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African Horse Sickness Control Through Vaccination

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African Horse Sickness Control Through Vaccination African Horse sickness control through vaccination Baptiste DUNGU DVM PhD CEO Onderstepoort Biological Products Ltd. OBP Onderstepoort, Pretoria South Africa Layout Onderstepoort OBP AHS history Vaccine in the control of AHS Roadmap toward an effective safer DIVA AHS vaccine FVS OBP OVI Faculty of Veterinary Science Onderstepoort Biological Products Onderstepoort Veterinary Institute More than 50 different livestock vaccines and other biological products OBP…in short State owned company: commercial mandate 200 staff member More than 50 different biologics: 28 bacterial vaccines, 14 viral vaccines, 4 Protozoal (Blood) vaccines Autogenous vaccines 6 diagnostic reagents Therapeutic sera Culture media Production Capacity: more than 150 million doses annually Species covered: Cattle, Sheep, Goat, equine, poultry “What we wish to point out is that, as a scourge which annually causes immense loss to the Colonies, it behoves the authorities to take adequate and scientific means to combat it. As yet absolutely nothing is known about its etiology…it is manifest that until the cause is known we cannot hope to battle with the disease. The discovery of the haematozoon of tsetse-fly disease was a notable feather in the cap of the school of research at Cambridge. Cannot some pathologist from the most progressive of Universities help us in like manner with the paarde-ziekte when peace once more reigns from Cape Town to the Zambezi? (Anon., 1900). “ 6 7 | Onderstepoort Biological Products © | March 9, 2020 …are we running in circles? www.goldcircle.co.za Summerveld Training Centre at Shongweni. By 1915 •Virus •Inoculable but not contagious •Transmitted by blood sucking insects (mentions Culicoides but suspects mosquito) •Has to be a natural reservoir •Horses, dogs once recovered not viraemic •Prevention and cure •Identifies immunity as potentially the best option •Did first vaccinations using serum of recovered horse/mule with virus •Multiple serotypes “antigenic plurality”, some cross protection between certain types 9 Vaccine breakthrough, the 60 year project AHS historical distribution Egypt (1928, 1943, 1953, 1958, 1971), Palestine, Jordan, Lebanon, Syria (1944) Iran and Persian Gulf (1959-1961) Libya, Tunisia, Morocco, Algeria (1965-1967) Saudi Arabia (1989, 1997) Spain and southern Iberian Peninsula (1965-66, 1987-1991) Cape Verde Islands (1999) M Quan, 2014 AHS – THE DISEASE • Vector-borne Orbivirus infection (Reoviridae) of equidae, endemic in large parts of Africa • 9 different serotypes with some cross-neutralization • Notifiable disease, OIE Status; worldwide importance • Exceptional mortality rate in naïve horses • Up to 95% in horses and 50-70% in mules • Equus burchelli believed to be primary viral reservoir • Transmission primarily by biting midges of the genus Culicoides • Extent of favourable climatic conditions for breeding of Culicoides • Most serious outbreaks often during March and April • C. imicola: 98% of all species in trap catches at Onderstepoort and AHSV repeatedly isolated • C.bolitinos: implicated as vector in a number of outbreaks AHS - SUSCEPTIBILITY Equids - Horses Resistant Mules Donkeys 10% Zebra Canines 50-70% 70-95% Susceptible African horsesickness virus 10 proteins 10 dsRNA Outer capsid pro- genes VP1 teins VP5 & VP2 1 VP2 2 VP3 3 4 VP4 5 VP5 6 NS1 7 NS2 8 VP6 9 VP7 Core protein VP7 Minor core proteins 10 NS3 Why is AHS still a problem? • The virus and vectors are endemic in SA & large parts of Africa • Inadequate immunity • No sustained vaccination • Wrong advice and wrong use of vaccine • Uncontrolled movement of horses • Weaknesses in surveillance AHS Control in South Africa Surveillance, Vaccination and Movement control Due to nature of current AHS LAV, vaccination restricted to low vector seasons With a non-replicating vaccine, the vaccination program could be modified in allowing more flexibility on time and animals to be vaccinated The virus is endemic in SA AHSV PCR submissions 2017+18 Total: 776 Positive 2017: 137/363 2018: 123/413 Serotypes per season 35 30 25 20 15 10 5 0 1 2 3 4 5 6 7 8 9 2016 - 2017 2017 - 2018 AHS-attenuated live virus (ALV) Vaccine since 1994 AHS Bottle I AHS Bottle II Cross reaction Serotype 1 Serotype 2 1 ↔ 2 Serotype 3 Serotype 6 3 ↔ 7 Serotype 4 Serotype 7 4 Serotype 8 5 ↔ 8 6 ↔ 9 • Exclude serotype T5 and T9 • T5 was omitted as vaccinated foals suffered severe reactions and death. Follow-up vaccination studies showed that the combination of T4 and T5 in bottle I was the cause. • T9 is low-immunogenic and was rare in southern Africa until recently AHS ALV vaccine challenges Risk of reassortment Not in pregnant animals Restricted for low vector periods Not recommended in high vector periods or during outbreaks No DIVA May not be suitable for epizootic situations or free countries Vaccination may be considered as an “infection” (OIE status) Vaccine produced in Senegal for example comprises all 9 serotypes… AHS free AHS endemic AHS vaccine manufacturer New vaccine? Why? Current vaccine Attribute Comply Protection to all serotypes > 90% animals protected Duration of immunity ≥ 1 year Safety ? Storage, transport temperature 4°C Enzootic & epizootic use × Marker vaccine (DIVA) × Traditional vaccine • Live attenuated technologies: • Inactivated vaccines • Live Disabled Single Infection Cycle (DISC) AHS vaccine vaccines: (VP6-deficient AHSV strains) New technologies • Live Disabled Single Animal (DISA) vaccines (based on (NS3/NS3a-deficient AHSV strains) technologies • Inactivated (capsid swap) vaccines Technology • Sub-unit adjuvanted vaccines to date Review report by • Canarypox virus expressing AHSV-VP2 and J. Castillo): AHSV-VP5 • Modified Vaccinia Ankara (MVA) expressing AHSV-VP2 Other • Plant expressed AHS-VLP expressed in plant (University of technologies Cape Town, funded by DST) IHSC driven process for the Glossary of terms Executive Summary development of a DIVA AHS Background to the Process Approach used vaccine Roadmap toward the development of a DIVA AHS vaccine Desired Characteristics for the DIVA AHS vaccine Target Product Profile (TPP) AHS vaccine technology review Vaccination strategy overview Market and economic aspects review Stakeholders inputs & key partnerships for AHS DIVA vaccine development Candidate vaccines selection for the medium term Inactivated AHS vaccines Canarypox vaccine candidate MVA-VP2 vaccine Plant expressed AHS VLP vaccines Critical activities for the development of the AHS DIVA vaccine Approved experimental vector-proof horse stables Challenge model and studies Timelines for the development of the selected candidate Funding and funding models Partial funding (pump-priming) Funding of specific candidates Legal and regulatory needs Recommendations for the Way forwards beyond the present process • Profile of the most desirable characteristics: out of TPP • Protection to all 9 serotypes • DIVA • Flexible for use as monovalent in case of defined outbreaks or epidemics • Flexible for use in different combinations based on specific epidemiological situation (2 to 3 serotypes in certain regions) • Effective on all equids and possibly all susceptible animals (e.g. camels) • Safe for use in horses of all ages and all physiological stages (pregnant, young etc.) • Adaptable to different vaccination programs: high performance, working horses, movement of horses to and from endemic regions, emergency vaccination etc. • Affordable to different types of equids Most important desired characteristics Attribute Minimum Ideal 1 Antigen immunogens protective to AHSV infection Immunogens protective to all 9 serotypes of AHSV Detailed 2 Indication for use For active immunisation of horses against For active immunisation of equids (incl. mules and donkeys) of AHSV all ages and physiological conditions against all 9 serotypes of desired AHS AHSV. Suitable for immunization of wild equids DIVA vaccine Epidemiological relevance Suitable for protection of horses in AHS Suitable for protection of equids in enzootic and epizootic enzootic regions regions, including immunisation of equids being moved between characteristics: regions of different AHS status EFFICACY Expected efficacy To prevent disease in > 70% of vaccinated To prevent infection in > 80% of vaccinated animals Target Product animals Immunity spectrum Protection to all 9 serotypes Equal protection to all 9 serotypes with possibility of individual Profiles serotype protection 5 Onset of immunity Within 3 weeks of complete vaccination Within 10 days following complete vaccination 6 Route of administration Subcutaneous (SC) or Intramuscular (IM) Intramuscular 7 Regimen - vaccination Yearly vaccination to include primo and Yearly vaccination to include primo and booster doses booster doses 8 Recommended age at first vaccination As early as possible 9 Duration of immunity Minimum of 12 months Protection to all serotype for at least one year SAFETY 10 Expected safety Mild and transient injection site reactions Mild and transient injection site reactions and pyrexia lasting and pyrexia lasting less than 14 days in up to less than 7 days in up to 10% of vaccinated animals. 20% of vaccinated animals. 11 Reproductive safety No for milk, 4 weeks for meat Suitable for all stages of pregnancy Suitable for stallions at any stage 12 Environmental safety No vaccine derived infectious material detectable… 14 Reassortment risk Demonstrated inability to reassort with Structurally incapable of reassorting with other viruses wildtype AHSV DIVA 15 Detection of infection Detection of infection in vaccinated
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