Clinical Vaccine Development and Biomanufacturing

Overview

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

The course will 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 Good Manufacturing Practice (GMP) 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 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 discount worth over £300.

Programme details

The below programme may be subject to revision during the course development process.

Each day will start at 9am (unless otherwise stated) and finish no later than 6pm. The exact timings will be confirmed closer to the start date.

All timings are British Summer Time (UTC+1). A world clock, and time zone converter can be found here: https://bit.ly/3bSPu6D

Day 1 - Tuesday 7 October

  • The clinical vaccine development process
  • Introduction to vaccine types 
  • Adjuvants for vaccines in clinical trials
  • Immune mechanisms and finding correlates of protection

  • ICH Guidelines of Good Clinical Practice

  • Clinical trials in Africa

Day 2 - Wednesday 8 October

  • Morning: Guided walking tour of Oxford
  • Human and veterinary vaccinology: scientific, manufacturing and regulatory synergies
  • Introduction to biomanufacturing
  • An introduction to technology transfer
  • Specific considerations for the safety testing of novel biological and viral vaccines
  • When biology meets regulatory affairs – insights into today’s process validation of vaccines
  • Quality by Design analytics for vaccines

Day 3 - Thursday 9 October

  • Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford (Depart 08:30)
  • Introduction to Good Manufacturing Practice (GMP) upstream and downstream processes 
  • Process development case study
  • Taking lab discoveries into manufacture: a Covid-19 case study
  • Statistical considerations when designing a clinical trial
  • Accelerating outbreak response vaccine trials
  • Ethical considerations for trials in developing countries

Day 4 - Friday 10 October

  • The importance of post-vaccination surveillance. Case study: bacterial meningitis
  • Manufacturing case study: Oxford BioMedica expansion due to the Covid-19 pandemic
  • Regulatory vaccine trial applications in the UK, Europe and beyond
  • Designing and coordinating large, multi-centre, Phase III clinical trials in different age cohorts: case studies 'Rotavirus, HPV and Zoster' 

Attending in person

Further details will be emailed to you two weeks ahead of the course, including registration information. 

Please get in touch if you have not received this information within five working days of the course start date.  

In the meantime, you may wish to plan your travel: Travel information 

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

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

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/

Accessing the online course

Details about accessing the private Microsoft Teams course site will be emailed to you during the week prior to the course commencing.

Please get in touch if you have not received this information within three working days of the course start date. 

Digital Certification

In order to be eligible for a certificate of attendance, you will need to attend the whole course. Participants who meet this criterion will be emailed after the end of the course with a link, and instructions on how to access their University of Oxford digital certificate. 

The certificate will show your name, the course title and the dates of the course you attended. You will also be able to download your certificate or share it on social media if you choose to do so.

Fees

Description Costs
1. Standard course fee (online) £1425.00
2. Standard course fee (in person) £1645.00
3. Online package, including Human and Veterinary Vaccinology £2865.00
4. In-person package, including Human and Veterinary Vaccinology £3385.00

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.

Request an invoice

If you require an invoice for your company or personal records, please contact the course administration team. 

Payment is accepted online, by credit/debit card, or by bank transfer. Please do not send card or bank details via email.

Tutors

Dr Patience T Brace

Senior Vaccine Production Scientist, Pandemic Sciences Institute

Prof Daniel G. Bracewell

Professor of Bioprocess Analysis, UCL Department of Biochemical Engineering

Prof Mark Doherty

Senior Manager, GlaxoSmithKline Biologicals

Prof Sandy Douglas

Group Head / PI, University of Oxford

Prof Mainga Hamaluba

Associate Professor, Nuffield Department of Medicine, University of Oxford

Dr Shawkat Hussain

Associate Director, Bioprocess and Analytical Development, The Jenner Institute

Dr Dominic Kelly

BRC Consultant in Paediatrics and Vaccinology, University of Oxford

Dr César López-Camacho

Senior Researcher, The Jenner Institute

Dr Laura Merson

Associate Director, Infectious Diseases Data Observatory (IDDO)

Dr James Miskin

Chief Technical Officer, Oxford Biomedica

Prof Michael Parker

Professor of Bioethics, Director of the Ethox Centre, University of Oxford

Dr Martin Pech

IDT Biologika

Dr Peter Spencer

Senior Quality Lead, Coalition for Epidemic Preparedness Innovations (CEPI)

Dr Richard Tarrant

Quality Assurance Manager, Clinical Bio-Manufacturing Facility, University of Oxford

Dr Mike Whelan

Vaccine Developer

Prof Ly-Mee Yu

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

Application

If you would like to discuss your application or any part of the application process before applying, please click 'Ask a question' 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 will come 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 in previous years:

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. 

Enrolled students are entitled to discounted accommodation rates for the purpose of study, at Rewley House, and can contact the administration team for the promotional code to use for making online accommodation bookings via the website.

IT requirements

For those attending the course remotely, the course will be streamed using Microsoft Teams. You will be required to follow and implement the instructions we send you to fully access Microsoft Teams on the University of Oxford's secure IT network.

To participate you must be familiar with using a computer for purposes such as sending email and searching the Internet. You will also need regular access to the Internet and a computer meeting our recommended minimum computer specification.

It is advised to use headphones with working speakers and microphone.