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.

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

  • Course Introduction
  • Prelude to human and veterinary vaccinology: scientific, manufacturing and regulatory synergies
  • Introduction to vaccine platforms
  • The clinical vaccine development process
  • Immune mechanisms and finding correlates of protection

  • Key challenges and considerations in Phase 3/4 trial management

  • Vaccine research funding, translation and commercialisation - caveats and success stories

Day 2 - Wednesday 8 October

  • Introduction to biomanufacturing
  • Taking lab discoveries into manufacture - a COVID19 case study
  • Regulatory vaccine trial applications in the UK, Europe and beyond
  • Fundamentals of technology transfer
  • Safety testing of novel biological and viral vaccines
  • Vaccine Production Considerations in Good Manufacturing Practice (GMP) (Part I)

Day 3 - Thursday 9 October

  • Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford (Depart 08:30)
  • Vaccine Production Considerations in GMP (Part II) 
  • Introduction to GMP upstream and downstream processes
  • Process Development case study
  • Introduction to RNA vaccine technologies
  • Regulatory vaccine trial applications in the UK, Europe and beyond
  • Industry case study: Vaccine development at Moderna against Respiratory Syncytial Virus (RSV)
  • Meet-the-speakers Q&A at The Oxford Wine Café, Little Clarendon Street

Day 4 - Friday 10 October

  • Case study: Phase 3 vaccine trials in Africa - the R21 malaria vaccine story
  • Ethical considerations for trials in developing countries
  • Statistical considerations when designing a clinical trial
  • The importance of post-vaccination surveillance. Case study: Bacterial Meningitis

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 the tour of the Clinical Biomanufacturing Facility (CBF), University of Oxford, or the Meet-the-speakers Q&A.

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
3. Online package, including Human and Veterinary Vaccinology £2865.00

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

The full list of tutors and their biographies can be found here.

Dr César López-Camacho

Senior Researcher, The Jenner Institute

Dr Elizabeth Clutterbuck

Oxford Vaccine Group, University of Oxford

Dr Mike Whelan

Vaccine Developer

Prof Daniel G. Bracewell

Professor of Bioprocess Analysis, UCL Department of Biochemical Engineering

Dr Richard Tarrant

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

Dr Shawkat Hussain

Associate Director, Bioprocess and Analytical Development, The Jenner Institute

Dr Patience T Brace

Senior Vaccine Production Scientist, Pandemic Sciences Institute

Dr Matthew Snape

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

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

Dr Mark Sheehan

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

Prof Sandy Douglas

Group Head / PI, University of Oxford

Susanne Hodgson

Clinician Scientist, Nuffield Department of Medicine, University of Oxford

Alison Lawrie

Senior Vaccine Development Co-ordinator and Head of Regulatory Affairs, The Jenner Institute

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.

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.