10.09.2012 11 th ADVANCED COURSE OF VACCINOLOGY- 2010 MONDAY 10 MAY 2010 Theme Coordinator : Adam Finn (Bristol, UK) 09 :00 Opening Benoit Miribel, General Director, Fondation Mérieux 09 :15 Definition of the course objectives Paul-Henri Lambert, Director of the ADVAC Course SESSION 1.- THE MULTIFACETED NATURE OF VACCINOLOGY Chairpersons: Claire-Anne Siegrist, and Paul-Henri Lambert 09:40- Opening Lecture: Stanley Plotkin, University of Pennsylvania 10:20 The history of vaccinology and its global perspectives 10:20- Discussion 10:40 10:40- Break 11:10 11:10- Impact of vaccination on disease epidemiology Roy Anderson, Imperial College, London, UK 11:55 11:55- Discussion 12:20 12:30- Lunch 14:00 14:00- Herd immunity John Clemens , IVI, Korea 14:30 14:30- Discussion 14:50 14:50- Public and media perception of vaccination during the David Salisbury , UK 15:20 course of the H1N1 pandemics 15:20- Discussion 15:40 15:40- Break 16:00 16:00- The Value of Vaccination Till Baernighausen , Harvard PHS 16:30 16:30- discussion 16:50 18 :00 Welcome reception 1 10.09.2012 Theme Coordinator : Adam Finn (Bristol, UK) TUESDAY 11 MAY 2010 SESSION 2 - HOW VACCINES WORK Chairpersons: Adam Finn and Daniel Pinschever (UNIGE) 09:00-09:30 How are vaccine responses elicited? Claire-Anne Siegrist , University of Geneva What a vaccinologist should know about the basic aspects of immunological responses a- B-cell responses 09:30-10:00 Discussion 10:00-10:30 Break 10:30-11:00 What a vaccinologist should know about the basic aspects of immunological responses Claire-Anne Siegrist , University of Geneva b- T-cell responses 11:00-11:30 Discussion 11:30-12:00 Immunological correlates of immunity: use and limitations in vaccinology: Stanley Plotkin , University of Pennsylvania, Philadelphia 12:00-12:20 Discussion Lunch 14:00-14:30 Immunological basis for responses to mucosal vaccines Adam Finn , University of Bristol 14:30-14:50 Discussion 14:50-16:00 Vaccines and Immunological memory Claire-Anne Siegrist , University of Geneva Quiz and general discussion 16:00-16:20 Break 16:30-17:10 Vaccine-induced Immunological memory Rafi Ahmed , Emory University 17:10-17:30 Discussion 2 10.09.2012 WEDNESDAY 12 MAY 2010 Theme Coordinator : Hanna Nohynek (THL, Helsinki) SESSION 3 – DECISION-MAKING IN VACCINE RESEARCH AND PRECLINICAL Chairpersons : Luc Hessel & Georges Thiry DEVELOPMENT 09:00-09:30 Vaccine adjuvants: pragmatic approaches Martin Friede , WHO, Geneva 09:30-09:50 Discussion 09:50-10:20 From pre-clinical research to vaccine development: Examples of go-no-go decisions Georges Thiry , PATH 10:20-10:40 Discussion 10:40-11:00 Break 11:00-11:30 How do vaccines cause adverse events ? Neal Halsey , Johns Hopkins B. School of Public Health, Baltimore 11:30-11:40 discussion 11:40-12:10 Special Lecture: HIV vaccines Brigitte Autran , INSERM, France 12:10-12:30 Discussion Lunch SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (I) Chairpersons: Hanna Nohynek 13:30-14:10 Sequential stages of clinical trials and overview of issues to be considered Myron Levine, University of Maryland, Baltimore, USA 14:10-14:30 Discussion 14:30-17:00 Regulatory barrier s e.g. re:new adjuvants Norman Baylor (FDA), Pieter Neels (Federal Agency for Medicinal and Health Round table debate Products Brussels & CHMP-EMEA ) – Thomas Verstraeten , GSKBio and Michael Decker (Sanofi Aventis,) 17:00-17:30 Lessons from pitfalls experienced in the registration process (including role of a DSMB) Luc Hessel , Sanofi Pasteur MSD, Lyon, 17:30-17:45 Discussion 3 10.09.2012 Theme Coordinator : Hanna Nohynek (THL, Helsinki) THURSDAY 13 MAY 2008 SESSION 5 - ASSESSING VACCINES IN CLINICAL TRIALS (II) Chairperson: Juhani Eskola 09:00-09:30 Essential practical aspects in conducting phase III trials Hanna Nohynek , Helsinki 9:30-09:45 Discussion 09:45-10:05 Break 10:05-10:35 Introduction to statistical aspects of clinical trials Peter Smith , LSTMH, UK 1- Defining sample size: practical approaches and examples 10:35-10:55 Discussion 10:55- 12:40 How to design, recruit volunteers for, and analyze the results of selected phase II trials 14:00- 15:00 Small group exercise: How to design a phase II trial - Group 1: Group 2: - Group 3: Group 4: Group 5: Statistical approaches-exercise- Group 6: - 12:40-13:10 lunch buffet Special lectures: New vaccines in development (1) 15:00-15:30 New approaches to vaccine development and delivery systems Carole Heilman, NIH/NIAID Discussion 15:50-16:20 The challenge of developing new tuberculosis vaccines Stefan Kaufmann (Berlin) Discussion Break 17:00-17:30 The challenge of malaria vaccines- Vasee Moorthy WHO Discussion 4 10.09.2012 FRIDAY 14 MAY 2010 Theme Coordinator : Neal Halsey (Baltimore) SESSION 6 – VACCINE SAFETY - ASSESSMENT OF ADVERSE EFFECTS Chairpersons: Noni Mc Donald and Neal Halsey 08:45-09:15 Lessons from previous adverse effects of vaccination and Assessment of causal relationships Neal Halsey, Johns Hopkins B. School of Public Health, Baltimore 09:15-09:35 Discussion 09:35-10:05 Immunological safety of vaccination ( Autoimmune and allergic diseases) Paul-Henri Lambert, 10:05-10:25 Discussion 10:25-10:40 Break 10:40-11:10 Immunization safety in developing country vaccination programs Philippe Duclos , WHO 11:10-11:30 Discussion 11:30-12:00 Risk communication: An overview Noni McDonald , Dalhousie Univ, Halifax Canada 12:00-12:20 Discussion Lunch 13:30-14:00 Introduction to statistical aspects of clinical trials- Peter Smith , LSTMH, UK 2- Statistical assessment of phase 3 trials- 30 min 14:00-14:20 Population-based post-licensure surveillance Steve Black, Cincinnati Children's Hospital Medical Center 14:20-14:50 Discussion 14:50-15:10 Discussion 15:15-18:00 Small group exercise 2: Designing and analysing the results of 3 selected phase III trial Objective: To understand how to critically appraise and compare phase III (pneumococcal conjugate vaccine in The Gambia, among Navajo Indians in the U.S. and in trial results South Africa ) Introduction to the group work Exercise: Hanna Nohynek Group 1:- Facilitator: Edwin Asturias Group 2: - Facilitator: Hanna Nohynek Group 3: - Facilitator: Steve Black Group 4: - Facilitator: Rana Haji Group 5: - Facilitator: Peter Smith 5 10.09.2012 Theme Coordinator : Edwin Asturias (Guatemala City) SATURDAY 15 MAY 2010 SESSION 7- ETHICAL ISSUES Chairpersons: Betty Dodet and Catherine Slack Ethical issues related to clinical trials – Revisiting the Helsinki Declaration 08:45-09:20 Clinical trials in developing countries: Ethical issues Catherine Slack (University of KwaZulu-Natal, South Africa) basic principles & practical approaches 09:20-09:40 Discussion 09:40-12:30 Small group exercise 3: Ethical issues – Access to treatment for participants who seroconvert Coordinated by Catherine Slack during the conduct of an HIV vaccine trial talk with her And Betty Dodet (Lyon) Group 1:- Facilitator: Hanna Nohynek Group 2: - Facilitator: Catherine Slack Group 3: - Facilitator: Noni McDonald Group 4: - Facilitator: Betty Dodet Group 5: - Facilitator: TBA Group 6: - Facilitator: Rana Haji 6 10.09.2012 Theme Coordinator : Mark Miller (Bethesda) MONDAY 17 MAY 2010 08:40-09:00 Review and conclusions of the 23 May Ethics session Cathy Slack SESSION 8.1- INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMMES Chairperson: Juhani Eskola Approaches to help the decision-making process 09:00-09:30 Integration of Science, Public Health and Economics - Critical Assessment of Vaccine Policy Mark Miller, Fogarty International Center Options 09:30-09:45 Discussion 09:45- Role of disease burden assessment in the decision-making process Brad Gessner AMP 10:15 10:15-10:35 Discussion 10:35-11:00 Break 11:00-11:30 Challenge of making evidence-based vaccination policies in developing countries Rana Hajjeh, CDC, 11:30-11:50 Discussion 11:50-12:20 Access to vaccines : economic aspects, GAVI and AMC Nina Schwalbe , GAVI 12:20- Discussion 12:40 12:40-14:00 Lunch Case-specific study #1: Meningococcal vaccines 14:00-14:30 Infant responses to polysaccharide and conjugate vaccines David Goldblatt , Institute of Child Health, London 14:30-14:50 Discussion 14:50-15:20 Approaches towards new Meningococcal vaccines 15:20-15:40 Discussion Giuseppe Del Giudice, Novartis Vaccines 15:40-16:00 Break 16:00-16:30 Future vaccination strategies to prevent meningococcal epidemics in Africa Brian Greenwood (UK) 16:30-16:50 Discussion 16:50-17:20 Special lecture: Richard Moxon, Oxford University The population biology of bacterial pathogens and its importance for vaccination strategies 17:20-17:40 Discussion - 7 10.09.2012 TUESDAY 18 MAY 2010 Theme Coordinator : Mark Miller (Bethesda) SESSION 8.2 - INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMMES (2) Chairperson: Alan Shaw (Vaxinnate) and Bernard Fritzell (Wyeth) Case-specific study #2: pneumococcal conjugates 08:45-09:45 Pneumococcal conjugate vaccines: overview Ron Dagan , Soroka Medical Center, Beer Sheva and Keith Klugman (Emory Univ) 09:45-10:10 Discussion 10:10-10:30 Break Case-specific study #3: Influenza- vaccination strategies and pandemic disease preparedness 10:30-11:00 Influenza biology and vaccination strategies Kathy Neuzil, PATH, Seattle 11:00-11:20 Discussion 11:20-11:50 Development of new influenza vaccines Kathy Neuzil , PATH, Seattle 11:50-12:10 Discussion 12:15-13:30 Lunch 13:30-14:00 Vaccines for pandemic response: a global vision Marie-Paule Kieny (WHO) 14:00-14:20 Discussion 14:20-14:50 Varicella and Zoster vaccines: what are the issues ? Myron Levin UCD Denver 14:50-15:10 Discussion 15:10-15:40 Case-specific study