objective 2The course aims to facilitate critical decision-making in vaccinology by providing participants with a comprehensive overview of the field, from immunology to vaccine development and clinical trials and the social, economic, political and ethical issues of vaccination.

FIRST DAY

SESSION 1a - THE MULTIFACETED NATURE OF VACCINOLOGY

 
Impact of vaccination on disease epidemiology:
  • Introduce the basic concepts of infectious disease epidemiology.
  • Describe how to measure key epidemiological parameters (e.g. the basic reproductive number, R0) for serological profiles.
  • Describe the impact of vaccination on epidemiological pattern.
  • Define vaccination coverage levels by age to halt transmission.
  • Define what an imperfect vaccine is.
  • Give example of the impact of current mass vaccination programmes in different regions of the world.
  • Discuss challenges in measurement and observation in the epidemiological study of mass vaccination.
Access to vaccination in Gavi countries and at global level:
  • Understand some of the factors and forces which led to the formation of Gavi Alliance.
  • Form an opinion about the Gavi “model”.
  • Be able to compare some of the differences between each 5 year strategic period (Gavi 1.0, 2.0, 3.0 and 4.0).
  • Review some of the targets set and reported against, in Gavi’s fund raising efforts.
  • Understand the role of country co-financing in the Gavi model.
  • Review some of the options going forward for the Gavi Alliance.
How to develop a new program of immunization:
  • Students will have insights into reasons why new vaccines are introduced into national programmes and consider reasons why they may not be introduced. Examples will be given of elements that go into decisions about new vaccines and the data that need to be brought together to support such decisions.
  • Students will be encouraged to think about the sources of evidence that are used by decision makers in terms of epidemiology, economic analysis, vaccine performance, communication requirements and performance management.
  • As an outcome, students should be able to design a new vaccine programme introduction.

SESSION 1b - SPECIAL LECTURES FROM INDUSTRY

Debate on mandatory vs voluntary vaccination: 
  • To “break” ice on the first day, i.e. let all participants get involved and share views (as almost all have an opinion on the matter)
  • To increase understanding how definition / context / vaccine / age / time specific such a decision is
  • To increase understanding on what grounds and how pro/con rationales can be defended
  • By using pre-post debate-discussion voting, to demonstrate how opinions can be influenced
Role of DC Vaccine Industry for meeting global needs:  
  • To apprise the scientific community on the global vaccine supply scenario and specifically review the role of manufacturers based in developing countries in supplying the quality vaccines at affordable prices.
  • To discuss the impact of affordable vaccines, manufacturing capacities of developing countries vaccine manufactures on achieving some of major global health milestones
  • To review the role of some emerging developing country vaccine manufacturers in development and introduction of newer vaccines which are important in achieving expectations of international agencies as well as national governments.
Development of Vaccines for Global Use: the Role of the Pharmaceutical Industry:  

By the end of the lecture students will:

  • Be familiar with common valuation metrics used by large pharmaceutical companies in decision making processes to discern vaccine development projects that warrant further investment from R&D to clinical development and licensure from those that need to be discontinued. These include:
    • The expected Net value of a Vaccine Development Program
    • Probability of technical and regulatory success
    • Value Maximization Strategies: Accelerated Approvals and Life Cycle Opportunities
    • Epidemiological, programmatic and economic considerations to assess the potential commercial value of a new vaccine candidate
    • Vaccines Portfolio Management: the Productivity Index measure.
  • Be able to better grasp the strategic nuances associated with a particular vaccine investment opportunity and how these decisions should always be supplemented with management judgment including corporate social responsibility goals, portfolio balance and diversity objectives, and the necessity to maintain portfolio alignment with the corporate strategy, vision, and mission.

 

DAY 2

SESSION 2 - HOW VACCINES WORK

 
How are vaccine responses elicited? 

By the end of this lecture, the participants should be able to:

  • understand where and how vaccine B and T cell vaccine responses are elicited
  • identify the key factors that increase or reduce the magnitude of vaccine responses
  • apply this generic understanding to specific vaccines and issues of interest.
Use and limitations of correlates of immunity in vaccinology:  
  • Provide insight into the different definitions of correlates/surrogates that are used.
  • Understand how correlates have been derived and what is measured.
  • Understand how correlates of protection can accelerate development, licensure and implementation of vaccines.
  • Realise that efficacy data might be needed and this could be challenging.
Vaccines and mucosal immunity:
  • To explain the importance of mucosal immune responses for vaccine indirect/population-wide effects.
  • To explain the practical and operational barriers to wider understanding and usage of mucosal immune responses to vaccines.
  • To provide examples of vaccine programmes that work via indirect effects and how these can influence programme design.
  • To describe the immunological mechanisms that are considered to underlie mucosal responses to vaccines.
Vaccines and immunological memory:  

Quiz and general discussion
During this session, the participants will be invited to apply epidemiological and vaccine immunology concepts to specific situations of immunization failures.

Advances in vaccine and immunization technologies: 
  • To learn about technologies that are currently utilized for vaccine design, manufacturing, delivery, stabilization and evaluation
  • To get specific examples of how different technologies are being utilized to address different challenges in vaccine development
  • To learn about the stage of development of different vaccine technologies
Immunological memory
  • Define immunological memory and demonstrate its practical importance.
  • Describe the mechanisms involved in B cell memory with the example of influenza.
  • Describe the mechanisms involved in T cell memory with related examples.
  • Define the different steps in building immunological memory and the potential effect of adjuvants or live vaccines on immunological memory.

 

DAY 3

SESSION 3 - DECISION-MAKING IN VACCINE RESEARCH AND PRECLINICAL DEVELOPMENT

 
How do vaccines cause adverse events? 

After participation in this discussion, participants will be able to:

  • Identify the pathogenic mechanisms involved in adverse events caused by vaccines.
  • Explain how live vaccines can cause uncontrolled infections in immunocompromised individuals.
  • Explain how the injection process can result in shoulder injuries.
  • Prevent preventable adverse events associated with immunizations.
Vaccine Adjuvants:  
  • Provide participants with an understanding of why adjuvants are included in vaccines and the benefits and risks they bring.
  • Provide participants with an overview of the different adjuvants that are used or in development, and the relative pros and cons to each of these adjuvants.
  • Provide participants with general guidance on which adjuvants to consider when developing vaccines.
From preclinical research to vaccine development: examples of go-no-go decisions:
  • Present the main activities in Pre-Clinic leading and including Ph 1, First-in-Human, with example of Go and No Go decisions.
  • The early development of a vaccine candidate against HCMV serves as leading example..
Dengue vaccines
  • Discuss the complexities of dengue virus vaccine development including the need for protection against 4 separate dengue viruses and the role of antibody dependent enhancement of infection in more severe dengue disease.
  • Review the Phase 3 clinical trial results of Dengvaxia™, the first licensed dengue vaccine.
  • Discuss the possible causes of the failures of Dengvaxia™ and how they have informed other dengue vaccine manufacturers.
  • Update other dengue vaccines currently in Phase 3 clinical trial.
Round table debate:  Regulatory considerations 

The purpose of this panel is to provide this diverse audience with a "stimulating" perspective of the complexity of decision-making and competing perspectives involving key players (governmental regulatory and industry) in licensing of vaccines.  In addition to providing base information as to the roles and responsibilities of these parties, we try to bring into play current topical issues that add additional complexity, relevant to the current state of vaccine development.  Ample time is allowed for class participation and discussion around other regulatory topics.  

The regulatory perspective from the US FDA point of view will be provided, and the objective is to convey to the students how regulators interact with the regulated industry, and the deliberations that a regulator must go through in making decisions on evaluating and licensing new vaccines. 

The complexity of quality control in vaccine manufacturing:
  • Describe the different steps involved in the manufacturing of vaccines.
  • Make people aware of the complexity of quality control during and after manufacture including the regulatory environment.
  • Explain the complexity of any process modification during manufacture and make people understand why shortages of vaccines can be an issue and why it is not easy to solve it.
Debate:  Dealing with human challenge studies
  • The objective of this debate is to update about the use of HCT (Human Challenge Trials), weigh the pros and cons and look to the way forward.
  • Human vaccines require huge, costly and long phase II and phase III trials to confirm, or not, safety and efficacy of new vaccines. The efficacy poses particular problem. The lack of correlates of protection increases the size and time of phase III trials. However, the ideal situation to evaluate the efficacy of a vaccine is to vaccinate the “target species”, human in this case, and then challenge it. As the long experience in animal health learns, this is an excellent indicator of efficacy or non- efficacy of a vaccine.
  • The debate will try to clarify:
    • state of the art of HCT
    • ethical concerns of HCT
    • progress made to deal with ethical concerns with examples to date
    • what degree of safety and efficacy data can be obtained by HTC?
    • capacity of HTC for down selection of vaccine candidates
    • can HTC reduce the volume and time of clinical trials?
    • balance ethics and need, benefit risk

 

DAY 4

SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (I)

 
Clinical trials: an overview of issues to be considered

After this lecture, course attendees will:

  • See how clinical trials fit into the progression of vaccine development leading step-wise to licensed products.
  • Have a clear recognition of the vaccine clinical development paradigm by which a vaccine progresses from Phase 1, to Phase 2 to Phase 3 pre-licensure trials and the role of post-licensure Phase 4 studies.
  • Appreciate how the design and performance of clinical trials have changed over the decades, increasing in sophistication and complexity.
  • Be familiar with the various options that may, or may not, be available to demonstrate the efficacy of a vaccine in Phase 3 trials on a track for licensure by regulatory agencies.
Defining sample size of a vaccine trial
  • Concepts of statistical significance and statistical power of a trial.
  • How these are used in determining the size of a vaccine trial.
  • Choice of efficacy level a trial is designed to detect.
  • Vaccine: placebo ratios other than 1:1.
  • Powering trials based on lower confidence bound of efficacy.
  • Non-inferiority trials.
  • Non-statistical factors to consider when planning trial size.
Small group exercise 1: How to design, recruit volunteers for, and analyse the results of selected phase II trials

Phase II study design: to familiarize the participants on what are all the key elements that go into the development strategy of a new vaccine, and what kind of decisions the vaccine developer will have to make in the different phases of development. The participants are asked to concentrate into designing a phase II trial, but this needs to be viewed in the light of the entire clinical development plan. Objectives are reached via several methods: either facilitated discussion, group work or role play, depending on the leader of this group work.

Using Dengue vaccine as a model:

  • The objective will be to design a phase II protocol for the evaluation of Dengue vaccine.  This will involve determining the objective(s), and stated purpose of the clinical trial; how to recruit volunteers, including developing inclusion/exclusion criteria; and determining the appropriate number of participants to support the objective of the clinical trial, and how the data from the trial will be analyzed.
Assessing herd protection and vaccine effectiveness (and use for licensure)
  • To understand the different mechanisms by which vaccine herd protection can occur
  • To appreciate the role of observational studies in assessing vaccine herd protection
  • To understanding new methodological approaches for measuring vaccine herd protection in cluster-randomized and individually randomized clinical trials.
  • To appreciate the role of measuring vaccine herd protection in assessing vaccine cost-effectiveness
Clinical trials: role of DSMB (with several examples of intervention)
  • To understand why DSMBs are important in vaccine clinical trials.
  • To know under what clinical trial scenarios a DSMB is needed.
  • To know how to implement a DSMB including membership, charter, and relationship with other committees.
The 4th LAMBERT LECTURE:  Challenges and prospects for new tuberculosis vaccines
  • To understand the limitations of BCG.
  • To understand the challenges in TB vaccine development.
  • To understand the current status of the field.
  • To understand some of the innovative approaches in the field to overcome the challenges.

 

DAY 5

SESSION 5 - VACCINE SAFETY - ASSESSMENT OF ADVERSE EFFECTS

 
Lessons learned from previous adverse effects of vaccination and causality assessment

After participation in the discussion, participants will be able to:

  • Investigate adverse events reported following immunizations and collect the information necessary to determine the likelihood of a causal relationships.
  • Evaluate the likelihood of a causal relationship between the vaccine and reported adverse events using standard guidelines.
  • Report adverse events possibly associated with immunizations.
Vaccination and autoimmune disease
  • To highlight the present understanding of mechanisms which regulate immune responses to self-antigens and prevent related autoimmune diseases.
  • Define the level of evidence for a putative autoimmune pathological process claimed to be associated with a particular vaccination.
  • Define a logical analytic process to assess the causality of a suspected autoimmune adverse effect, with an in-depth analysis of the specific case of narcolepsy following the use of an adjuvanted influenza vaccine during the 2009 pandemic outbreak.
  • Define approaches to assess the risk of autoimmune manifestations with newly developed vaccines.
Population-based post-licensure surveillance
  • To understand the role of vaccine -pharmacovigilance and epidemiological studies in safety assessment.
  • To see how this is done in different settings with examples.
  • To know the main study designs used for safety assessment.
  • To specifically focus on the self-controlled case-series design, its benefits, and when it can be used.
Vaccination and narcolepsy
  • To describe the process of identifying a rare severe adverse event in relation to an adjuvanted pandemic vaccine (signal detection).
  • To describe the different processes of validating the signal from a country and international perspectives.
  • To analyze the impact of such an unexpected safety event on vaccine development and uptake.
Immunization safety in low and middle income country vaccination programs
  • To understand the range of potential immunization safety issues.
  • To understand the real problems and challenges.
  • To review differences between low and middle income and high income countries.
  • To present the range of actions to ensure immunization safety including injection safety and waste management.
  • To present WHO's activities in support of global immunization safety.
Vaccine hesitancy and risk communication through the lens of HPV vaccine

Using the example of HPV, following this presentation, the participant will be able to:  

  • Define vaccine hesitancy and the continuum to refusal.
  • Identify and list factors that contribute to hesitancy in different contexts with different vaccines.
  • Outline evidence informed strategies for addressing hesitancy and improving vaccine acceptance at the program and patient levels.
  • Describe key factors (and pitfalls) in developing immunization program and patient communication strategies.
  • Identify why supporting vaccine acceptance resiliency is important.

SESSION 6 - ASSESSING VACCINES IN CLINICAL TRIALS (II)

Statistical assessment and reporting of Phase 3 trials
  • Reference CONSORT guidelines for reporting trials.
  • Introduce concept of statistical analysis plan.
  • Present simple analysis methods for 2-arm trial.
  • Discuss practical statistical analysis issues in trials with variable follow-up periods.
  • Discuss “per protocol” and “intention to treat” analyses.
  • Discuss issues in sub-group analysis.
  • Discuss adjusting for confounding variables.
  • Trial designs considered for Ebola vaccines.
  • Case-control evaluation of vaccine effectiveness.
Small group exercise 2: Designing and analysing the results of selected phase III trials

The learning objectives of the exercise are:

  • To analyze the methodological aspects in the design of phase III vaccine trials which impact the outcome of the trial;
  • To understand the degree of completeness of reporting of phase III vaccine trials according to the CONSORT guidelines; and
  • To understand how to critically appraise and compare results arising from different randomized controlled trials.

DAY 6

SESSION 7 - ETHICAL ISSUES

 
Principles, guidelines and framework for ethical considerations in clinical trials of vaccines
  • To examine ethical complexities in vaccine trials using various resources (ethics guidance; ethics frameworks; empirical data) e.g. ‘community’ participation; informed consent
  • To make recommendations for researchers planning and implementing vaccine trials
  • To provide ADVAC course attendees with some ‘tools’ with which to participate in an interactive ethics exercise
Applied ethics in immunization programs and practice

In the context of an immunization program and a HCP’s immunization practice, following this presentation, the participant will be able to,  

  • Identify key factors in obtaining consent for immunization in different settings  
  • Outline ethical issues in financing and access to immunization 
  • Describe the ethical basis for and against mandatory immunization laws
  • Outline the ethical issues of dismissing patients from practice if choose not to immunize
  • Identify why reporting of AEFI and feedback to HCW and patient /family is required for ethical practice
  • Identify why not supporting pain mitigation on immunization is unethical
Small group exercise 3:  Ethical considerations in malaria vaccine trials

Via the method of role play the participants will gain a deeper understanding of ethical issues related to vaccines and vaccine trials. These will be addressed via issues arising from the trial and study objectives, setting and participants’ health status as well as issues related to world view and religion.

 

DAY 7

SESSION 8.1 - INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMMES (1)

 
Disease burden and the public health value of vaccines

At the end of the session, students will be able to:

  • Assess the public health value of vaccines beyond efficacy and safety
  • Explore measures and outcomes to define the public health value of vaccines
  • Calculate vaccine preventable disease incidence and number needed to vaccinate
  • Develop a public health value proposition for vaccines
  • Define total systems effectiveness.
Quantitative vaccine policy: integrating science, economics for public health policy

 « Health economics (incl. modelling) as a tool in analysing vaccine policy » is the original title 

  • Integrate biomedical, epidemiology and economic data to explicitly assess the value of health outcomes associated with vaccine benefits and costs to assess:
    •  Insurance policy for individuals
    •  Justify investments for public vaccine program.
  • Provide a decision analytical framework to systematically evaluate choices of vaccine policy.
  • Evaluate uncertainty which guides a research agenda.
Challenges and solutions in making evidence-based national vaccination policies and recommendations

Participants will be provided with insight on:

  • How to make the best evidence-based national vaccination policies and recommendations: context, challenges and solutions
  • The importance and the role of National Immunization Technical Advisory Groups (NITAGs)
  • The recommended structure and functioning of NITAGs
  • Issues to be taken into consideration for the development of evidence-based recommendations
  • A framework for the development of evidence-to-recommendations
  • Considerations related to the development of off-label recommendations.
  • Approaches to evaluate the functioning of NITAGs
  • The status of development of NITAGs globally
  • Challenges and solution to establish and strengthen NITAGs.
Immunization coverage gaps: overcoming the chronic challenges
  • Identify the current global targets, achievements and challenges with respect to immunization coverage.
  • Review the current major barriers to increasing or maintaining immunization coverage (weak health systems, missed opportunities, vaccine shortages, vaccine hesitancy, disruption of immunization, availability of quality data).
  • Identify best practices to increase vaccination coverage.
  • Review some options to simplify and facilitate vaccine delivery.
  • Identify important elements to implement vaccination in humanitarian emergency situations.
Response to polysaccharides and conjugates vaccines: basic aspects
  • Understand the role of bacterial capsular polysaccharides.
  • Understand the interaction between the human immune system and bacterial polysaccharides.
  • Understand the molecular basis for the improved response to conjugate vaccines.
Pneumococcal conjugate vaccines in children and adults: Efficacy and limitations of available vaccines 
  • Understand adult pneumococcal disease epidemiology in settings with and without infant PCV programs.
  • Review pneumococcal vaccine options, characteristics, and immunogenicity including PCV and PPS23.
  • Review adult pneumococcal vaccine use, impact on disease, transmission with a focus on limitations and future opportunities.
  • Describe the existing pneumococcal conjugate vaccines, including those likely to be licensed in the near future.
  • Describe the variety and endpoints expected to be impacted by PCV in children, including nasopharyngeal carriage.
  • Describe the basics of serotype replacement post-PCV.
  • Discuss the extent and importance of indirect protection with PCVs.
  • Discuss efficacy vs. impact of PCVs on vaccines endpoints (IPD, mucosal diseases, antibiotic resistance).
  • Discuss expectations vs. observations in PCVs (The “vaccine probe” concept).
  • Discuss potential limitation with the current PCVs.
Pneumococcal conjugate vaccines: Existing and potential vaccination strategies
  • Understand the relationship between pneumococcal disease in adults and children.
  • Appreciate the impact of PCV immunization in children on disease burden in unvaccinated populations.
  • Stimulate thinking about the possibilities of future vaccine strategies designed to maintain herd rather than individual protection.
Non-specific effects of vaccines

To present the participants with:

  • A summary of the epidemiological evidence that suggests NSE exist.
  • A critical evaluation of the evidence for and against related hypotheses - e.g. gender-specific effects, live and non-live vaccine effects.
  • Gaps and limitations in current knowledge e.g. mechanisms/details of apparent effects on mortality.
  • Examples of immunological evidence for NSE in animals and humans.
  • Strategies that have been proposed for advancing knowledge in this field that may permit NSE to be used to generate public health benefits.
Does a vaccine have to protect against a VPD that kills to matter to politicians and parents?  
A debate

 

DAY 8

SESSION 8.2 - INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMMES (2)

 
Influenza biology, new vaccines and vaccination strategies for different age groups
  • To review seasonal and pandemic influenza.
  • To review the currently available influenza vaccines, their advantages and limitations.
  • To discuss tools and strategies to facilitate influenza prevention through vaccination in low- resource settings (includes maternal and pediatric examples).
Vaccine responses and efficacy in the elderly (including the example of the Zoster vaccine) 
  • Describe the changes in the aging immune system.
  • Understand the changes in disease burden in older adults.
  • Know the limitations of vaccines in the elderly.
  • Describe the purpose of vaccines in older adults.
Population biology of bacterial pathogens in vaccinology
  • To highlight the importance of why understanding population biology of bacteria matters including its role in selecting vaccine antigens and in assessing vaccine effectiveness.
  • Describe the basis of variability in bacterial populations over time and in different geographical locations; the role of mutation, lateral gene transfer and transmission dynamics, including population bottlenecks.
  • Emphasise how whole genome sequencing of bacterial pathogens has revolutionised epidemiology.
  • Why understanding the population structure of carriage and disease isolates is important in the context of direct and indirect protection by vaccines.
  • In depth analysis of specific pathogens, including Bordetella pertussis and Neisseria meningitidis, to illustrate the major points outlined above.
Meningococcal vaccines
  • The benefits of conjugate over polysaccharide vaccines.
  • The importance of understanding carriage dynamics.
  • The difference between direct and indirect immunity and importance of herd protection.
  • The importance of whole genome sequencing in monitoring spread of meningococci globally.
  •  Understanding the new sub-capsular vaccines for serogroup B disease.
Success and challenges with rotavirus and norovirus vaccines
  • Understand the global burden of rotavirus and norovirus diarrhea and the value of vaccination.
  • For rotavirus vaccines, review the progress with implementation of vaccination programs, including post-licensure impact and safety data.
  • For norovirus vaccines, review the progress with vaccine development.
  • Discuss the remaining issues and challenges for full prevention and control of these diseases.
Small group exercise 4:  Decision-making for the evaluation and impact assessment of new vaccines introduced in selected countries safety and effectiveness. 
  • To learn how to best organize data needed for a policy decision to introduce a new vaccine in a country – identifying what data are available and needs for further data collection.
  • To learn how to develop structured monitoring of vaccine safety and effectiveness following introduction of a new vaccine– options to be discussed.
  • To present to the MoH in an oral 2-3 minute presentation the rationale for introduction of the selected vaccine to the selected target groups.

The participants get to choose a particular vaccine in a specific country setting. Six different scenarios will be available for the participants to sign up. At the end of the exercise, each group will choose a representative of the group who will present the outcome to the MoH.

History of vaccines and vaccination
  • To identify the people whose work led to the use of important vaccines.
  • To note the changes in vaccine technology that have occurred over the last 200 years.
  • To mention some of the historical controversies.

 

DAY 9

SESSION 9 - SELECTING APPROPRIATE VACCINATION STRATEGIES

 
Vaccination and pregnancy: scientific basis, main issues and applications - Optimizing infant protection through maternal immunization
  • Understand mechanisms of maternal antibody transfer across the placenta in healthy women and the potential for decreased transfer to those with underlying medical conditions such as HIV or malaria.
  • Understand when, where, and why maternal immunization should be considered.
  • Describe the impact of maternal immunization on the prevention of neonatal tetanus, pertussis, and influenza disease.
  • Appreciate potential pathogens and vaccines that may be suitable for maternal immunization
Vaccination in early life

By the end of this lecture, the participants should be able to:   

  • be aware of the unique challenges associated with immune responses in early life
  • understand the basic principles that shape early life immune / vaccine responses 
  • apply this understanding to that of infant vaccine schedules.
Vaccination schedules: past, present and future – is there some rationale?  
  • To understand the critical elements of how immunization schedules have been designed in the past, now and in the future.
  • To critically analyze the paradigms of immunization schedule research, design and implementation.
  • To identify the conditional elements and challenges faced by immunization schedules around the world.
Special Lecture:   The challenge of malaria vaccines and of their potential introduction
  • Understand the key role of non-vaccine measures in malaria control.
  • Gain insight to the different targets/life cycle stages for malaria vaccines and understand how immune responses to different parts of the life cycle have different clinical implications.
  • Be updated on the status of the malaria vaccine pipeline.
  • Be updated on the status of the malaria vaccine pilot implementation programme.

Parallel working group sessions:

National decision-making for immunization programmes
  • Identify factors that should be considered in making recommendations.
  • Identify the key stakeholders and how they interact with NITAGs and discuss their role in decision making (including NRAs, industry, medical societies, CSOs...).
  • Describe factors affecting the credibility and performance of NITAGs.
  • Describe proposed self-evaluation process to determine the effectiveness of NITAGs.
  • Allow for any additional specific discussion of interest to participants.
Clinical vaccinology:  patients' problem solving

During this interactive session, the participants will apply their vaccine immunology skills to the solving of clinical vaccinology complex situations including:

  • how to catch-up missing vaccines
  • how to deal with potential vaccine-induced adverse events
New approaches towards vaccination e-registries
  • To acquire an understanding of organization and funding needed for development and maintenance of electronic immunization registers.
  • To acquire an understanding of the minimum data set for an electronic immunization register to collect data on vaccines provided.
  • To acquire understanding on the different uses of such a register on individual and population level (a. to generate reminders and recall vaccination notices for each client, to provide official vaccination forms upon request for the individual, and b. to allow vaccination coverage and timeliness assessments and comparisons across regions).
  • To acquire an understanding of the possibilities for data linkage of different electronic health care databases (vaccine impact assessment, both effectiveness and safety).
  • To understand the implications of data protection laws when setting up and using the e-immunization registers.
SPECIAL LECTURE: The 12th PLOTKIN LECTURE: 
  • CEPI and emerging diseases

 

DAY 10

Vaccines for the immuno-compromised (IC) patient
  • Describe safety concerns of vaccines in the IC patient.
  • Understand mechanisms as to how vaccines can be effective in patients with different immunocompromised states.
  • Devise individualized vaccine plans for patients pre- and post-transplantation, with HIV, or congenital immunodeficiencies.
10 years of HPV vaccines: successes, setbacks, where next?   

At the end of this lecture the audience should understand and be informed about:

  • Burden of disease, need for prophylactic HPV vaccines, composition of current products, dosage schedules, cohorts for immunisation, mechanism of action of current vaccines
  • Current data on vaccine impact and effectiveness – disease, virus prevalence, herd immunity. Determinants of this.
  • Vaccine confidence- impact on new and established HPV vaccine programmes.
  • Contemporary debates – one dose regimen, elimination of vaccine HPV types.
CMV vaccines in development
  • To describe the reasons a CMV vaccine is needed.
  • To describe the different technologies being proposed to make a CMV vaccine.
  • To describe the state of vaccine development.
Global challenges for pertussis vaccines
  • Understand the components of the whole cell and acellular vaccines and their comparative efficacy for the prevention of laboratory confirmed disease in infants.
  • Discuss both the global burden of pertussis disease and vaccine coverage rates.
  • Discuss the emergence of pertussis disease in countries with acellular vaccine programs.
  • Review the baboon model and what it tells us about the impact of vaccine on disease transmission.
  • Review maternal immunization programs and their impact on infant disease.
  • Discuss the immunologic responses to both acellular and whole cell pertussis vaccines and why matter.
  • Propose solutions to the problems with the current pertussis vaccines.
HIV vaccines 
  • To explain the need for and review the challenges of designing an HIV vaccine.
  • To briefly explain NHP models of HIV infection.
  • To review passed HIV vaccine approaches and completed efficacy trials.
  • To describe main current approaches for the development of an efficient HIV vaccine.
  • To review current HIV vaccine efficacy trials.
  • To review the different paths towards elicitation of broadly neutralizing antibodies through vaccination.
  • To explain how broadly neutralizing antibodies develop in a fraction of HIV-infected individuals
Progress with RSV and Zika vaccines: how technologies can change viral vaccine development
  • Understand the concept of structure-based vaccine design and status of RSV vaccine development
  • Learn about class I fusion proteins as a vaccine target across virus families
  • Know the current status of ZIKV vaccine development and remaining obstacles
  • Identify new technologies that may allow more rapid vaccine development
Outbreaks’ control: Elimination and eradication strategies
Polio
  • Assess the progress made so far towards global polio eradication and analyze the unique socio-political, and epidemiologic challenges in remaining endemic areas.
  • Interpret the evolving clinical evidence base on polio vaccines and assess how it impacts vaccination policy for the Endgame and beyond.
Diphtheria, Measles and rubella: 
  • Provide a historical representation of measles and rubella elimination efforts globally.
  • Explore issues related to the elimination feasibility – biological, epidemiologic, and economic.
  • Preview options under consideration for future elimination and eradication efforts
  • Identify the reasons for the continued occurrence of outbreaks of VPDs such as diphtheria and strategies to control these.
Vaccine research in low and middle-income countries: the example of rotavirus
  • How to anticipate the last mile for the control of rotavirus with vaccines?
  • Vaccine introduction as a mass population experiment: What surprises may be in store?
  • For high income countries, the challenge of vaccine pricing vs. coverage?
  • Reassessing the decision to withdraw Rotashield: What would you have done today?
  • Do we need a next generation vaccine for Rotavirus?

 

DAY 11

SESSION 10 - FACING THE MEDIA

 
Introduction to media dynamics: how to best deliver vaccinology-related messages to different interest groups

In this highly interactive session, you will learn how to approach media interviews with increased confidence. 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 training objectives:

  • Discover how people perceive confidence in others & make judgements using emotions, rather than facts
  • Identify your professional Brand Values
  • Project confidence, expertise & personal warmth through body language, voice & words
  • Appear (and sound) more authoritative and trustworthy
  • Match your image to your Brand Values (allowing for cultural differences)
  • Bring science to life – make it real for people
  • Learn the ABC technique for media interviews
  • Win hearts as well as minds
  • Calm your nerves and ‘anchor’ your confidence.