Clinical Vaccine Development and Biomanufacturing

Overview

This course can 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).

Programme details

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

Day 1 - Tuesday 8 October (Teaching 09:00 - 17:40)

  • 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 9 October (Teaching 10:20 - 18:30)

  • 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 10 October (Teaching 10:40 - 19:00)

  • Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford (Depart 08:30)
  • Introduction to Good Manufacturing Practica (GMP) upstream and downstream processes 
  • Process Development case study
  • Taking lab discoveries into manufacture - a COVID19 case study
  • Statistical considerations when designing a clinical trial
  • Accelerating outbreak response vaccine trials
  • Ethical considerations for trials in developing countries

Day 4 - Friday 11 October (Teaching 09:00 - 14:20)

  • The importance of post-vaccination surveillance. Case study: Bacterial Meningitis
  • Manufacturing case study: Oxford BioMedica expansion due to Covid 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 the in-person course

Further details will be emailed to you two weeks ahead of your course, which will include 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

You will need to attend all the live sessions to qualify for a course certificate. Recordings of the live sessions may 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/

Accessing the online course

Details about accessing the private MS 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

To complete the course, you will be required to attend and participate in all of the sessions on the course in order to be considered for a certificate. Participants who complete the course will receive a link to download a University of Oxford digital certificate. Information on how to access this digital certificate will be emailed to you after the end of the course.

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
Save £325: register for both online courses £2745.00
Standard course fee (in-person) £1495.00
Standard course fee (online) £1295.00

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.

Tutors

Prof Sandy Douglas

Course Tutor

Group Head / PI, University of Oxford

Dr César López-Camacho

Course Tutor

Senior Researcher, Jenner Institute

Dr Mike Whelan

Course Tutor

Vaccine Developer

Dr Laura Merson

Course Tutor

Associate Director, Infectious Diseases Data Observatory (IDDO)

Dr Richard Tarrant

Course Tutor

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

Dr Martin Pech

Guest Speaker

Prof Mainga Hamaluba

Guest Speaker

Prof Daniel G. Bracewell

Course Tutor

Professor of Bioprocess Analysis, UCL Department of Biochemical Engineering

Dr Ly-Mee Yu

Course Tutor

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

Dr Dominic Kelly

Course Tutor

BRC Consultant in Paediatrics and Vaccinology, University of Oxford

Dr James Miskin

Course Tutor

Chief Technical Officer, Oxford Biomedica

Prof Mark Doherty

Course Tutor

Senior Manager, GlaxoSmithKline Biologicals

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. 

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.