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).

Programme details

The below programme is from last year's course, and may be subject to revision during the course development process.

Day 1 (Teaching 09:00 - 17:15)

  • Prelude to human and veterinary vaccinology: scientific, manufacturing and regulatory synergies
  • The clinical vaccine development process
  • Introduction to vaccine types 
  • Adjuvants for vaccines in clinical trials
  • Immunomonitoring and immune correlates

  • ICH Guidelines of Good Clinical Practice

Day 2 (Teaching 09:00 - 17:00)

  • Introduction to biomanufacturing
  • An introduction to technology transfer
  • Specific considerations for the safety testing of novel biological and viral vaccines
  • Quality by Design analytics for vaccines
  • Vaccines - Process development challenges for today's process validation
  • Clinical trials in Africa
  • Evening: Guided walking tour of Oxford

Day 3 (Teaching 08:45 - 17:30)

  • Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford (Depart 08:30)
  • Introduction to GMP upstream and downstream processes 
  • Process Development case study
  • Taking lab discoveries into manufacture - a COVID19 case study
  • Manufacturing case study: Oxford BioMedica expansion due to Covid pandemic

  • Regulatory vaccine trial applications in the UK, Europe and beyond

Day 4 (Teaching 09:00 - 15:45)

  • Accelerating outbreak response vaccine trials
  • The importance of post-vaccination surveillance. Case study: Bacterial Meningitis
  • Statistical considerations when designing a clinical trial
  • Ethical considerations for trials in developing countries
  • 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. 

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
10% discount: register for both in-person vaccinology courses £3075.00
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

Dr Sandy Douglas

Course Tutor

Group Head / PI, University of Oxford

I am an academic clinician and hold a Wellcome Trust Postdoctoral Fellowship for Clinicians (i.e. Career Development fellowship). My main interests are the development of antibody-inducing vaccines against the sporozoite stage of malaria and the development of a novel thermostable rabies vaccine.

In earlier work, I identified the potential of PfRH5 as an antigen capable of inducing highly potent strain-transcending neutralising antibodies against the disease causing blood-stage of Plasmodium falciparum and demonstrated that PfRH5-based vaccines could achieve in vivo protection against a virulent P. falciparum challenge. These vaccines are now in clinical trials.

Dr Mike Whelan

Course Tutor

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 Rebecca Ashfield

Course Tutor

CSO,  Ducentis Biotherapeutics Ltd

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

Dr Ashfield worked for 12 years 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. She is now the CSO of Ducentis Biotherapeutics Ltd.

Caesar Atuire

Course Tutor

Dr Eleanor Berrie

Course Tutor

Qualified Person, Clinical Biomanufacturing Facility (CBF), University of Oxford

Dr Eleanor Berrie is Qualified Person for The Clinical Biomanufacturing Facility (CBF), University of Oxford, in this role she is registered with the MHRA as QP for IMPs. Eleanor has a background in advanced therapy Investigational Medicinal Products in both biotech and academic settings. She is responsible for the management of the quality and regulatory compliance of novel academic projects produced within the CBF’s GMP facility. In addition to this Eleanor supports clinical colleagues in regulatory submissions to ensure EU GMP compliance; audits international pharmaceutical suppliers and acts as a specialist consultant in this area as required.

The Clinical Biomanufacturing Facility has 15 years’ experience producing biological Investigational Medicinal Products (IMPs) according to the principles of GMP for early phase clinical trials. The CBF provides the link between academic research and clinical drug development, allowing our collaborators to progress into clinical trials. The CBF holds a Manufacturer’s Authorisation for Investigational Medicinal Products (MA (IMPs)) from the Medicines and Healthcare products Regulatory Agency (MHRA) and has 3 nominated Qualified Persons (QP).

Dr Mark Doherty

Course Tutor

Senior Manager, GlaxoSmithKline Biologicals

Mark Doherty obtained a bachelor’s degree in Biochemistry and Microbiology (double major) in 1983 and in Microbiology with 1st class honours in 1986, both from Massey University in New Zealand, before completing a PhD in Immunobiology at the Auckland University School of Medicine in 1989.

Subsequently he worked at the DNAX research Institutes and the National Institutes of Health in the United States, and at the Statens Serum Institute in Copenhagen. During this period, he also held adjunct professorships at the Gade Institute for International Health, at the University of Bergen in Norway and St. John’s School of Medicine in Bangalore, India. He has also been a Gates Senior Visiting Research Fellow at Aeras/NIH, and a WHO Distinguished Visiting Professor at the University of Sao Paulo in Sao Paulo, Brazil.

In 2011, Prof. Doherty joined GSK, where he works today as a senior manager in the Above Brands/Vaccine Science team.Prof. Doherty’s expertise is in the development of the early immune response - particularly the interactions of T cells and antigen presenting cells that can influence the development of T cell helper subsets. In this area, his particular specialties have been immune cell crosstalk and cytokine biology.  This work has focused strongly on practical applications of basic research, such as biosignatures of infection and disease, or adjuvant and vaccine design.

At GSK he provides support and expertise on issues such as adjuvant safety and development, maternal and risk-group vaccination and basic immunology that are relevant to multiple vaccines. He has particular interest in vaccination for older adults and vaccines as a tool for antimicrobial stewardship.

At GSK he continues to work with academic colleagues on ongoing clinical field studies, to publish in peer-reviewed journals, to work as an editor on various immunology journals, to work participate in WHO working groups, and to lecture and teach externally in immunology and vaccinology.

Dr Katie Ewer

Course Tutor

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.

Dr Mainga Hamaluba

Guest Speaker

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

Simone Kardinahl

Guest Speaker

Dr Dominic Kelly

Course Tutor

BRC Consultant in Paediatrics and Vaccinology, University of Oxford

Dr. Kelly is a BRC funded consultant in paediatrics and vaccinology. He divides his time between working in general paediatrics and paediatric infectious disease at the Children’s Hospital in Oxford and vaccine related research within the Oxford Vaccine Group.

His research interests are centred around vaccines and vaccine preventable disease in childhood and include the immunology of B-cell responses to vaccines in childhood, B-cell receptor genetics as a tool for understanding immune responses, pneumococcal conjugate vaccines and the epidemiology of invasive bacterial disease and pneumonia in Nepal.

Prof Teresa Lambe

Course Tutor

Associate Professor and Principal Investigator at The University of Oxford

Teresa Lambe is an Associate Professor and Principal Investigator in the Medical Sciences Division at the University of Oxford. Prof Lambe’s specific areas of expertise include zoonotic disease description, vaccine development and clinical trial assessment of interventions. She continues to work on vaccines against globally important diseases including Ebola, Influenza, Nipah, MERS, and Crimean-Congo haemorrhagic fever.

Prof Lambe is one of the Principal Investigators overseeing the Oxford/AstraZeneca vaccine programme. In January 2020, Teresa co-designed the vaccine, led the preclinical studies and then oversaw the delivery of the immune results needed to support regulatory approval of the vaccine in late 2020. The vaccine has been delivered to nearly half a billion people worldwide and has played a pivotal role in the fight against COVID-19. Prof. Lambe was awarded an honorary OBE in the Queen's Birthday Honours in 2021.

Laura Merson

Course Tutor

Associate Director, Infectious Diseases Data Observatory (IDDO)

Laura Merson joined ERGO and IDDO in 2015 to support new platform initiatives for emerging infections and neglected tropical diseases, including coordination of the Ebola Data Sharing Platform. This joint position integrates many of Laura’s research interests including exploring issues in sharing biomedical research data and in changing the paradigm of clinical research in outbreaks to enable rapid research response to emerging infections. As an executive member of the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), Laura has contributed to the development of standardized, open-access research protocols designed for outbreak response in collaboration with the World Health Organization. Before moving to Oxford, Laura spent more than six years building capacity in research design, implementation and ethics across Asia and Africa as Head of Clinical Trials for the Oxford University Clinical Research Unit Viet Nam.

Dr James Miskin

Course Tutor

Chief Technical Officer, Oxford Biomedica

Dr Miskin joined Oxford Biomedica in 2000. He has more than 17 years experience in the GxP environment. In his current role, he has overall responsibility for Oxford Biomedica’s Quality systems, analytical testing, lentiviral based bioprocessing development and client programmes.  He is also a named inventor on several patents in the field. He holds a Bachelor of Science degree and a PhD in Molecular Biology from the University of Leeds and subsequently conducted post-doctoral research at The Pirbright Institute for a number of years. He is an active member of the UK BioIndustry Association Manufacturing Advisory Committee and is the Advanced Therapies work stream lead for The Medicines Manufacturing Industry Partnership (MMIP).

Martin Pech

Guest Speaker

Dr Lee Smith

Course Tutor

Dr. Lee Smith’s experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.

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

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.

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.