Tomorrow's vaccines today

Transcription

1 Tomorrow's vaccines today Dr Odile Leroy Dublin, ESOF, 14th July

2 My background 1927: TetanusVaccine (Ramon and Descombey) Opisthotonos Sir Charles Bell, s: ~ 1M Neonatal Tetanus death/year Neonatal Tetanus, CDC. 2008: NT deaths 92% reduction 2

3 Maternal and Neonatal Tetanus Elimination by 2012 Yes, We Can! Global Immuniza4on Mee4ng 18 th February

4 China : 10th century China 1. Scabs from mildly affected smallpox pa4ents 2. Ground up (4:1) with Uvularia grandiflora 3. stored 1 month, and 4. inoculated intranasally 6 days arer: fever 9-10 days arer rash «not one in 10, not one in 100 does not recover» 3 I paradigm 4

5 Number of Countries with more than one case per month years after Jenner : WHO declares the eradication of small pox Ø Vaccines are powerful public health tool 5

6 Malaria Eradication (1960) (2011) malera - a research agenda for malaria eradication. PLoS Collections 7(13): ev07.i13. 6

7 Long history of parasitism 7

8 Vaccine development challenges Heuristic, empirical approach All easy vaccines have been developed Isolate-Inactivate-Inject paradigm is ineffective for hyper-variable pathogens Malaria, shistosomiasis, HIV, RSV, chlamydia, herpes.. 8

9 Vaccine development challenges Limits of empirical approach: Infection not controlled by neutralizing antibodies Immunity from disease prevent pathology but not spread Immaturity of immune system at time of exposure (RSV) Maternal Antibody transfer interferes with vaccine response (RSV, measles) Genetic variability of pathogen / antigens Natural disease does not provide immunity (HIV, herpes..) Natural Immunity results from repeated infection (malaria) 9

10 Vaccine development challenges Inter-individual variation Dosing Immunogenicity Safety Vaccinomics 10

11 Nohynek H, Jokinen J, Partinen M, Vaarala O, Kirjavainen T, Sundman J, Himanen SL, Hublin C, Julkunen I, Olsén P, Saarenpää-Heikkilä O, Kilpi T. AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS One. 2012;7(3):e HLA- DQB1*0602 genotype Age distribu5on of the new narcolep5c cases among the Pandemrix vaccinated and unvaccinated children and adolescents. Personnalised vaccinology N 6 4 vaccinated non vaccinated

12 How to address those challenges in Europe? The role of TRANSVAC European Network of Vaccine Research & Development 12

13 European vaccine R&D (still) strong 13

14 The Public Vaccine Institutions in Europe Now Private Up to 90s Still Public NFIA Serum Ins4tute of #India #SII buys produc4on facili4es of state- owned #Netherlands Vaccine Ins4tute #NVI h]p://bit.ly/lutete #nfia_news 10:58 PM - 2 Juill, 12 via web 14

15 What is needed? To foster European Efforts for a global impact To maintain and strengthen European Infrastructure : European leadership in vaccine R&D as driver force 15

16 TRANSVAC Partners Grenoble, FR Ins4tuto de Biologia Experimental e Tecnológica, PT 16

17 A clear example of Integrating Activity Service-oriented programme To provide trans-national access to researchers or research teams : Delivery of services Adjuvant : vaccine formulation Vaccine pre-clinical animal model Global analyses (ILLUMINA Deep Sequencing, AGILENT Microarrays, AFFYMETRIX Microarrays) Stable assay and reference reagent standards platform GMP cell line bank for viral vector vaccine production 17

18 A clear example of Integrating Activity Service-oriented programme To improve the services provided by the infrastructures (in quality and/or quantity) Roadmap for improved services developing trans-diseases research programmes Immuno-assays for pre-clinical assessment or quality control assessment, or Analysis or physical-chemical characteristics of antigen/adjuvant formulations, in a regulatory perspective, Proteomic/transcriptomic analysis of clinical trial samples 18

19 A clear example of Integrating Activity Service-oriented programme To foster a culture of cooperation between the research infrastructures and the related scientific communities Interlab interactions to qualify / validate reference reagents Harmonisation of immunoassay systems; clinical trials analysis Laboratory communication, data sharing, modular course on vaccine development 19

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21 The Goal The end of them and us Meredith Wadman NATURE

22 Acknowledgements EVI donors DGIS Irish Aid German BMBF EC FP6/FP7 EVI EEIG members Stockholm University, SE Heidelberg University, DE Royal College of Surgeon in Ireland, IE Jenner Vaccine Foundation-University of Oxford, UK Biomedical Primate Research Centre NL National Institute for Public Health and the Environment, NL Scientific Community Europe Africa India Volunteers in EVI funded clinical trials EVI sub-contractors, CMOs, CROs, Consultants 22