OS18 - 9.b.1 A GVII-2015, a new high potency vaccine with broad protection against A/ASIA/G-VII threat - H. Gaude
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OS18 - Open Session 2018 Borgo Egnazia (Puglia), Italy 29 - 31 /10/2018 EuFMD Sessions\Open Session\Archive-2018\Open 2018 - Italy\6. Online & Streaming\PPTs
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OS18 - 9.b.1 A GVII-2015, a new high potency vaccine with broad protection against A/ASIA/G-VII threat - H. Gaude
- 1. Hélène GAUDE A GVII-2015, a new high potency vaccine with broad protection against A/Asia/G-VII threat OS18
- 2. • Unexpected FMDV movement from the Indian sub-continent • Emergence of FMDV serotype A lineage A/ASIA/G-VII caused outbreaks in the Middle East. • Reports of outbreaks in vaccinated areas • Added by WRLFMD to the list of priority strains for European banks Epidemiological context FMD free Sporadic A/ASIA/G-VII reported notifications Endemic A/ASIA/G-VII trend of spread Source: http://www.wrlfmd.org/fmd_genotyping/index.html September 2015
- 3. A/SAU/1/2015 A/SAU/2/2015 A-Iran-05 0 0 A-Iran-87 0 0.04 A-Iran-96 0.04 0.06 A-Iran-99 0.01 0.01 A-Sau-95 0.20 0.19 A-22 0.11 0.11 A-Tur-20-06 0.03 0.06 A-May-97 0.14 0.23 Source: The Pirbright Institute - WRLFMD • Immediate / temporary vaccine solution: A Saudi95, commercially available vaccine strain Ø gap in r1 matching Ø partial protection against A/ASIA/G-VII * BI's response to the outbreaks * Source: R. Waters et al. 2018 • A sustainable, fully effective vaccine solution is required è development of a new vaccine strain against A/ASIA/G-VII.
- 4. A/ASIA/G-VII field isolates from WRL and from outbreak countries Vaccine candidate Adaptation to BHK-21 cell culture Selection of best vaccine candidate CRITERIA: Ä Manufacturability : to ensure long term sustainability of the future vaccine strain supply Ä Epidemiological relevance : to allow development of a vaccine strain providing the most adapted match vs circulating strains DRIVERS: Emergency & Compliance Adaptation of field isolates & Selection of vaccine candidate LELYSTAD, NL
- 5. Production Process Scale up & Robustness to ensure capacity to produce sufficient number of doses at acceptable cost Formulation as oily or aqueous vaccine (Double Oil Emulsion or Aluminium hydroxide Saponin) Vaccine candidate A GVII-2015 Master Seed Virus (MSV) Stock A GVII-2015 Antigen A GVII-2015 Vaccines MSV purity controlled according to the Eur. Pharmacopeia Extraneous agent MSV Status Bacteria ü Free Fungi ü Free Mycoplasma ü Free Virus ü Free Industrial scale R&D scale PIRBRIGHT, UK Production process development & Industrialization of the vaccine EU GMP EU GMP EU GMP
- 6. A GVII-2015 Vaccines Safety Immunogenicity Coverage Potency Stability Vaccines clinical evaluation
- 7. D0 D21 AFTOVAXPURTM 0.55 3.55 0.55 3.40 0.55 3.40 0.55 3.25 0.70 3.10 Mean 0.58 3.34 AFTOPORTM 0.55 3.40 0.70 3.25 0.70 3.10 0.55 2.80 0.70 3.25 Mean 0.64 3.16 q Vaccination of 5 cattle at standard dose x 2 vaccines q Virus Neutralization Titer determined 21 dpv Ø Results: High serological response with both formulations Conclusion: Serological potency of A GVII-2015 vaccine is satisfactory A GVII-2015 vaccine immunogenicity 0 1 2 3 4 AFTOVAXPUR AFTOPOR D0 D21 BI pass level Average VN Titers (5 animals) HomologousAbresponse (log10VNTiters)
- 8. Conclusion: Cross-neutralization spectrum indicates a good protection against the A/ASIA/G-VII lineage A GVII-2015 vaccine matching Good BI confidence index Low BI confidence index Medium BI confidence index High BI confidence index Confidence Index: in vitro test results, combining r1 and heterologous VNT values, obtained with A GVII-2015 vaccine strain against A/ASIA/G-VII isolates q Vaccination of 5 cattle at standard dose with Aftopor q Homologous and Heterologous VN Titer (21 dpv) used to determine the BI confidence index q Results: High heterologous VN Titers and high r1 values show a good coverage amongst the A/ASIA/G-VII lineage18
- 9. Ø Results: Serology of the vaccinates on D21 shows a dose effect relation Ø Results: After challenge, most animals presented signs related to the route of inoculation. Only control animals presented hyperthermia at D25 A GVII-2015 vaccine in vivo potency PD50 q Aftopor vaccine formulated at reduced payload q Full dose, ¼ dose and 1/16 dose administrated in cattle (> 6 months old) q Homologous challenge on 21 dpv (intradermo-lingual ; 10000 cattle ID50) q Post challenge monitoring: rectal temperature and clinical signs Days (Vaccination D0, Challenge D21)MeanAbresponse (log10VNTiters) VN Titers kinetics 0 0.5 1 1.5 2 2.5 3 D0 D21 D29 G1 - 2 ml G2 - 0.5 ml G3 - 0.125 ml G4 - Control Reduced payload G1, G2, G3 = 5 animals G4 = 2 animals Temperature curves Meanrectaletemperature(°C) Days Challenge 38.0 38.5 39.0 39.5 40.0 40.5 41.0 41.5 42.0 D20 D21 D22 D23 D24 D25 D26 D27 D28 D29 G1 - 2ml G2 - 0.5ml G3 - 0.125ml G4 - Control
- 10. FMD specific lesions at necropsy Group FMD specific lesions at necropsy Protected animalsNumber of animals with feet lesions Number of feet affected per animal Number of animals with myocarditis G1 5 animals 1/1 dose 2 ml G2 5 animals 1/4 dose 0,5 ml G3 5 animals 1/16 dose 0,125ml G4 2 animals Controls A GVII-2015 vaccine in vivo potency PD50 Reduced payload
- 11. Group FMD specific lesions at necropsy Protected animalsNumber of animals with feet lesions Number of feet affected per animal Number of animals with myocarditis G1 5 animals 1/1 dose 2 ml 0 0, 0, 0, 0, 0 - 5/5 100% G2 5 animals 1/4 dose 0,5 ml 0 0, 0, 0, 0, 0 - 5/5 100% G3 5 animals 1/16 dose 0,125ml 2 0, 1, 1, 0, 0 - 3/5 60% G4 2 animals Controls 2 3, 1 * 2 0/2 0% * Early death of both animals (myocarditis V) - No mortality in the group Protected Not protected Conclusion: Potency of A GVII-2015 vaccine is established by challenge in cattle V V A GVII-2015 vaccine in vivo potency PD50 Reduced payload
- 12. The newly developed A GVII-2015 vaccine strain provides a well adapted solution to fight the A/ASIA/G-VII threat: ü Safe, benefiting from unique purification process ü Highly potent: Ø High homologous and heterologous antibody responses Ø High r1 values vs A/ASIA/G-VII isolates Ø Excellent in vivo Potency : 18PD50 ü Compliant with the highest quality standards of Good Manufacturing Practices and European Pharmacopeia ü Registered in EU and Middle East ü Commercialized as part of BI's FMD vaccines portfolio è A GVII-2015 vaccine strain is a new key tool to support FMD control A GVII-2015 : General Conclusion
- 13. Aldo Dekker Erwin Claassen Marie-France Pollet-Ogier Julien Bazin Amandine Bibard Benjamin Thenoz Nathalie Rotsztajn Pascal Hudelet Ben van Schaijk Jose Coco-Martin BI – ST VULBAS BI - PIRBRIGHT OS18 Acknowledgements BI - LELYSTAD BI - LYON Laure Mouton Florence Fraisse Thanks for your attention Mark Faithfull Guo Zhang