General objectives
The Course aims to facilitate critical decision-making in vaccinology by providing participants with a comprehensive overview of the various aspects of vaccinology (immunology, vaccine development, clinical trials, regulatory processes, vaccine-specific issues including new vaccines, vaccination strategies and policies, programme implementation, humanitarian emergencies, social, economic, political and ethical issues, financing, and communications…).
By the end of the course, participants should be able to:
- Use rational criteria for decisions related to evidence-based introduction of new vaccines into immunization programs;
- Identify requirements for vaccination strategies to be used in special conditions: eradication strategies, vaccination of neonates, elderly, immunocompromised and HIV infected persons;
- Deal with issues regarding vaccine trials (including site selection, recruitment aspects, monitoring, evaluation and ethical considerations);
- Identify recent developments towards new or improved vaccines and new vaccination strategies;
- Appraise all aspects of vaccines and vaccination safety, including vaccine delivery and reporting of adverse events following immunization;
- Initiate appropriate actions in crises associated with real or alleged vaccine adverse events;
- Recognize the role of communication in vaccine program and policy;
- Determine any necessary important change to their practice of vaccinology.
With its 360° vision of vaccinology, the ADVAC program describes the approaches required for the translation of scientific and epidemiological evidence into effective policy development related to vaccines and immunization.
ADVAC aims to expand the scientific foundation of the participants and their knowledge in vaccinology areas outside of their current expertise, showing the multifaceted aspects of vaccinology, allowing them to explore novel technologies and think more globally and holistically, and providing them with a unique skill set to develop their leadership in vaccinology.
ADVAC represents a unique networking opportunity where participants can form valuable and sustainable professional relationships, and serves as a platform where problems to professional challenges can be shared and solutions identified.
By learning from, and alongside, other ADVAC students from other fields and organizations,
ADVAC is uniquely oriented to help advance the field of vaccinology by sharing practical insights focused on implementation at a basic science level and on a public health scale. It brings together some of the leading experts in vaccinology and motivated students in a favourable environment, making it an excellent incubator for the development of concepts.
Specific objectives for each training activity (lectures, debates, interactive sessions, small group exercises and parallel workshops/sessions)
SESSION 1 - THE VACCINES JOURNEY: FROM VACCINES TO VACCINATION (INCLUDING IMPACT OF VACCINES). |
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The purpose of this session is to describe the various steps needed from research to immunization of individuals and the roles, responsibilities and perspectives of the multiple players involved in the field of vaccinology and describe the complexities of their tasks. | ||
From research to individual protection: the A-to-Z vaccine’s journey | ||
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A quick overview of the vaccinology concepts | ||
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Measuring vaccination’s impact in populations | ||
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Where are we with vaccine-preventable diseases & immunization coverage worldwide: the state of the immunization | ||
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The determinants of a good immunization coverage and how GAVI is supporting countries to reach more children | ||
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Using vaccines to solve a public health problem: the example of Polio eradication | ||
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SESSION 2 - HOW VACCINES WORK |
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The purpose of this session is to describe the relevancy of foundational immunological knowledge to practical applications. Contemporary and historical examples of successes and failures are used to re-enforce the concepts. | ||
How are vaccine responses elicited? |
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Use and limitations of correlates of immunity in vaccinology |
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Vaccines and mucosal immunity |
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Vaccines and immunological memory (Q & A session) | ||
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Immunological memory | ||
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Tailoring vaccine immunogenicity with adjuvants | ||
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Non-specific effects of vaccines | ||
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SESSION 3 - VACCINE TECHNOLOGY, MANUFACTURING AND APPROVAL. |
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The purpose of this session is to build up the basic research vaccine concepts previously presented and define the pre-clinical, manufacturing and approval considerations involved for vaccines. Efforts to identify contemporary issues and approaches being discussed in this area are highlighted, as are the various positions being debated. | ||
Landscape in vaccine and immunization technologies: |
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Concepts of Chemistry, Manufacturing, and Controls (CMC) for vaccines | ||
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The complexity of quality control in vaccine manufacturing | ||
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The Role of regulatory agencies | ||
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How to manage regulatory requirements during vaccine development and vaccine production in both HICs and LMICs (small group exercise 1) | ||
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From ideas to implementation - the realities of funding for vaccine research and development in the private sector (Interactive session 1) | ||
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Delivering a pandemic vaccine in 100 Days: what does it take? | ||
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Everything you always wanted to know on what makes funders support research-development: ask all your questions to governmental agency, venture capitalists, industry and philanthropic organizations. (Interactive session 2) | ||
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SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (Part 1) |
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Building on the knowledge obtained from the previous session, this session will expand into a description of vaccine clinical trials including design options for the various categories of trials. The role of the students will also expand as they participate /lead small group/individual role play involving design of clinical trials and financing of vaccine development ideas. Real world complexity and context are explained | ||
Clinical trials: an overview of issues to be considered |
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Introduction to statistical aspects of clinical trials: Defining sample size | ||
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How to design, recruit volunteers for, and analyse the results of selected phase 2 trials (Small group exercise 2) | ||
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Assessing herd protection and vaccine effectiveness (and use for licensure) | ||
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Clinical trials: role of Data Safety Monitoring Boards (DSMBs) |
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Introduction to Human Challenge Trials | ||
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SESSION 5 - VACCINE SAFETY - ASSESSMENT OF ADVERSE EFFECTS |
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The purpose of this session is to describe in depth and synthesize all issues related to vaccine safety and ways to assess, prevent and mitigate adverse events | ||
How do vaccines cause adverse events ? |
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Vaccination and immune-mediated diseases | ||
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WHO Guidance on how to manage safety issues | ||
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Population-based post-licensure surveillance | ||
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Immunization safety in low- and middle-income country vaccination programs | ||
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SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (Part 2) |
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The purpose of this session is to review Phase 3 clinical trial design/complexity. Following the session, students will be able to design a Phase 3 clinical trial | ||
Introduction to statistical aspects of clinical trials: Statistical assessment and reporting of Phase 3 trials | ||
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Designing and analyzing the results of selected phase 3 trials (small group exercise 3) | ||
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SESSION 6 - ETHICAL ISSUES |
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The purpose of this session is to describe ethical considerations and challenges and identify accepted ethical guidelines relevant to vaccines | ||
Principles, guidelines and framework for ethical considerations in clinical trials of vaccines | ||
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Applied ethics in immunization programs and practice |
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Ethical considerations in COVID-19 vaccine trials (Small group exercise 4) | ||
Using a student-led role play approach to address issues arising from the trial and study objectives, context and participants’ health status, after the exercise, participants will be able to:
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SESSION 7 - DECISION MAKING FOR VACCINES (Part 1) |
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Continuing down the vaccine development pathway, this session will focus on an in-depth discussion of the science/factors/approaches involved in bringing a vaccine into the public-health setting. | ||
The decision-making processes for vaccines use: global, regional and local perspectives | ||
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The example of the WHO SAGE decision making processes | ||
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The role of health economics (including modelling) as a tool in analysing vaccine policy options | ||
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Decision-making for the evaluation and impact assessment of new vaccines introduced in selected countries: safety and effectiveness. (small group exercise 5) | ||
Through an interactive small group exercise focusing on different vaccines and which aim to develop the rationale for the introduction of the selected vaccine to the selected target groups and culminating in a 2-3 minutes oral presentation to a simulated Minister of Health, participants will be able to:
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SESSION 8 – UPDATES ON VACCINES (part 1 and 2) |
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The objective of this session is to provide an exhaustive view of some key vaccines included in national programs and to give the latest information regarding those vaccines (new vaccines, changes of schedule…). | ||
Response to polysaccharides and conjugates vaccines |
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Pneumococcal conjugate vaccines: Efficacy and limitations of available vaccines and existing and potential vaccination strategies | ||
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HPV vaccines | ||
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Typhoid vaccines | ||
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Meningococcal vaccines | ||
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Vaccines against arboviruses (Dengue, Zika, Chikungunya) | ||
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Rotavirus and norovirus vaccines | ||
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Influenza vaccines | ||
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COVID vaccines | ||
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SESSION 7 – DECISION MAKING FOR VACCINES (Part 2) |
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Decision-making for the evaluation and impact assessment of new vaccines introduced in selected countries: safety and effectiveness. Part 2: Presentations, discussion and conclusions (small group exercise 5) |
SESSION 9 - SELECTING APPROPRIATE VACCINATION STRATEGIES |
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The purpose of this session is to describe additional considerations to proposals for a vaccine implementation program, specifically rationales for population choice, schedules, and follow-up | ||
Vaccination and pregnancy |
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Vaccination in early life | ||
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Vaccination schedules: Past, present and future – is there some rationale? | ||
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Vaccine responses and efficacy in the elderly | ||
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Vaccination in immuno-compromised individuals, including HIV positive patients | ||
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SESSION 8 – UPDATES ON VACCINES (part 3) |
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Malaria vaccines | ||
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Cholera vaccines | ||
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Tuberculosis vaccines | ||
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Session 10 – REACHING SPECIFIC GROUPS. |
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During this session, participants will explore the challenges and solutions for reaching out all the populations that can benefit from immunization (hard to reach, life-long immunization etc…). | ||
How to better reach the zero-dose or under-vaccinated children in LMICs | ||
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Life-course vaccines: how to better reach individuals from childhood to elderly ? | ||
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The determinants of vaccine acceptance | ||
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How to address vaccine hesitancy at individual and community levels? Interactive debate | ||
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SESSION 11 - FACING THE MEDIA: WHAT THE VACCINOLOGIST SHOULD KNOW IN THE CONTEXT OF VACCINE HESITANCY AND ANTI-IMMUNIZATION LOBBY |
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Introduction to media dynamics: how to best deliver vaccinology-related messages to different interest groups | ||
After this highly interactive session, students will gain confidence to discuss the complexities of vaccine with multiple audiences. The learning will apply to all kinds of communication with the public including 1-2-1, with patients, in panel discussions and video conferencing. Specific objectives include the ability for participants to:
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PARALLEL WORKING GROUP SESSIONS | ||
The six proposed working group activities grouped in two separate parallel sessions will be highly interactive and foster an exchange of views. During each of these parallel sessions, students will be able to choose and attend one of the working group activities offered. The other activities will be recorded so that the students will be able to benefit from the recording of any other working group discussions of interest. |
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1. National decision-making for immunization programs | ||
Through case-studies and an interactive session building on the experience, expertise and perceptions of the entire group, participants will after the workshop be able to:
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2. Clinical vaccinology: patients' problem solving | ||
Through an interactive session, participants after the working group session will be able to:
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3. New approaches towards vaccination e-registries | ||
Through an interactive session, participants will after the session, be able to:
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4. Cold Chain management | ||
Through an interactive session, participants will after the session be able to:
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5. AEFI: WHO causality assessment | ||
Through an interactive case-study session, participants will after the workshop be able to:
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6. Monitoring and evaluation of vaccine programs | ||
After the working group session will be able to:
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SPECIAL LECTURES
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Each year special lectures are delivered on a current topic of interest by world renowned experts allowing to present state of the art developments on immunological, vaccine development and strategy issues. |
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LAMBERT LECTURE | ||
The 8th LAMBERT LECTURE: RSV vaccines from research to implementation |
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PLOTKIN LECTURE |
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The 16th PLOTKIN LECTURE: Climate Change and Immunization |