Teaching department: Epidemiology and Public Health. Pasteur/CNAM School of Public Health

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1 Teaching department: Epidemiology and Public Health Pasteur/CNAM School of Public Health

2 PROGRAM OF THE VACCINOLOGY COURSE (3 rd - 28 th March, 2014) Directors of the course Armelle PHALIPON Molecular Microbial Pathogenesis Unit, INSERM U786, Institut Pasteur Frédéric TANGY Viral Genomics and Vaccination Unit CNRS UMR-3569 Institut Pasteur Head of the Teaching department Epidemiology and Public Heath Arnaud FONTANET Emerging Disease Epidemiology Unit Institut Pasteur The Institut Pasteur and the organizers warmly thank Sanofi Pasteur for its generous contribution to the Vaccinology course by sponsoring fellowships. We are also grateful to the following sponsors for fellowships: E-learning and workshops are made in collaboration with HSeT Foundation.

3 SUMMARY This course offers an integrated overview of Vaccinology by covering all the key issues of vaccine development from design to delivery to the populations in industrialized and developing countries. The course aims at providing the attendees with the knowledge required to become future actors of the international vaccine community. In addition, the world-wide network built-up by the participants over the years helps the emergence of regional/international collaborations. The course encompasses 4 modules: (i) introduction to Vaccinology an integrative discipline, (ii) basic principles of preclinical and clinical steps, (iii) vaccines developed against major infectious diseases, (iv) future challenges. Besides about 60 lectures within these 4 modules, time for discussion with the lecturers on a daily-basis and two e-learning-based workshops on epidemiology modeling and design of a vaccine (this year, bacillary dysentery) are key points in the training of the participants.

4 Module I : Introduction to Vaccinology, an integrative discipline Monday March 3 14:00-16:00 Introduction to the course A. PHALIPON, F. TANGY and Institut Pasteur registration office 16:30-18:00 Short presentations of students Tuesday, March 4 9:00-10:30 The legacy of smallpox eradication: immunization D. TARANTOLA strategies to control, eliminate or eradicate (Univ. New South Wales, Australia) vaccine-preventable diseases 11:00-12:30 The Pasteurian contribution to the history M. SCHWARTZ of vaccines (Institut Pasteur, ) 12:30-14:00 : Lunch 14:00-18:00 Presentation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design Wednesday, March 5 9:00-10:30 Epidemiology of infectious diseases: E. MILLER prerequisite for decision-making in (Public Health England, UK) vaccine development 11:00-13:00 Theoretical biology and mathematical P. WHITE modelling in disease epidemiology (Imperial College, UK) 13:00-14:30 Lunch 14:30-15:30 Sharing experience session: Towards more mathematical modelling in vaccinology? (E. Miller, P. White, A. Phalipon and F. Tangy) 16:00-18:00 Preparation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design Thursday, March 6 9:00-10:30 What a vaccinologist should know about the basic C. LECLERC aspects of immune responses (Institut Pasteur, )

5 11:00-13:00 Immunological memory: the challenge A. LANZAVECCHIA of conferring long-term protection? 13:00-14:30 Lunch (Institute for Research in Biomedicine, Switzerland) 14:30-16:00 Mucosal immunity: advantages and limitations N. LYCKE in developing mucosal vaccines (Institute of Biomedicine, Sweden) 16:00-16:30 Coffee break 16:30-17:30 Sharing experience session: What is still missing in our current knowledge of protective immunity to improve vaccine effectiveness? (C. Leclerc, A. Lanzavecchia, A. Phalipon and F. Tangy) Friday, March 7 9:00-10:30 Vaccination in pregnant women F. MUNOZ (Baylor College of Medicine, USA) 11:00-12:30 Hurdles to vaccination in early life: A. MARCHANT revisiting immunological immaturity (Univ. Libre de Bruxelles, Belgium) in human newborns 12:30-14:00 Lunch 14:00-15:30 Novel strategies for delivering vaccines B. COMBADIERE (Univ. P&M Curie, ) 16:00-17:00 Sharing experience session: What is the future for mother versus newborn vaccination and for the routes of administration? (F. Munoz, A. Marchant, B. Combadière, A. Phalipon and F. Tangy) Monday, March 10 9:00-10:30 Adjuvants: past and future directions G. DEL GIUDICE (Novartis, Italy) 11: Antigen discovery: from genomics to proteomics G. GRANDI (Novartis, Italy) 14:00-15:00 Sharing experience session: How to choose the appropriate strategy? (G. del Giudice, G. Grandi, A. Phalipon and F. Tangy) 15:00-18:00 Preparation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design

6 Module II : Preclinical and clinical steps: basic principles Tuesday, March 11 9:00-10:30 GMP production: which prerequisites and S. BROWN how to proceed (BE Vaccines SAS, ) 11: Preclinical safety testing of vaccines R. FORSTER (CitoxLab, ) 12:30-14:00 Lunch 14:00-16:00 Measurement of immune responses M.- L. GOUGEON during vaccine trials (Institut Pasteur, ) 16:00-16:30 Coffee break 16:30-18:00 Correlates of vaccine-induced immunity - S. PLOTKIN Current problems in vaccine development and possible solutions (Sanofi Pasteur, USA) Wednesday, March 12 9: Phase I/II vaccine trials: methodology D. LEWIS and implementation (University of Surrey, UK) 11:00-12:30 Post license Clinical Trials and pharmacovigilance D. DELATTRE through a practical example (Sanofi Pasteur MSD, ) 12:30-14:00 Lunch 14:00-18:00 Preparation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design

7 Module III : Update of vaccine development for the major infectious diseases Thursday, March 13 The example of new vaccines made recently available 9: The success of the glycoconjugate vaccines M. BEURRET (Crucell, The Netherlands) 11:00-12:30 HPV: a vaccine against virus-induced cancer M.-T. MARTIN (GSK Biologicals, Belgium) 12:30-14:00 Lunch 14:00-17:00 Preparation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design Friday, March 14 Acute respiratory infections 9:00-10:30 Influenza viruses S. MUNIER (Institut Pasteur, ) 11:00-12:30 Influenza vaccines: the challenge to make a new O. ENGELHARDT vaccine each year, vaccines for pandemic flu, (NIBSC, UK) towards a universal vaccine 12:30-14:00 Lunch 14:00-15:30 Challenges for development of vaccines against R. KARRON respiratory diseases: the example of RSV (Johns Hopkins University, USA) 15:30-16:00 Coffee break 16:00-17:30 Sharing experience session: The development of vaccines against pathogens evolving antigen drifting (S. Munier, O. Engelhardt, R. Karron, A. Phalipon and F. Tangy) Monday, March 17 Major poverty-associated infectious diseases 9:00-10:30 Tuberculosis: epidemiology and physiopathology N. WINTER of infection (INRA, ) 11:00-12:30 Immune responses to tuberculosis and S. STENGER vaccine approaches (IMMH, Germany)

8 12:30-14:00 Lunch 14:00-15:30 BCG vaccination in European and African H. DOCKRELL populations: implications for the design of new (LSHTM, UK) tuberculosis vaccines 15:30-16:00 Coffee break 16:00-17:30 Sharing experience session: Will it be possible to do better than BCG against a pathogen so well adapted to its host? (N. Winter, S. Stenger, H. Dockrell, A. Phalipon and F. Tangy Tuesday, March 18 8:30-10:30 Arboviruses: complexity, emergence, V. DEUBEL prevention (Institut Pasteur of Cambodia) 11:00-13:00 Malaria: J. VEKEMANS 1) epidemiology and physiopathology of infection (GSK Biologicals, Belgium) 2) progress and obstacles in the development of a malaria vaccine 13:00-14:30 Lunch 14:30-16:30 Neglected diseases - P. HOTEZ Anthelminthic vaccines: dream or reality? (Baylor College of Medicine, USA) 16:30-17:00 Coffee break 17:00-18:00 Sharing experience session: The particular features of parasites to modulate host immune responses and the impact on vaccine development (V. Deubel, J. Vekemans, P. Hotez, A. Phalipon and F. Tangy) Wednesday, March 19 9:00-11:30 HIV-AIDS: epidemiology and physiopathology G.SILVESTRI (Emory University, USA) 11:30-13:30 Lunch 13:30-15:00 Towards an AIDS vaccine B. AUTRAN (Hôpital Pitié-Salpêtrière, ) 15:00-15:30 Coffee break 15:30-17:00 Phase III vaccine trials: methodology A. PODDA and implementation (Novartis, Italy) 17:00-18:00 Preparation of the workshop A. PHALIPON and F. TANGY Shigella vaccine design

9 Thursday, March 20 9:00-12:30 Workshop Design of a vaccine against shigellosis A. PHALIPON F. TANGY, M.-L. GOUGEON, L. MULARD, Ph. SANSONETTI, C. GERKE and D. COHEN 12:30-14:00 Lunch 14:00-17:00 Workshop (continuation) Friday, March 21 9:00-10:30 Shigella vaccine: what will be the next step? Ph. SANSONETTI (Institut Pasteur, ) 11:00-12:30 The issue of vaccination against cholera C. L. CHAIGNAT (WHO, Switzerland) 12:30-14:00 Lunch 14:00-15:30 Rotavirus vaccines: success and drawback T. VESIKARI in developed and developing countries (Univ. of Tampere, Finland) 15:30-16:00 Coffee break 16:00-17:30 Sharing experience session: Preventing diarrheal disease, a complex issue? (Ph. Sansonetti, T. Vesikari, C.L. Chaignat, A. Phalipon and F. Tangy)

10 Module IV : Future challenges Monday, March 24 9:00-10:30 What are the issues vaccine manufacturers R. RAPPUOLI take into account for go/no go in developing (Novartis, Italy) a new vaccine 11:00-12:30 Finding correlates of protection or the holy grail L. JODAR to avoid large phase III clinical trials (Pfizer, USA) 12:30-14:00 Lunch 14:00-15:30 Anti-cancer vaccines: dream or reality? C. LECLERC (Institut Pasteur, ) 15:30-16:00 Coffee break 16:00-17:30 Aging population and vaccination B. WEINBERGER (University of Innsbruck, Austria) Tuesday, March 25 9:00-10:30 Globalization of vaccine production J. CALMET (Sanofi Pasteur, ) 11:00-12:30 The long and winding road to make vaccines D. CHANG BLANC accessible to the population in need: (WHO, Switzerland) an infrastructure issue 12:30-14:00 Lunch 14:00-15:30 The long and winding road to make vaccine accessible D. ATHERLY to the population in need: an economical issue (PATH, USA) 15:30-16:00 Coffee break 16:00-17:30 Sharing experience session: How to improve vaccine implementation on the field? (J. Calmet, D. Atherly, A. Phalipon and F. Tangy) Wednesday, March 26 9:00-10:30 Of the importance of following epidemiology N. GUISO upon vaccination: the example of pertussis (Institut Pasteur, ) and diphtheria vaccines

11 11:00-12:30 Of the importance of maintaining vaccine D. LEVY-BRUHL coverage: the example of measles (InVS, ) 12:30-14:00 Lunch 14:00-17:30 Free to prepare the exam Thursday, March 27 11:00-12:00 Written examination: Multiple choice question paper Duration: one hour 12:00-14:00 Lunch 14:00-15:30 Perception of vaccination A. THOMSON (Sanofi Pasteur, ) 16:00-17:00 Visit of the Institut Pasteur Museum Friday, March 28 9:00-10:00 Feedback exam A. PHALIPON and F. TANGY 10:00-11:00 Visit of laboratories 12:00-14:30 Closing party

12 VACCINOLOGY COURSE DIRECTORS Ms PHALIPON Armelle Unité Pathogénie Microbienne Moléculaire Institut Pasteur 25/28 rue du Dr Roux Paris Cedex 15 () Tel +33-(0) Mr TANGY Frédéric Unité Génomique virale et Vaccination Institut Pasteur 25/28 rue du Dr Roux Paris Cedex 15 () Tel +33-(0)

13 LECTURERS Ms ATHERLY Deborah Senior Health Economist and Policy Officer PATH P.O.Box Seattle, WA USA Ms AUTRAN Brigitte Pôle Biologie Médicale & Pathologie, Département d'immunologie, Hôpital Pitié-Salpêtrière +33-(0) , boulevard de l'hôpital Paris Cedex 13 Mr BEURRET Michel Sr. Director Bacterial Conjugates and Process Integration Crucell Holland B.V P.O.Box CA Leiden The Netherlands Mr BROWN Stephen CTO BE Vaccines SAS +33-(0) , rue Alain Bombard Saint-Herblain Mr CALMET Joël Sanofi Pasteur +33-(0) , avenue Pont Pasteur Lyon Cedex 07 Ms CHAIGNAT Claire-Lise Global Task Force on Cholera Control, HSE / PHE WHO Via Appia 20 chaignatc@who.int 1211 Geneva 27 Switzerland

14 Ms CHANG BLANC Diana Dept of Immunization, Vaccines & Biologicals, World Health Organization Avenue Appia Geneve 27 Switzerland Mr COHEN Daniel I. School of Public Health Sackler Faculty of Medicine Tel Aviv University Ramat Aviv Tel Aviv Israel Ms COMBADIERE Béhazine INSERM U945 UPMC Paris 6 Laboratory of Immunity +33-(0) , boulevard de l'hôpital behazine.combadiere@upmc.fr Paris Mr DEL GIUDICE Giuseppe Global Head Translational Medicine Novartis Vaccines & Diagnostics Research Center Via Fiorentina 1 giuseppe.del_giudice@novartis.com Siena Italy Ms DELATTRE Dominique EU QPPV Senior Director, PVRM Sanofi Pasteur MSD +33-(0) , rue Jonas Salk Ddelattre@spmsd.com Lyon Cedex 07 Mr DEUBEL Vincent Director Institut Pasteur du Cambodge +855-(0) Bld Monivong vdeubel@pasteur-kh.org Phnom Penh Kingdom of Cambodia

15 Ms DOCKRELL Hazel Immunology Unit Dept. Infectious & Tropical Diseases London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT UK Mr ENGELHARDT Othmar G. Principal Scientist, Division of Virology National Institute for Biological Standards and Control (NIBSC) Blanche Lane, South Mimms Potters Bar, Hertfordshire, EN6 3QG UK Mr FORSTER Roy CitoxLAB +33-(0) BP Evreux Cedex Ms GERKE Christiane Novartis Institutes for Biomedical Research Novartis Vaccines Institute for Global Health, S.r.l Via Fiorentina 1 christiane.gerke@novartis.com Siena Italy Ms GOUGEON Marie-Lise Antiviral Immunity, Biotherapy and Vaccine Unit, Institut Pasteur +33-(0) /28, rue du Dr Roux marie-lise.gougeon@pasteur.fr Paris Cedex 15 Mr GRANDI Guido Novartis Vaccines Via Fiorentina 1 guido.grandi@novartis.com Siena Italy Ms GUISO Nicole Unité Prévention & Thérapie Moléculaire des Maladies Humaines Institut Pasteur +33-(0) /28, rue du Dr Roux nicole.guiso@pasteur.fr Paris Cedex 15

16 Mr HOTEZ Peter National School of Tropical Medicine Baylor College of Medicine 1 Baylor Plaza hotez@bcm.edu Houston, TX USA Mr JODAR Luis Head Vaccines Medical Affairs EM (Africa/Middle East, Asia Pacific, Eastern Europe & Latin America Pfizer Inc East 42nd Street Luis.Jodar@pfizer.com New-York, NY USA Ms KARRON Ruth A. Director, Center for Immunization Research Director, Johns Hopkins Vaccine Initiative Bloomberg School of Public Health Johns Hopkins University rkarron@jhsph.edu Baltimore, MD USA Mr LANZAVECCHIA Antonio Director, Institute for Research in Biomedicine Via Vincenzo Vela 6 lanzavecchia@irb.usi.ch 6500 Bellinzona Switzerland Ms LECLERC Claude Unité Régulation Immunitaire et Vaccinologie Institut Pasteur +33-(0) /28, rue du Dr Roux claude.leclerc@pasteur.fr Paris Cedex 15 Mr LEVY-BRUHL Daniel Département des Maladies Infectieuses Institut de Veille Sanitaire +33(0) , rue du Val d'osne d.levybruhl@invs.sante.fr Saint-Maurice Cedex

17 Mr LEWIS David Professor of Clinical Vaccine Immunology Clinical Research Centre University of Surrey Egerton Road Guildford, Surrey GU2 7XP UK Mr LYCKE Nils Mucosal Immunobiology & Vaccine Center (MIVAC) Depart. Microbiology & Immunology Institute of Biomedicine Box Gothenburg Sweden Mr MARCHANT Arnaud Institut d'immunologie Médicale Université Libre de Bruxelles Rue Adrienne Bolland 8 armarcha@ulb.ac.be 6041 Charleroi Belgium Ms MARTIN Marie-Thérèse Vice-President Division Vaccine Discovery and Development GSK Biologicals 20 Avenue Flemming marie-therese.martin@gskbio.com 1300 Wavre Belgium Ms MILLER Elizabeth Immunisation, Hepatitis & Blood Safety Department Public Health England Colindale Avenue Liz.Miller@phe.gov.uk London NW9 5EQ UK Ms MULARD Laurence Unité de Chimie des Biomolécules Institut Pasteur +33-(0) /28, rue du Dr Roux laurence.mulard@pasteur.fr Paris Cedex 15

18 Ms MUNIER Sandie Unité de Génétique Moléculaire des Virus à ARN Institut Pasteur +33-(0) /28, rue du Dr Roux Paris Cedex 15 Ms MUNOZ-RIVAS Flor Section of Infectious Diseases Molecular Virology and Microbiology Baylor College of Medicine Houston, TX USA Mr PLOTKIN Stanley Emeritus Professor of Pediatrics University of Pensylvania Vaxconsult USA Mr PODDA Audino Head, Clinical Development & Regulatory Affairs Novartis Vaccines Institute for Global Health (NVGH) Via Fiorentina 1 audino.podda@novartis.com Siena Italy Mr RAPPUOLI Rino Novartis Vaccines & Diagnostics Srl, Global Research Via Fiorentina 1 rino.rappuoli@novartis.com Siena Italy Mr SANSONETTI Philippe Unité Pathogénie Microbienne Moléculaire Institut Pasteur +33-(0) /28, rue du Dr Roux philippe.sansonetti@pasteur.fr Paris Cedex 15 Mr SCHWARTZ Maxime Institut Pasteur 25/28, rue du Dr Roux maxime.schwartz@pasteur.fr Paris Cedex 15

19 Mr SILVESTRI Guido Emory University School of Medicine Chief, Division of Microbiology & Immunology Yerkes National Primate Research Center Gatewood Road NE Atlanta, GA USA Mr STENGER Steffen Universitätsklinikum Ulm Institut für Med. Mikrobiologie und Hygiene Albert-Einstein-Allee 11 (M23/4204) Ulm Germany Mr TARANTOLA Daniel Visiting Professorial Fellow University of New South Wales, Australia (residential address in ) daniel.tarantola@gmail.com Mr THOMSON Angus Director, Global Immunisation Policy Sanofi Pasteur +33-(0) , avenue Pont Pasteur Angus.Thomson@sanofipasteur.com Lyon Cedex 07 Mr VEKEMANS Johan Director, Global Clinical Research & Development GSK Biologicals Parc de la Noire Epine, Av. Fleming 20 johan.vekemans@gskbio.com 1300 Wavre Belgium Mr VESIKARI Timo University of Tampere Medical School Vaccine Research Center Biokatu 10 (FM3 Building) timo.vesikari@uta.fi Tampere Finland Ms WEINBERGER Birgit Institute for Biomedical Aging Research University of Innsbruck Rennweg 10 Birgit.Weinberger@uibk.ac.at 6020 Innsbruck Austria

20 Mr WHITE Peter Department of Infectious Disease Epidemiology Imperial College Faculty of Medicine Norfolk Place London, W2 1PG UK Ms WINTER Nathalie UMR INRA-Université de Tours Infectiologie & Santé Publique +33-(0) Centre INRA de Tours, Bât Nouzilly

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