12.01.2010 TENTH ADVANCED COURSE OF VACCINOLOGY- 2009 MONDAY 18 MAY 2009 08:45-09:05 Opening Benoît Miribel, General Director, Fondation Mérieux 09:05-09:30 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 Pierre VanDamme 09:30-10:10 Opening Lecture Roy Anderson, Imperial College, London, UK Impact of vaccination on disease epidemiology 10:10-10:30 Discussion 10:30-11:00 Break 11:00-11:30 Are vaccines always cost-effective? Pierre VanDamme , University of Antwerp, Belgium 11:30-11:50 Discussion 11:50-12:30 Sequential stages of clinical trials and overview of issues to be considered Myron Levine, University of Maryland, Baltimore, USA 12:30-12:50 Discussion 13:00-14:30 Lunch 14:30-15:00 Herd immunity John Clemens , IVI, Korea 15:00-15:20 15:20-15:50 Public perception of vaccination: importance in new vaccination strategies David Salisbury Department of Health, London, UK 15:50-16:15 Discussion 16:15-16:45 Industry Views on Future Vaccines for the Global Community Jean Stephenne, President & CEO , GSKBio, Belgium 16:45-17:15 discussion 17:15-17:45 Prospects of DC manufacturers for globally used vaccines Suresh Jadhav, Serum Institute of India discussion 18 :15 Welcome reception 1 12.01.2010 TUESDAY 19 MAY 2009 SESSION 2 - HOW VACCINES WORK Chairpersons: Adam Finn and Paul-Henri Lambert 09:00-09:30 1. 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 Claire-Anne Siegrist, University of Geneva responses b- T-cell responses 11:00-11:20 Discussion 11:20-11:50 Immunological basis for responses to mucosal vaccines Adam Finn, University of Bristol 11:50-12:20 Discussion 12:25-14:00 Lunch 14:00-14:30 Vaccine adjuvants: pragmatic approaches Martin Friede, WHO, Geneva 14:30-14:50 Discussion 14:50-16:00 3.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 12.01.2010 WEDNESDAY 20 MAY 2009 SESSION 3 – DECISION-MAKING IN VACCINE RESEARCH AND Chairpersons: Luc Hessel & Georges Thiry PRECLINICAL DEVELOPMENT 09:00-09:30 How do vaccines cause adverse events ? Neal Halsey, Johns Hopkins B. School of Public Health, Baltimore 09:30-09:50 Discussion 09:50-10:20 From pre-clinical research to vaccine development: Examples of go-no-go Georges Thiry ( PATH) decisions 10:20-10:40 Discussion 10:40-11:00 Break 11:00-11:30 Immunological correlates of immunity: use and limitations in vaccinology: Stanley Plotkin, University of Pennsylvania, Philadelphia and Sanofi Overview Pasteur 11:30-11:40 discussion SESSION 4 - ASSESSING VACCINES IN CLINICAL TRIALS (I) Chairpersons: 11:40-12:20 Lessons from pitfalls experienced in the registration process (including role of Luc Hessel, Sanofi Pasteur MSD, Lyon, a DSMB) 12:20-12:40 Discussion 12:40-14:00 Lunch 14:00-14:30 Introduction to statistical aspects of clinical trials Peter Smith , LSTMH, UK 1- Defining sample size: practical approaches and examples 14:30-14:50 Discussion How to design, recruit volunteers for, and analyze the results of selected phase II trials 15:50-17:30 Small group exercise: How to design a phase II trial - Group 1: rotavirus – Group 2: Cholera (or Shigella) - Group 3: HPVl Group 4: Combos Group 5: Pneumo Group 6: HIV - 17:30-18:00 Special Lecture: Stanley Plotkin, The history of vaccinology and its global perspectives 18:00-18:20 discussion 3 12.01.2010 THURSDAY 21 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 09:45-10:15 Break 10:15-12:30 Small group exercise 2: Designing and analysing the results of 3 selected Objective: To understand how to critically appraise and compare phase phase III trial (pneumococcal conjugate vaccine in The Gambia, among Navajo III trial results Indians in the U.S. and in South Africa ) Introduction 15 min Juhani Eskola & Hanna Nohynek Introduction to statistical aspects of clinical trials- Peter Smith , LSTMH, UK 2- Statistical assessment of phase 3 trials- 30 min Introduction to the group work Hanna Nohynek Exercise: Group 1:- Facilitator: Edwin Asturias Group 2: - Facilitator: Hanna Nohynek Group 3: - Facilitator: Steve Black Group 4: - Facilitator: Group 5: - Facilitator: Peter Smith Group 6: - Facilitator: Juhani Eskola 12:30-13:00 lunch buffet 13:00-15:30 Regulatory barriers e.g. re:new adjuvants Norman Baylor (FDA), Pieter Neels (Federal Agency for Medicinal and Round table debate Health Products Brussels & CHMP-EMEA) – Thomas Verstraeten, GSKBio and Michael Decker (Sanofi Aventis,) 15:30-15:50 Break Special lectures: New vaccines in development (1) 15:50-16:20 The challenge of developing new tuberculosis vaccines Paul-Henri Lambert, Geneva 16:20-16:40 Discussion 4 12.01.2010 FRIDAY 22 MAY 2009 SESSION 6 – VACCINE SAFETY - ASSESSMENT OF ADVERSE EFFECTS Chairpersons: Noni Mc Donald and Neal Halsey 09:00-09:30 Lessons from previous adverse effects of vaccination and Assessment of Neal Halsey, Johns Hopkins B. School of Public Health, Baltimore causal relationships 09:30-09:50 Discussion 09:50-10:20 Immunological safety of vaccination (Autoimmune and allergic diseases) Paul-Henri Lambert, 10:20-10:40 Discussion 10:40-11:00 Break 11:00-11:30 Population-based post-licensure surveillance Steve Black Chicago 11:30-11:50 Discussion 11:50-12:20 Immunization safety in developing country vaccination programs Philippe Duclos , WHO 12:20-12:40 Discussion 12:40-13:45 Lunch 13:45-14:15 RISK COMMUNICATION Noni McDonald, Dalhousie Univ, Halifax Canada An overview 14:15-14:35 Discussion Special lectures: New vaccines in development (2) 14:40-15:10 New approaches to vaccine development and delivery Carole Heilman (NIAID) 15:10-15:30 Discussion 15:30-15:50 Break 15:50-16:20 HIV Brigitte Autran , INSERM, France 16:20-16:40 Discussion 16:40-17:10 The challenge of malaria vaccines- Vasee Moorthy , WHO 17:10-17:30 Discussion 17:30-18:00 Info on main ADVAC sponsors activities (1) Ripley Ballou The involvement of the Gates Foudation in Vaccinology Infectious Diseases Programme, Gates Foundation, Seattle 18:00-18:30 Discussion 5 12.01.2010 SATURDAY 23 MAY 2009 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 Coordinated by Catherine Slack who seroconvert during the conduct of an HIV vaccine trial talk with her And Betty Dodet (Lyon) Group 1:- Facilitator: Souleymanne Mboup, Dakar, Senegal Group 2: - Facilitator: Catherine Slack Group 3: - Facilitator: Noni McDonald Group 4: - Facilitator: Betty Dodet Group 5: - Facilitator: TBA Group 6: - Facilitator: Kim Mulholland 6 12.01.2010 MONDAY 25 MAY 2009 SESSION 8.1- INTRODUCING NEW VACCINES INTO VACCINATION Chairperson: Jacob John PROGRAMMES Approaches to help the decision-making process 09:00-09:30 Integration of Science, Public Health and Economics - Critical Assessment of Mark Miller, Fogarty International Center Vaccine Policy Options 09:30-09:45 Discussion 09:45-10:15 Role of disease burden assessment in the decision-making process Brad Gessner AMP 10:15-10:35 Discussion 10:35-11:00 Break 11:00-11:30 Challenge of making evidence-based vaccination policies in developing Jacob John Vellore countries 11:30-11:50 Discussion 11:50-12:20 Access to vaccines : economic aspects, GAVI and AMC Nina Schwalbe , GAVI 12:20-12:40 Discussion 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 12.01.2010 TUESDAY 26 MAY 2009 SESSION 8.2 - INTRODUCING NEW VACCINES INTO VACCINATION Chairperson: Alan Shaw (Vaxinnate) and Bernard Fritzell (Wyeth) PROGRAMMES (2) 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 vaccination strategies: children, adults and elderly Kathy Neuzil, PATH, Seattle 11:00-11:20 Discussion 11:20-11:50 Development of new influenza vaccines Linda Lambert (NIH), 11:50-12:10 Discussion 12:15-13:30 Lunch 13:30-14:00 Vaccines for pandemic response: a global vision Marie-Paule