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 favorable environment, making it an excellent incubator for the development of concepts.
SESSION 1- THE MULTIFACETED NATURE OF VACCINOLOGY |
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The purpose of this session is to describe the roles, responsibilities and perspectives of the multiple players involved in the field of vaccinology and describe the complexities of their tasks. |
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How to develop a new program of immunization |
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Access to vaccination in Gavi countries and at global level |
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A global perspective on the regulation of vaccines | ||
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The challenge of malaria vaccines and of their potential introduction |
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SPECIAL LECTURES FROM INDUSTRY |
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Role of LMIC vaccine industry for meeting global needs | ||
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Development and production of vaccines for global use: the role of the vaccine industry | ||
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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 (interactive session) | ||
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Immunological memory | ||
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Advances in vaccine and immunization technologies |
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Debate: Mandatory versus voluntary vaccination | ||
An interactive debate on vaccine policy allowing various implementation policy perspectives to be shared and discussed and perhaps modified, among students. It will demonstrate, by using pre/post debate discussion voting, how opinions can be influenced by pro/con rationales and data. After participating in the debate, participants will be able to:
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SESSION 3 - DECISION-MAKING IN VACCINE RESEARCH AND PRECLINICAL DEVELOPMENT |
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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 considerations involved in vaccine development. Efforts to identify contemporary issues and approaches being discussed in this area are highlighted, as are the various positions being debated. |
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How do vaccines cause adverse events? |
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Vaccine adjuvants |
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From preclinical research to vaccine development: examples of go-no-go decisions | ||
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The complexity of quality control in vaccine manufacturing | ||
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Regulatory considerations: a round-table debate | ||
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Debate: From ideas to implementation: - the realities of funding for vaccine research and development |
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SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (I) |
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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. |
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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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Small group exercise 1: How to design, recruit volunteers for, and analyse the results of selected phase 2 trials | ||
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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. |
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Lessons learned from previous adverse effects of vaccination and causality assessment |
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Vaccination and immune-mediated diseases | ||
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Population-based post-licensure surveillance | ||
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Vaccination and narcolepsy | ||
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Immunization safety in low and middle income country vaccination programs | ||
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Addressing vaccine hesitancy | ||
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Dealing with Human Challenge Trials: panel discussion and questions | ||
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SESSION 6 - ASSESSING VACCINES IN CLINICAL TRIALS (II) |
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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. |
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Introduction to statistical aspects of clinical trials: Statistical assessment and reporting of Phase 3 trials | ||
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Small group exercise 2: Designing and analysing the results of selected phase 3 trials | ||
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SESSION 7 - 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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Small group exercise 3: Ethical considerations in malaria vaccine trials | ||
Using a student-led role play approach to address issues arising from the trial and study objectives, setting and participants’ health status as well as issues related to world view and religion, after the exercise, participants will be able to:
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SESSION 8 - INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMS |
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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. It will include detailed information regarding relevant vaccines for which implementation policy decision-making was recently made, is still in process, or may shortly be made. |
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Disease burden and the public health value of vaccines |
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Health economics (incl. modelling) as a tool in analysing vaccine policy | ||
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Challenges and solutions in making evidence-based national vaccination policies and recommendations | ||
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Dengue vaccines | ||
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Response to polysaccharides and conjugates vaccines: basic aspects |
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Pneumococcal conjugate vaccines: Efficacy and limitations of available vaccines and existing and potential vaccination strategies | ||
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Non-specific effects of vaccines | ||
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Debate: Does a vaccine have to protect against a VPD that kills to matter to politicians and parents? | ||
Using pro/con debate format:
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HPV vaccines | ||
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Vaccine responses and efficacy in the elderly (including the example of the Zoster vaccine) | ||
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Meningococcal vaccines | ||
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Pathogens evolution and population immunity: methods and applications for vaccine development and policy | ||
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Population biology of bacterial pathogens and its importance for vaccination strategies | ||
An in-depth analysis of specific pathogens, including Bordetella pertussis and Neisseria meningitidis, will be used to illustrate the points outlined above. |
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Success and challenges with rotavirus and norovirus vaccines | ||
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Small group exercise 4: Decision-making for the evaluation and impact assessment of new vaccines introduced in selected countries: safety and effectiveness. | ||
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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Impact of vaccination on disease epidemiology | ||
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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. |
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Vaccination and pregnancy: scientific basis, main issues and applications |
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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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Influenza biology, new vaccines and vaccination strategies for different age groups | ||
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Vaccination in immuno-compromised individuals, including HIV positive patients | ||
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History of vaccines and vaccination | ||
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Debate: Mandatory versus voluntary vaccination | ||
An interactive debate on vaccine policy allowing various implementation policy perspectives to be shared and discussed and perhaps modified, among students. It will demonstrate, by using pre/post debate discussion voting, how opinions can be influenced by pro/con rationales and data. After participating in the debate, participants will be able to:
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SESSION 10 – VACCINES UNDER DEVELOPMENT |
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The status of the vaccine development pipeline for high impact/visible vaccines will be described and discussed. | ||
Vaccines against epidemic and orphan diseases: how technologies can change vaccine development | ||
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Global challenges for pertussis vaccines | ||
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HIV vaccines | ||
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Challenges and prospects for new tuberculosis vaccines | ||
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Cancer vaccines | ||
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SESSION 11 – OUTBREAKS’ CONTROL: ELIMINATION AND ERADICATION STRATEGIES |
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The challenges and the status on eradication/elimination programs will be described together with the challenges and ways to increase vaccination coverage. New implementation tools will also be described. | ||
Immunization coverage gaps: overcoming the chronic challenges | ||
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Polio | ||
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Measles and rubella | ||
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SESSION 12 – 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 |
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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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SESSION 13 – RECAP |
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The purpose of this session is to answer any remaining questions from participants of general interest building on the body of information presented during the course and to help solidify knowledge through briefly reviewing the entirety of critical information received during the course flagging the most important points from each lecture/training activities |
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Panel: answers to important questions from participants either received beforehand or live during the panel session Highlights from ADVAC 2023 |
PARALLEL WORKING GROUP SESSIONS |
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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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Parallel Working Group Session 1 | ||
1) AEFI: causality assessment | ||
Through an interactive case-study session, participants will after the workshop be able to:
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2) Monitoring and evaluation of vaccine programs | ||
After the working group session will be able to:
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Parallel Working Group Session 2 | ||
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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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 IN RELATION TO SESSION 2 | ||
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PLOTKIN LECTURE IN RELATION TO SESSIONS 8 TO 11 | ||
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