Đề tài Development of an Improved Capability in support of National Bio-Security for the Surveillance and Control of Foot & Mouth Disease in Cattle and Pigs

The aims of this project were to develop capacity for FMD diagnosis, surveillance and control at both a laboratory and field level within the wider animal health network in Vietnam. Improved diagnostic capacity will faci litate early detection and identification of FMD enabling better disease control. Specifically, successful capacity development at regional laboratories will enable quality assured laboratory capability for FMDV diagnosis and serology. This will be applied to the investigation of FMDV serotypes currently in circulation, vaccination coverage/response and the elucidation of on-going suspected FMD vaccine failures in Vietnam. In addition, the successful establishment of an effective laboratory network for the diagnosis and control of FMD will provide a greater understanding of FMD epidemiology and will facilitate the coordination and implementation of effective vaccination control strategies via the wider animal health network in Vietnam.

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Ministry of Agriculture & Rural Development Completion Report1 Development of an Improved Capability in support of National Bio-security for the Surveillance and Control of Foot & Mouth Disease in Cattle and Pigs. Chris Morrissy 1 Submitted July 2010 Table of Contents 1. Institute Information ____________________________________________ 1 2. Project Abstract _______________________________________________ 2 3. Executive Summary ____________________________________________ 2 4. Introduction & Background ______________________________________ 4 4.1 Objectives of the project ___________________________________________ 4 4.2 Implementation Approach and Strategy ______________________________ 4 5. Progress to Date _______________________________________________ 5 5.1 Implementation Highlights _______________________________________ 5 5.2 Smallholder Benefits ________________________________________ 7 5.3 Capacity Building ___________________________________________ 7 5.4 Publicity __________________________________________________ 8 5.5 Project Management ________________________________________ 8 6. Report on Cross-Cutting Issues __________________________________ 9 6.1 Environment _______________________________________________ 9 6.2 Gender and Social Issues ____________________________________ 9 7. Implementation & Sustainability Issues ____________________________ 9 7.1 Issues and Constraints ______________________________________ 9 7.2 Options ___________________________________________________ 9 7.3 Sustainability _____________________________________________ 10 8. Next Critical Steps ____________________________________________ 10 9. Conclusions__________________________________________________ 11 9.1 Acknowledgements ______________________________________________ 12 10. Statuatory Declaration _________________________________________ 14 11. Project progress against proposed objectives, outputs, activities and inputs ____ ___________________________________________________16 1 1. Institute Information Project Name CARD FMD [072/04VIE] Vietnamese Institution Regional Animal Health Office (RAHO-6) Ho Chi Minh City South Vietnam Vietnamese Project Team Leader Dr Dong Manh Hoa Australian Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220 Australia Australian Personnel Mr Chris Morrissy Date commenced 01/06/2005 Completion date (original) 01/06/2008 Completion date (revised) Reporting period Project Completion Report Contact Officer(s) In Australia: Team Leader Name: Mr Chris Morrissy Telephone: +61 3 5227 5000 Position: Supervisor Mammalian Virology Fax: +61 3 5227 5555 Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220, Australia Email: chris.morrissy@csiro.au In Australia: Administrative Contact Name: Mr Christopher Morrissy Telephone: +61 3 5227 5434 Position: Patents Contracts Officer Fax: +61 3 5227 5555 Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220 Australia Email: christopher.morrissy@ csiro.au In Vietnam Name: Dr Dong Manh Hoa Telephone: + 84 8 8568220 Position: Director Fax: + 84 8 8569050 Organisation Regional Animal Health Office (RAHO-6) Ho Chi Minh City South Vietnam Email: rahchcmc@hcm.vnn.vn 2 2. Project Abstract The aims of this project were to develop capacity for FMD diagnosis, surveillance and control at both a laboratory and field level within the wider animal health network in Vietnam. Improved diagnostic capacity will facilitate early detection and identification of FMD enabling better disease control. Specifically, successful capacity development at regional laboratories will enable quality assured laboratory capability for FMDV diagnosis and serology. This will be applied to the investigation of FMDV serotypes currently in circulation, vaccination coverage/response and the elucidation of on- going suspected FMD vaccine failures in Vietnam. In addition, the successful establishment of an effective laboratory network for the diagnosis and control of FMD will provide a greater understanding of FMD epidemiology and will facilitate the coordination and implementation of effective vaccination control strategies via the wider animal health network in Vietnam. 3. Executive Summary On completion, this project has realised all laboratory-based objectives at a national level. However, due to the lack of epidemiology support and the diversion of DAH resources to deal with outbreaks of AI and PRRSV, field-dependent objectives were only achieved to a varying extent throughout Vietnam as a whole. Nevertheless all project objectives were fully realised and with great effect in southern Vietnam. Despite considerable achievements on a regional basis, this project clearly demonstrates the consequences of not having a fully integrated FMD diagnostic and surveillance network at a national level. In relation to FMD capacity development and sustainability, one of the primary aims of this project was to “highlight the importance of having an integrated laboratory network to identify what is happening in the field and how to prevent and control outbreaks”. This project on a national scale was undoubtedly ambitious. Indeed this was the intention and in this respect the project has been highly effective. For example, the considerable success achieved in southern Vietnam has highlighted RAHO-6 as an exemplar to DAH. In addition, the success achieved by RAHO-6 will act as an impetus to other regional offices in relation to the requirement for closer integration and clear, effective, two- way communication between laboratory and field-based personnel. During the course of the project there was a clear improvement and advances in both laboratory and field-based activities for the diagnosis and control of FMD. The AAHL Scientific Coordinator has mentored and liaised extensively with four diagnostic laboratories; RAHO-6 [HCMC]; NCVD [Hanoi]; RAHO-7 [Can Tho]; RAHO-4 [Da Nang] and one research laboratory, NAVETCO [HCMC]. As a result of successful capacity development and technology transfer from AAHL the RAHO-6 and NCVD laboratories now possess comprehensive, quality assured capabilities to diagnose FMD and perform sero-surveillance. In addition, both laboratories are capable of performing FMD virus isolation, virus neutralisation, ELISAs, PCR and sequencing/genotyping for the characterisation of FMD field isolates. All FMD laboratory diagnostic capabilities have been subject to internal quality assurance following on-site appraisal by the AAHL Scientific Coordinator using reference reagents supplied by AAHL and also external quality assurance using PT Panels from both AAHL and the FMD Regional Reference Laboratory in Thailand as detailed in earlier Milestone reports. This has resulted in the recognition of both RAHO-6 and NCVD as FMD Reference Laboratories in Vietnam. 3 In addition, quality assured FMD diagnostic capability in the form of the AAHL FMD Ag ELISA [for the detection of virus] and both the AAHL FMD C-ELISA and LP- ELISA [for post-vaccination surveillance] have been successfully established at both RAHO-4, RAHO-7 and NAVETCO. Following the establishment of comprehensive FMD diagnostic, virus isolation and serotyping capability at RAHO-6 tests have been implemented with both zeal and determination and of particular significance, with a long-term strategic vision. For example, the isolation and propagation of FMD serotypes in cell culture has been used by RAHO-6 to produce their own FMD antigens for in-house ELISA use and are distributing this antigen for use in other regional laboratories in Vietnam. In addition, ongoing sero-surveillance, vaccine efficacy monitoring and the serotyping of FMD field isolates has facilitated the evidence-based selection of the most appropriate FMD vaccine serotype composition and the identification of disease incursions from adjacent countries. As detailed in earlier Milestone Reports, central to the achievement of project objectives in regions such as southern Vietnam was the close integration of laboratory and field-based activities. Overall, there was a significant improvement in the amount of data and quality of field specimens submitted to the laboratories over each surveillance round. This reflected a greater appreciation of the importance of high quality field data and clinical specimens for FMD surveillance and control by regional laboratories. The realisation of project objectives in regions such as southern Vietnam was greatly facilitated by the leadership, focus and vision of the main collaborating laboratory / office, RAHO-6. In particular, the establishment and support of an epidemiological unit at RAHO-6 as a result of this project has greatly assisted in the training of epidemiologists and field veterinarians in FMD sero- surveillance, outbreak control and disease investigation including vaccine failure. During the course of this project, this closer integration, collaboration and communication between RAHO-6 laboratory / office and field personnel in southern Vietnam has facilitated the acquisition of the necessary high quality field data and clinical specimens. This highly effective two-way integration has resulted in an every decreasing incidence of FMD outbreaks in southern Vietnam with only one isolated outbreak being detected in the 2009-2010 reporting period. This significant achievement has been noted by DAH, attests to the effectiveness of the project implementation approach, and highlights the successful RAHO-6 “lab-to-field” and “field-to-lab” integration as an exemplar to other regional laboratories / offices. Sero-surveillance and epidemiological studies have enabled the acquisition of important data in relation to vaccine coverage, the serotyping of FMD field isolates and the prevalence of FMD infection in Vietnam. This data has enabled driven science-based changes in vaccine recommendations to be made with great effect in the field. This project has not only been of benefit to Vietnam but has also lead to a greater knowledge and understanding of circulating FMDV genotypes and the benefits of sero-surveillance for the whole region. In acknowledgement of the significance of this work, project participants have been invited to a number of regional [SEAFMD LabNet 2010; SEAFMD LMWG 2008] and international meetings [EU-FMD; OIE Subcommittee 2010] to present Vietnam’s highly effective implementation strategy for the control of FMD. Of particular significance, it should be noted that as a result of this project Vietnam is recognised internationally as model example to other counties in the region in relation to the successful implementation of FMD diagnostic tests, sero-surveillance, outbreak investigations and disease control. 4 4. Introduction & Background 4.1 Objectives of the project: 1. To establish an effective laboratory network for the diagnosis and control of FMD by the provision of resources and training of staff in required methods and quality assurance. 2. To provide accurate data to explain failure of vaccination to control FMDV and to develop new effective vaccine application strategies. Completing these objectives will improve the diagnostic capability of veterinary laboratories in Vietnam and achieve training of DAH veterinarians in disease investigation and control. This will strengthen both the role and the profile of DAH which will play a vital role in making Vietnam more economically competitive. In addition, improved animal health will lead to an increase in rural productivity though increased animal production. Healthy animals will enable small farmers to be more competitive in the local market and the control of FMD will reduce poor farmers’ vulnerability to FMD outbreaks and result in a more stable income stream. Establishing a diagnostic network which extends from the North to South Vietnam, from the laboratory to the farm level, reinforced by training and education, will give Vietnam a more integrated animal health network and greatly facilitate disease control. This will directly increase the competitiveness and productivity of the national agricultural system which includes the major areas of concern including the Mekong Delta and the Central Coast. 4.2 Implementation Approach and Strategy The approach for technology transfer is well established at AAHL and has been successfully applied in previous projects in Vietnam, Thailand and Indonesia. The project approach used was also thought to be the most appropriate for developing an understanding of FMD epidemiology in Vietnam. All studies were designed in conjunction with DAH with the aim to provide the critical information in relation to current FMD status in Vietnam and the effectiveness of FMD vaccine usage in the field. The diagnostic technologies that will be used in this approach are the standard OIE diagnostic tests in use throughout the world to study, control and eradicate FMD. AAHL has extensive experience in FMD technology transfer and capacity development including the implementation of field surveys for the measurement of the prevalence of antibodies against FMD such as earlier ACIAR projects in Laos and Thailand. 5 5. Progress to Date 5.1 Implementation Highlights [Upon Project Completion] The main achievements of the project were: • Successful capacity development for the diagnosis, surveillance and control of FMD in Vietnam. Specifically, the following quality assured FMD diagnostics were established in the collaborating laboratories:  RAHO6 and NCVD laboratories have established comprehensive cell culture, virus isolation, virus neutralisation test, ELISA, PCR, sequencing/genotyping capability • It should be noted that both RAHO-6 and NCVD have achieved FMD Reference Laboratory status in Vietnam  RAHO4, RAHO7 and NAVETCO laboratories also have the capability for FMD diagnosis and serology by ELISA for post-vaccination surveillance  All laboratories in the project are able to utilise the AAHL LP-ELISA, C- ELISA and 3ABC ELISA to establish the sero-prevalence of FMD in herds and vaccine coverage post-vaccination  All laboratories have implemented an in-house Quality Assurance system to monitor the accuracy of test results • The project has both driven and inspired an increase in collaboration between the Vietnamese laboratories and helped nurture a more integrated animal health laboratory network  This will be essential not only for the control of FMD and has since been applied to other animal diseases such as resent PRRSV outbreaks in Vietnam • Improvement in the quality and number of samples submitted to the laboratory for serotyping by ELISA.  The closer integration of laboratory and field-based personnel, e.g. as achieved by RAHO-6, combined with improved diagnostic capacity and capability throughout Vietnam has led to the serotyping of a greater number of clinical specimens at both RAHO-6 and NCVD  In addition, the significant improvement in sample collection and specimen submission has allowed virus isolation from field samples. This was not been possible prior to the initiation of this project and of particular significance has enabled genotyping of FMDV field isolates  This has enabled DAH to achieve a greater understanding of the serotypes of FMD viruses circulating in Vietnam and provided essential baseline data in relation to the future control of FMD throughout Vietnam 6 • Genotyping and analysis of approx. 100 Vietnamese FMD field isolates collected from 2006 onwards  Genotyping data was detailed in Appendix 1 of the earlier Milestone 3 report  Sequence data was sent to WRL for additional confirmation and comparison to other FMD isolates  This information was shared with SEAFMD as part of the regional project to control FMD  Genotyping has elucidated the reason underlying vaccine failures in the field and has successfully established capability in Vietnam to determine the source of a FMD outbreak and to make evidence-based decisions in relation to whether the current vaccine serotype compositions are appropriate.  Genotyping, combined with the ability to carry out VNT for determining antigenic variation of field isolates, has enabled Vietnamese laboratories to investigate future vaccine failures  Of particular significance, this has already resulted in the elucidation of vaccine failures in the field as a result of inappropriate vaccine composition usage as detailed in the earlier Milestone 8 Report • Standard forms and protocols for collection of field data and trained field veterinarians in how to carry out disease investigation for control of disease and vaccine failure • A model approach for a program to control FMD with a strong laboratory and field component • Throughout the project AAHL consultants have mentored and liaised extensively with collaborating laboratories to achieve the following:  Established a comprehensive portfolio of internally and externally quality assured FMD diagnostic techniques at the newly established FMD Reference Laboratories at RAHO-6 and NCVD and related quality assured FMD ELISAs at all participating laboratories  Appraised quality assurance records and data collection under in-house QA systems to ensure test records were being maintained and results were interpreted correctly  Established and appraised cell culture and virus isolation capability for growth of FMD isolates from the field which has enabled further genotyping of FMD field isolates  Validated an in-house ELISA using FMD antigen produced at RAHO-6 using Vietnam isolates. The production and supply of this antigen to other laboratories facilitates future sustainability  Established and appraised molecular techniques to ensure best practice workflow for FMD diagnostic PCR under local conditions  Provided advice on the design and format of sample submission, data collection forms and outbreak investigation surveys to facilitate the acquisition of high quality field data and specimen submissions  Analysed and interpreted field and laboratory data 7  Supplied consumables, reference IQC reagents and EQA PT reagents to confirm successful establishment of quality assured FMD diagnostic tests  On-going appraisal of laboratory quality assurance procedures and advice in relation to individual laboratory quality assurance manuals and SOPs 5.2 Smallholder Benefits All pig and cattle and producers are potential beneficiaries. To date, revised vaccine recommendations, made based on the serotyping and genotyping of Vietnamese FMDV field isolates have already resulted in improved vaccine strategies in the field and during the course of this project has facilitated a significant reduction in the incidence of FMD outbreaks in Vietnam. On-going FMD surveillance, serotyping and genotyping of field isolates will continue to improve the effectiveness of tailored vaccination strategies in the field in Vietnam. This will continue to be of financial benefit to small farmers through reduced losses due disease in their cattle and pigs. DAH personnel, district veterinarians and farmers have gained improved knowledge and appreciation with regard to the selection of the most appropriate vaccine serotype[s] composition which will improve the efficacy of vaccination and the realisation of long-term goals in relation to the control o