vaccines which were then manufactured for clinical trials in both the malaria and tuberculosis vaccine clinical programmes.

More recently Prof Gilbert has begun to apply the same principles of vaccine development, pre-clinical and clinical testing to new vaccines against influenza. The currently available ‘flu vaccines work by inducing antibodies to highly variable surface proteins of the virus, and slightly different versions have to be manufactured each year to keep up with changes in the virus. However the internal proteins of the ‘flu virus, which are produced inside infected cells, are well conserved, not only from one year to the next, but also between seasonal ‘flu viruses and those normally found only in avian species. Using these antigens, it should be possible to make a vaccine that protects against all subtypes of influenza, and ultimately, to stop a new pandemic in its tracks.

Prof Adrian Hill


Director, The Jenner Institute, University of Oxford

Principal areas of research: Malaria vaccines, vectored vaccine development, immunogenetics of infectious disease susceptibility

Adrian Hill trained in medicine at Trinity College Dublin and the University of Oxford, qualifying in 1982. He undertook a DPhil with Sir David Weatherall and John Clegg at the MRC Molecular Haematology unit on the molecular population genetics of thalassaemia in Pacific Islanders. Following further clinical posts in London he returned to the newly opened Institute of Molecular Medicine in 1988 to study genetic susceptibility to malaria as a Wellcome Trust Senior Fellow. In 1995 he was awarded a Wellcome Trust Principal Research Fellowship and in 1996 the title of Professor of Human Genetics. He participated in the founding of the Wellcome Trust Centre for Human Genetics in 1994, and in 2003 co-founded the Oxford Centre for Clinical Vaccinology and Tropical Medicine, which he now chairs. In 2004 he participated in the restructuring of the Edward Jenner Institute for Vaccine Research and in 2005 was appointed director of the new Jenner Institute. He is a Fellow of the Royal College of Physicians, of Magdalen College, Oxford, and of the UK Academy of Medical Sciences.

Tarit Mukhopadhyay


Senior lecturer, Department of Biochemical Engineering, University College London

Tarit is a senior lecturer in the Department of Biochemical Engineering at University College London. For the past ten years he has been working in the field of vaccine bioprocess development on a range of bacterial and virus vaccines. His early work with the Health Protection Agency, involved working on a novel Meningitis B vaccine and the UK licensed Anthrax vaccine.

Since then his research targets include the upstream and downstream processing of conjugate vaccines and virus vectors such as adenovirus, AAV and lentivirus. These include thermo-stable formulation of lentiviruses, novel chromatographic separation techniques for AAV and high-cell density production of adenoviruses.

In 2014, Tarit joined the EU funded (FP7) FLUTCORE consortium to utilise virus like particles to create a universal influenza vaccine expressed in Pichia pastoris. The idea is to create a platform manufacturing process that is independent of antigen switching.

A main focus of his research is scale-down and scale-up. The primary methodology is to create scale-down models that mimic the processing environment to determine CQA/CPP that can be accurately applied to the commercial scale. The obvious benefits of this are reducing time to market and cost.

Dr Manuela Mura


Scientific officer, Anti-infectives and Vaccines, Scientific and Regulatory Management Department, European Medicines Agency

Dr Manuela Mura obtained her degree in veterinary medicine in 2000 in Italy, followed by a PhD in molecular biology conducted in the USA, which focused on the interplay between endogenous non-pathogenic retroviruses and exogenous carcinogenic retroviruses in sheep. Dr Mura continued her virology studies for further 6 years as a post-doc at the University of Glasgow and at Imperial College London in the UK focusing respectively on retroviruses and influenza viruses. Since 2010 she is a scientific officer at the European Medicines Agency in the section of Anti-infectives and Vaccines, involved in the authorisation process of vaccines.

Dr Mark Sheehan


Biomedical Research Centre Ethics Fellow, The Ethox Centre and James Martin Research Fellow, Institute for Science & Ethics, University of Oxford

Mark Sheehan is Oxford Biomedical Research Centre (BRC) Ethics Fellow at the Ethox Centre and a James Martin Research Fellow in the Institute for Science and Ethics. He received his PhD in Philosophy from The City University of New York, where his PhD thesis was on the nature of moral judgements. Prior to his PhD, he received an MA (Hons) and a BA (Hons)/BSc from the University of Melbourne. Prior to coming to Oxford he was a lecturer in the Centre for Professional Ethics at Keele University, Ethics Fellow at the Mt. Sinai Medical School, New York and Adjunct Lecturer in the Philosophy Department at The City College of New York.

As BRC Ethics Fellow, Mark is involved in Research Ethics and Patient and Public Involvement (PPI) across the Oxford NIHR BRC themes. This involvement includes discussions with researchers about research ethics issues in their work, collaborating on research proposals with ethical components and conducting research on issues in research ethics, ethics generally and PPI that engage with the research themes within the BRC. As a member of the Institute for Science and Ethics, Mark is involved in research identifying and critically analysing ethical issues and problems arising in stem cell science, cloning, artificial reproduction and genetics.

The Institute is part of the Oxford Martin School and so he is also involved in a number of collaborations with other parts of the School. Mark has set up and teaches (with the considerable help of colleagues) a series of sessions on research ethics aimed at researchers in the Medical Sciences Division and at the Oxford Radcliffe Hospital. From Hilary term 2011 he will lead (again with the help of colleagues) a seminar series in the Centre for Doctoral Training in Healthcare Innovation in the Institute for Biomedical engineering on the ethics and biotechnology. He also teaches Medical Ethics and Law to the Graduate Entry Medical students at the Medical School and lectures on the Medical Law and Ethics course in the Law School. He has published in such journals as the Journal of Applied Philosophy, the Journal of Medical Ethics, the Cambridge Quarterly on Healthcare Ethics and the American Journal of Bioethics. With colleagues from the Centre for Professional Ethics at Keele University, he has just completed an EU-funded textbook on research ethics. He is a member of the Advisory Group for National Specialised Services (AGNSS) and the Thames Valley Priorities Forum (MOBBB) for the South Central Strategic Health Authority. He also sits on the University’s Social Sciences and Humanities Inter-Divisional Research Ethics Committee and is an external member of the Goldsmith’s Research Ethics Committee. He is a Senior Research Fellow in Philosophy at St. Benet’s Hall.

Current Research Themes: 1.Research Ethics and Governance 2.Ethics and Reproductive Technologies 3.Ethical issues in Resource Allocation 4.Commercialisation and Health 5.Methodology in Applied Ethics and Bioethics

Dr Matthew Snape


Consultant in Paediatrics and Vaccinology, NIHR Oxford Biomedical Research Council & Oxford University Hospitals NHS Trust

Dr Matthew Snape is a consultant in General Paediatrics and Vaccinology at the Oxford University Hospitals NHS trust and an Honorary Senior Clinical Lecturer at the University of Oxford. After completing basic training in paediatrics at the Royal Children's Hospital, Melbourne, he worked in the paediatric intensive care unit at St Mary's Hospital, London. While caring for children suffering overwhelming infections he developed an interest in the prevention of these illnesses by immunisation. This led him to the Oxford Vaccine Group, part of the University of Oxford, Department of Paediatrics, where he has undertaken paediatric clinical trials of meningococcal, pneumococcal, influenza and Hepatitis B vaccines. Dr Snape is partially funded by the Oxford Partnership Comprehensive Biomedical Research Centre.

Dr Daniel Vellom


Senior Director, Global Technology Innovation, Sanofi Pasteur

Dr Daniel Vellom is a Senior Director at Sanofi Pasteur Biologicals involved as a biotechnology expert with Sanofi’s Global Technology Innovation Strategy Group.

Prior to joining Sanofi Pasteur, Dr Vellom worked for seven years at Acambis as the Senior Director of Process Development and prior to that he was a Senior Manufacturing Specialist for Wyeth Vaccines.

Dr Vellom has a PhD in Biochemistry from the University of California, San Diego, and he held an assistant professorship in Chemistry at the City University of New York.

Dr Mike Whelan


Vaccine Developer

Mike is a BSc Biochemist and then completed his PhD in Immunology at the Royal London Hospital. Post-doctoral study at the Institute for Animal Health (IAH) focused in investigating CTL responses in horses infected with Equine Herpesvirus 1. This was then followed by working as a post-doctoral scientist at The Edward Jenner Institute for Vaccine Research examining the immune activation of dendritic cells and their role in defining TH1/TH2 immune responses.

Mike then moved over into industry and spent seven years as Head of Research at Onyvax Ltd. This company was developing allogeneic whole cell vaccines for cancer. Mike’s team was involved in both pre-clinical proof of concept studies, and then the examination of samples from both Phase I and II clinical trials. He joined iQur Ltd in 2006 and his team helped develop a universal influenza vaccine based on a novel virus like particle vaccine platform. Mike is currently working as a freelance consultant.

Dr Ly-Mee Yu


Associate Professor and Deputy Academic Director, Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, Oxford

Ly-Mee Yu has over 20 years of experience as a medical statistician and specifically in clinical trials for the past 12 years.

She has worked in a wide range of clinical areas and also a member of the Oxford Tropical Research Ethics Committee, as well as a member of Data and Safety Monitoring Committee, and Trial Steering Committee of several national and international trials.


If you would like to discuss your application or any part of the application process before applying, please contact:
Course Administrator
Tel: +44 (0)1865 286958

Level and demands

Vaccinology is a cross-disciplinary subject and the most exciting developments in vaccinology have occurred when people from diverse research, business and medical backgrounds have used their skills to collectively tackle problems in vaccine design, manufacture and distribution.

Our course participants will therefore reflect the diversity of the subject and be from business, academic, clinical and veterinary backgrounds. The course will be of particular interest to research scientists, programme managers, clinical trial coordinators, nurses, physicians and veterinarians. The course will be accessible to people already working in the field or to those who wish to enter the field.

People from the following organisations and companies have attended the Oxford Vaccinology Programme:

Baxter BioScience, Baxter Innovations GmbH, Boehringer Ingelheim Animal Health GmbH, Centre for Clinical Vaccinology and Tropical Medicine (University of Oxford), Clinical Biomanufacturing Facility (University of Oxford), Commission on Human Medicines, Cumbria and Lancashire Health Protection Unit, Datamonitor, Department of Paediatrics (University of Oxford), Division of Public Health and Primary Health Care (Oxford), Drug Delivery Solutions, European Medicines Agency (EMEA), Emergent BioSolutions Inc, Federal Ministry of Animal Resources and Fisheries, Genecom, Glide Pharma, ICON Clinical Research, IDT Biologika GmbH, Imaxio, Inocul8, Institute for Animal Health (IAH), Irsicaixa, Laboritorios Leti, S.L., London School of Hygiene and Tropical Medicine, Medicago R&D, MHRA, Moredun Research Institute, Novartis, Nuffield Department of Clinical Medicine (University of Oxford), Oxford Vaccine Group, PATH Malaria Vaccine Initiative (MVI), Pfizer Ltd, Sagittarius IP, Solvay Biologicals, Solvay Pharmaceuticals Inc, Statens Serum Institut, Subiaco Associates Ltd, The Jenner Institute (University of Oxford), Tropical Medicine (University of Oxford), Vaccibody AS, Veterinary Laboratories Agency, Wellcome Trust Centre for Human Genetics, World Health Organisation, Wyeth

If you're uncertain whether this course is suitable for your requirements, please email us with any questions you may have.