«I-Reivac» Un réseau d excellence pour la recherche clinique en vaccinologie

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1 «I-Reivac» Un réseau d excellence pour la recherche clinique en vaccinologie I-Reivac Pr Odile Launay Inserm, Université Paris Descartes, AP-HP, Hôpital Cochin, Paris F-CRIN, une infrastructure pour l excellence de la recherche clinique Paris, 18 Mars 2014

2 Introduction Le développement de la recherche en vaccinologie : enjeu majeur en terme de Santé Publique pour la France Nécessité d améliorer les connaissances : - par le renforcement de la recherche clinique et des recherches en sciences humaines et sociales, - par une meilleure formation des soignants et de la population, pour permettre de rétablir la confiance et augmenter la couverture vaccinale

3 REIVAC History : 4 CIC founders (COPIL) 1 CIC BT-Vaccinology (Cochin, Paris) and 3 CIC Multi-topic (Bichat, Paris, Mtpellier, Clermont Ferrand) : 14 associate members - 1 CIC EC-Vaccinology (St Etienne), - 5 CICs Multi-topic (Rennes, Limoges, Lille, Strasbourg, Nancy) - 1 CIC BT Nephrology (Besancon) - 1 Clinical research unit of Immunology (Lyon) - 2 CRCs Infectious diseases (Lyon, Annecy) - 3 Infectious diseases departments- geriatric (St Louis, Paris, Nancy, Nimes) - 1 Epidemiology and Prevention department (Lyon) Founders Rennes Additional members Limoges Bichat Cochin Lille Saint- Louis Clermont- Ferrand Saint- Etienne Montpellier Dijon Lyon Nimes Nancy Besançon Strasbourg Annecy Two laboratories of Immunology located in Cochin and Saint-Etienne Hospitals

4 REIVAC experience REIVAC Studies 25 industrial studies (18 International, 6 European, 1 National) 11 academic studies (2 International, 1 European, 8 National) 16 preventive vaccines (1461 participants) 9 therapeutics vaccines (115 included patients) 11 clinical studies (1448 participants) Including. 6 with industrial partnership

5 specific objectives 1. To reinforce visibility and competitiveness of France in the field of vaccinology 2. To boost the French excellence in clinical research dedicated to vaccinology : - from early clinical trials, in connection with the pharmaceutical industry - to large international academic clinical trials coordinated by French scientists - including observational studies 3. To develop strong and efficient collaborations at European and International levels in vaccinology 4. To implement an attractive scientific program

6 Six core activities 1. Clinical development of new anti-infective vaccines (preventive and therapeutic), focusing on early phase studies in collaboration with public and private partners. 2. Vaccination of special populations promoting the development of international collaborations for studies in patients with rare and/or complex diseases [diabetes, auto immunity transplantation, pregnancy, elderly and healthcare workers) 3. Clarification of the risk / benefit of vaccination with the implementation of Phase 4 studies of pharmacoepidemiology and vaccine effectiveness in populations. 4. Evaluation of immunological mechanisms and determinants of response to vaccination including the identification of biomarkers and correlates of protection. 5. Human and Social Sciences dimension in vaccination: introduction of specific studies or studies nested in order to better identify the determinants of acceptance or refusal of vaccination ans implementation of interventions. 6. Biobank tools Clinical development of new preventive and therapeutic anti-effective vaccines Human and Social Sciences Vaccinations of special populations I-REIVAC Biobank and tools and procedures Pharmacoepidemiology and vaccine efficacy in population Immunological mechanisms and determinants of response to vaccination

7 Seven Work Packages Odile Launay Pierre Verger Odile Launay Pierre Loulergue Philippe Vanhems Jean-Louis Koeck Béhazine Combadière Christian Dualé Odile Launay

8 Strategic Plan E-CRIN ITMOSP / ITMOIMMI (COREVAC) F-CRIN Coordinator Coordination team WP Leaders Academics Partners N=33 Industrials - Associated members (n=16)

9 Operational part

10 Operational part

11 Training and Dissemination Training in partnership with F-CRIN - Training of young physicians in clinical research - Training in vaccinology: the European Master Erasmus - Training for principal investigators - Training for CEC, ERC, TEC, ARC Dissemination in partnership with F-CRIN - Quarterly internal newsletter and annual leaflet for external communication - Website animation - Annual scientific dissemination days, - Joint meetings with COREVAC - Regular participation to national and international congresses on vaccinology and related domains (infectious diseases, microbiology, epidemiology, public health, etc.) - Reflection on using appropriate tools for sharing information with media and general population

12 Strengths I-REIVAC proposes A well structured, recognized and experienced network of physicians, clinicians, scientists, nurses with complementary expertises A well organized Coordination team and experienced coordinator to set up and manage multiple collaborations from national to international levels An ambitious scientific program that will respond to industrial requirements as well as scientific excellence A platform of required expertises in clinical trials including regulatory, ethics, operational activities, management, monitoring expertises with internationally well-known WP leaders Network of immuno-monitoring platforms Cohort of patients and Biobanking Close collaboration with EUCLID platform Strong industrial collaborations To contribute to the social acceptance of vaccination and public dissemination

13 Contacts WP leaders: Odile Launay et Pierre Loulergue: CIC Cochin Pasteur, Paris, Philippe Vanhems, Hospices civiles de Lyon Behazine Combadière, Inserm U495, UPMC, Paris Pierre Verger, ORS-Inserm UMR912, Lyon Jean-Louis Koeck, Hôpital d instruction des armées, Bordeaux Christian Dualé, CIC de Clermont Ferrand Equipe de coordination: Nezha Lenzi, Hôpital Cochin, Paris Nous contacter: odile.launay@cch.aphp.fr; nezha.lenzi@cch.aphp.fr