TENTH ADVANCED COURSE OF VACCINOLOGY- 2009

Transcription

1 TENTH ADVANCED COURSE OF VACCINOLOGY MONDAY 18 MAY :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

2 TUESDAY 19 MAY 2009 SESSION 2 - HOW VACCINES WORK 09:00-09:30 1. How are vaccine responses elicited? What a vaccinologist should know about the basic aspects of immunological responses a- B-cell responses Chairpersons: Adam Finn and Paul-Henri Lambert Claire-Anne Siegrist, University of Geneva 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

3 WEDNESDAY 20 MAY 2009 SESSION 3 DECISION-MAKING IN VACCINE RESEARCH AND PRECLINICAL DEVELOPMENT Chairpersons: Luc Hessel & Georges Thiry 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: Overview Stanley Plotkin, University of Pennsylvania, Philadelphia and Sanofi 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

4 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 phase III trial (pneumococcal conjugate vaccine in The Gambia, among Navajo Indians in the U.S. and in South Africa ) Introduction 15 min Introduction to statistical aspects of clinical trials- 2- Statistical assessment of phase 3 trials- 30 min Introduction to the group work 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 Round table debate Objective: To understand how to critically appraise and compare phase III trial results Juhani Eskola & Hanna Nohynek Peter Smith, LSTMH, UK Hanna Nohynek 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 Norman Baylor (FDA), Pieter Neels (Federal Agency for Medicinal and Health Products Brussels & CHMP-EMEA) Thomas Verstraeten, GSKBio and Michael Decker (Sanofi Aventis,) 4

5 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) The involvement of the Gates Foudation in Vaccinology 18:00-18:30 Discussion Ripley Ballou Infectious Diseases Programme, Gates Foundation, Seattle 5

6 SATURDAY 23 MAY 2009 SESSION 7- ETHICAL ISSUES Ethical issues related to clinical trials Revisiting the Helsinki Declaration 08:45-09:20 Clinical trials in developing countries: Ethical issues 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 during the conduct of an HIV vaccine trial talk with her 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 Chairpersons: Betty Dodet and Catherine Slack Catherine Slack (University of KwaZulu-Natal, South Africa) Coordinated by Catherine Slack And Betty Dodet (Lyon) 6

7 MONDAY 25 MAY 2009 SESSION 8.1- INTRODUCING NEW VACCINES INTO VACCINATION PROGRAMMES Approaches to help the decision-making process 09:00-09:30 Integration of Science, Public Health and Economics - Critical Assessment of Chairperson: Jacob John 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 countries Mark Miller, Fogarty International Center Jacob John Vellore 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: The population biology of bacterial pathogens and its importance for vaccination strategies 17:20-17:40 Discussion - Richard Moxon, Oxford University 7

8 TUESDAY 26 MAY 2009 SESSION 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 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 Kieny (WHO) 14:00-14:20 Discussion 14:20-15:20 Vaccination schedules Past, present and future Is there some rationale? 15:20-15:40 Discussion 15:40-16:10 Case-specific study #4 Rotavirus vaccines: Present status and introduction in industrialized and developing countries 16:10-16:30 Discussion 16:30-18:45 Small group exercise 4: Decision-making for the use of new vaccines in selected countries Objective: To learn what facts are needed in a decision-making process and how other factors influence the outcome Group 1: Rota vaccine Umesh Parashar and TBA Group 2: HPV Alan Shaw and Keith Klugman Group 3: HPV Edwin Asturias and TBA Group 4: Rota - Group 5: Pneumococcal conjugate vaccine Bernard Fritzell Group 6: Pneumococcal conjugate vaccine - Hanna Nohynek Neal Halsey & Philippe Duclos, WHO Umesh Parashar (CDC) organized by Hanna Nohynek 8

9 WEDNESDAY 27 MAY 2009 SESSION 9 - SELECTING APPROPRIATE VACCINATION STRATEGIES Chairpersons: Janet Englund and Jacob John 1. Vaccination in the elderly 09:00-09:30 Vaccination and Immuno-senescence Richard Aspinall, Imperial College London 09:30-09:50 Discussion 2. Vaccination in early life 09:50-10:20 Advantages and limitations Claire-Anne Siegrist, University of Geneva 10:20-10:40 Discussion 10:40-11:00 Break 3. Vaccination and pregnancy 11:00-11:30 Main issues and applications in developed and developing countries Janet Englund, Children s Hospital and Regional Medical Center, Seattle 11:30-11:50 Discussion 11:50-14:00 Parallel working group sessions (with sandwich lunch) 1. Identifying Capacity Building needs in Developing Countries Special - Working group setting-up recommendations for EC & other funding agencies 2.National decision making for immunization programmes 3.Clinical vaccinology : patients'problem solving Arnd Hoeveler, EC, Brussels, Charles Mgone (Executive Director EDCTP) and Alan Shaw, Vaxinnate Melinda Wharton, CDC, and Philippe Duclos (WHO) CA Siegrist and Alessandro Diana 14:00-14:30 Varicella and Zoster vaccines: what are the issues? Stanley Plotkin 14:30-14:50 Discussion 14:50-15:20 Info on main ADVAC sponsors activities- Arnd Hoeveler, Head, Health and Biotechnology, EC, Brussels Research perspectives in vaccinology: The EC FP7 programme 15:20-15:40 Discussion 15:40-16:00 Break CELEBRATION OF ADVAC 10 th ANNIVERSARY Chairman: Paul-Henri Lambert 16:00-17:00 Presentations by ADVAC alumni- winners of 10 th anniversary ADVAC awards : Post-ADVAC achievements? (each 10 min presentation + 5 min discussion) Ding-Ping Liu (Taiwan), Luiz Camacho (Brasil), Shabir Madhi (S-Afr), Sonali Kochhar (India), 17:00-17:40 The Plotkin Lecture: The Value of Vaccination 17:40-18:00 discussion 18:00 Departure to Château de Menthon visit and special reception - Celebration of the tenth Anniversary David Bloom, Harvard PHS 9

10 THURSDAY 28 MAY 2009 Special lectures: New vaccines Chairperson: Michel Dewilde (Sanofi-Pasteur) 09:00-09:30 Prospects for dengue and JE vaccines Hal Margolis IVI, Seoul 09:30-09:50 Discussion 09:50-10:20 HPV vaccines John Schiller (NIH) 10:20-10:40 Discussion 10:40-11:00 Break 11:00-11:30 Lessons from HIV trials in developing countries Jean William Pape, Gheskio, Haiti 11:30-11:50 Discussion 11:50-12:20 Vaccination in immune-compromised individuals, Claire-Anne Siegrist, University of Geneva 12:20-12:40 Discussion 12:40-14:00 Lunch including HIV positive patients 14:00-16:00 Eradication strategies : Polio eradication? Optimal strategies? overview and debate 16:00 Presentations by participants and poster discussion Brief presentations by participants and poster discussion Bruce Aylward WHO (30 min) Jacob John, Vellore, India (20 min) Stanley Plotkin, University of Pennsylvania (20 min) 10

11 FRIDAY 29 MAY 2009 SESSION 10: FACING THE MEDIA Chairperson: Edwin Asturias 09:00-12:30 Interactive session Deborah Hall, Broadcaster and media affairs consultant, London, Introduction to media dynamics: How to best deliver vaccinology r elated messages to different interest groups Lunch 14:00-15:00 CME credits Diploma ceremony Distribution of CD Roms with course slides (organized by Edwin Asturias) Stanley Plotkin and Paul Henri Lambert 15:15 Closure of the Course The educational quality of the course will be certified by Prof. Claire- Anne Siegrist and Dr Hanna Nohynek (CME related issues) 11