Ebola - retour d expérience sur la mise en place d essais vaccinaux

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1 De fis Scientifiques et Economiques du De veloppement de Vaccins pour les Pays du Sud 2 & 3 Décembre 2015, Institut Pasteur, Paris Ebola - retour d expérience sur la mise en place d essais vaccinaux Pr Rodolphe Thiébaut Copyright 2015 Ebovac2 I 1

2 The context Urgent development of Ebola vaccine needed IMI2 call 2 Ebola + program Copyright 2015 Ebovac2 I 2

3 The context Copyright 2015 Ebovac2 I 3

4 The EBOVAC Program The overall aim of the EBOVAC programme is to assess the safety, immunogenicity and efficacy of a Ad26/MVA vaccine regimen against EVD EBOVAC1 covers the Phase 1 and Phase 3, whereas EBOVAC2 Phase 2 trials Copyright 2015 Ebovac2 I 4

5 EBOVAC2 partners Participant No Participant organisation name Country 1 (Coordinator) 2 (Project Leader) Institut National de la Santé et de la Recherche Médicale (INSERM) Crucell Holland B.V (Janssen) London School of Hygiene and Tropical Medicine (LSHTM) The Chancellor, Masters and Scholars of the University of Oxford (UOXF) Le Centre MURAZ (Muraz) Inserm Transfert (IT) France The Netherlands United Kingdom United Kingdom Burkina Faso France African partner involved from the beginning Copyright 2015 Ebovac2 I 5

6 EBOVAC2 Workpackages WP 1 Coordination and Management (INSERM) R. Thiebaut WP 2 Clinical Core (INSERM/Janssen) WP 3 Immune monitoring (Inserm/Janssen) L. Richert/M.Douoguih C. Lacabaratz/K. Luhn WP 4 NHP (INSERM) H. Raoul WP5 Data Management & integration (Janssen) A. Rowe WP6 Communication Capacity building (IT) S. Quigley Going beyond a clinical trial (capacity building, training, social sciences research, systems vaccinology) Copyright 2015 Ebovac2 I 6

7 EBOVAC2 Trial Management INDEPENDENT DATA MONITORING COMMITTEE EBOVAC CLINICAL STEERING COMMITTEE WP3 Immune monitoring (Inserm and Janssen) WP2 TRIAL MANAGEMENT TEAM Coordinating Clinical Trials Unit (Inserm, Bordeaux) Faciliation and liaising for: Protocol development (for Inserm partners) Global progress reports, risk management & performance indicators Harmonized communication Site budget SPONSOR (Janssen) Protocol writing Regulatory Pharmacovigilance Vaccine manufacturing and supply Data management Monitoring Statistical analyses of core trial data Built on existing experience of Janssen and F-CRIN / INSERM Copyright 2015 Ebovac2 I 7

8 Phase 2 Clinical Trials Africa N=1188 0,84 0,56 0,28 (Adults only) Healthy adults + HIV, Kids 1-17 Europe N=612 0,84 0,56 0,28 Healthy adults + Immunological substudies Built on existing networks: ANRS sites, VRI, i-reivac, Janssen Copyright 2015 Ebovac2 I 8

9 People Anton Ottavi (EC project coordinator) Christine Schwimmer (EC project coordinator) Laura Richert (WP2 co-leader) Christine Betard (Clinical trials coordinator) Laetitia Moinot (Clinical trials coordinator) Eugénie Destandau (Communication) Sandrine Darmigny (Assistant) Need for coordination weekly meetings with sites, project leader/coordinator Need for communication letter, newletter, investigator meeting Copyright 2015 Ebovac2 I 9

10 People Investigator meeting Site meeting Copyright 2015 Ebovac2 I 10

11 Regulatory affairs African Vaccine Regulatory Forum (AVAREF) Organized by WHO 3 days meeting (9-11 June, Accra) with regulatory authorities and EC from each country Final timelines: 11 June AVAREF August Cote d Ivoire Uganda November Kenya Burkina Faso Copyright 2015 Ebovac2 I 11

12 Capacity building New building for vaccination Training for PBMC Copyright 2015 Ebovac2 I 12

13 Networking Projet San Francisco, Kigali, Rwanda KIAVI, Nairobi, Kenya Training by Janssen and other teams involved in the project Copyright 2015 Ebovac2 I 13

14 Various recruitment strategies PACCI, Abidjan, Côte d Ivoire CNTS: Centre National de Transfusion Sanguine Toupah: site communautaire Copyright 2015 Ebovac2 I 14

15 Conclusions A lot of usual aspects of implementation of phase 2 RCT Reactivity associated to existing networks Some specificities Emergency IMI2 context Opportunity for capacity building and further vaccine development Copyright 2015 Ebovac2 I 15

16 16 Copyright 2015 Ebovac2 I 16 16

17 Study design Copyright 2015 Ebovac2 I 17

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