Clinical Vaccine Development and Biomanufacturing

Overview

This course can also be taken online - see 'Online course information' below.

Designed and developed in close collaboration with leading clinicians, veterinarians and industrial partners who conduct clinical trials.

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 Oxford Vaccinology Programme provides state-of-the-art teaching in both human and veterinary vaccinology, drawing on the experience of Oxford University, the world-renowned the Jenner Institute based in Oxford and our partners in industry. It is taught by experts from the University of Oxford, academia and industry.

The course is designed as a stand-alone module or can be taken as an add-on to the Human and Veterinary Vaccinology module. Book together to receive a 10% discount (a saving of over £300.00).

Note: the information below relates to the previous course but the October 2022 course will be broadly similar in format. We will update this webpage as soon as we have details.

Programme details

The timetable and tutors shown are provisional and may be subject to change.

Day 1

  • Introduction to vaccine types
  • Taking lab discoveries into manufacture
  • GMP Manufacturing of IMPs -  a QP’s Perspective
  • Flu vaccine manufacture and clinical development
  • CASE STUDY (Influenza Vaccine Planning)

Day 2

  • Introduction to GMP upstream and downstream processes
  • Process Development case study
  • Manufacturing and quality risk management during the vaccine development and manufacturing process
  • Clinical development overview
  • Immunomonitoring and Immune correlates

Evening: Guided walking tour of Oxford

Day 3 

  • Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford
  • ICH Guidelines of Good Clinical Practice
  • Clinical trials in developing countries
  • The importance of post - vaccination surveillance. Case study: Bacterial Meningitis
  • Designing and coordinating large, multi - centre, Phase III clinical trials in different age cohorts: case studies 'Rotavirus, HPV and Zoster'

Day 4

  • Statistical considerations when designing a clinical trial
  • Adjuvants for vaccines in clinical trials
  • Ethical considerations for trials in developing countries
  • Closure of meeting / feedback

The above content may be subject to revision during the course development process.

Online course information:

The online version of the course will be broadcast live on Microsoft Teams. You will have access to all the live sessions as they are taught in the classroom.

You will be able to ask questions via the ‘Chat’ feature on Teams and we will also provide two-way video/audio so you can see the tutors teaching and ask questions directly (you will need to use a connected device with a microphone for this such as a laptop or smartphone).

If you are taking the course online, you will not be able to participate in:

1.   The walking tour and social evening

2.   Tour of the Clinical Biomanufacturing Facility (CBF), University of Oxford

You will need to attend all the live sessions to qualify for a course certificate. Recordings of the live sessions will not be available.

In order to successfully attend this course online, your connected device should meet the following IT requirements - https://onlinesupport.conted.ox.ac.uk/system-requirements/

 

Certification

Participants who attend the full course will receive a University of Oxford certificate of attendance. This will be presented to you prior to the end of the course wherever possible.

The certificate will show your name, the course title and the dates of the course you attended.

Fees

Description Costs
10% discount: register for both in-person vaccinology courses £2790.00
Save £125: register for both online courses £2495.00
Standard course fee (in-person) £1375.00
Standard course fee (online) £1175.00

Payment

Fees include course materials, tuition, refreshments and lunches. The price does not include accommodation.

All courses are VAT exempt.

Register immediately online 

Click the “book now” button on this webpage. Payment by credit or debit card is required.

Student Discounts

On this course we offer a 10% discount to students in full-time higher education. To apply at the discounted rate, please contact us for details.

Tutors

Prof Adrian Hill

Course Director

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

Prof Sarah Gilbert

Speaker

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, Sir Andrew Pollard

Speaker

Director, Oxford Vaccine Group, University of Oxford

Principal areas of research: Paediatric vaccines, meningitis vaccines, the development of the immune response.

Professor Sir Andrew Pollard (BSc, MBBS, PhD London, FRCPCH) is the academic lead for the Postgraduate Diploma. He is Professor of Paediatric Infection and Immunity at Oxford University and Honorary Consultant Paediatrician at the Children's Hospital, Oxford. He leads a research group (The Oxford Vaccine Group) working on clinical trials of new and improved vaccines for the prevention of infection in children.

Application

If you would like to discuss your application or any part of the application process before applying, please click Contact Us at the top of this page.

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.

Accommodation

Although not included in the course fee, accommodation may be available at our on-site Rewley House Residential Centre. All bedrooms are en suite and decorated to a high standard, 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.

To check prices, availability and to book rooms please visit the Rewley House Residential Centre website.