Swine Vesicular Disease - available

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Control Tools

Diagnostics availability

Commercial diagnostic kits available worldwide

Currently Prionics is the only Company that commercializes an ELISA kit for detection of antibodies in serum and plasma. Reagents for antigen detection based on ELISA and for antibody detection by competitive ELISA (as described in the OIE manual) are available from the two OIE reference laboratories.

Commercial diagnostic kits available in Europe

Currently Prionics is the only Company that commercializes an ELISA kit for detection of antibodies in serum and plasma. Reagents for antigen detection based on ELISA and for antibody detection by competitive ELISA (as described in the OIE manual) are available from the two OIE reference laboratories.

Diagnostic kits validated by International, European or National Standards

The 5B7-competitive ELISA for antibody detection reported in the OIE manual underwent extensive validation in several EU National Reference laboratories, before being considered as the reference screening test.

Diagnostic method(s) described by International, European or National standards

All assays mentioned at 9.3 section are described in the EC Decision 2000/428 and in the O.I.E. Manual of Diagnostic tests and vaccines for terrestrial Animals.

Commercial potential for diagnostic kits in Europe

Low, unless surveillance programmes are implemented.

DIVA tests required and/or available

Not required as vaccine not authorised or used in Europe.

Opportunities for new developments

Currently available diagnostic tests are valid tools. In the prospect of herd health status profiling or implementation of serosurveillance programmes for multiple diseases, the development of multiple simultaneous assays on the same sample, including SVDV antibody detection, could be seen as an opportunity.

GAPS:

Rather than new developments, a modification of recommendations for use of available tests should be considered. For example, extensive experience suggests that for antibody detection ELISA may be more reliable and robust than VNT, so that there is no need to confirm by VNT multiple positive samples detected by ELISA. VNT can remain as reference test only to discriminate the singleton cases. Similarly, RT-PCR proved to be more sensitive and reliable than virus isolation (indicated as the gold standard test).

Vaccines availability

Commercial vaccines availability (globally)

None.

Commercial vaccines authorised in Europe

None and not permitted to use vaccines.

Marker vaccines available worldwide

None.

Marker vaccines authorised in Europe

None.

Effectiveness of vaccines / Main shortcomings of current vaccines

Not applicable as no vaccines in use.

Commercial potential for vaccines in Europe

None.

Regulatory and/or policy challenges to approval

Not applicable at present.

Commercial feasibility (e.g manufacturing)

No clear market.

Opportunity for barrier protection

Barrier protection not applicable by vaccination.

Opportunity for new developments

Not required based on vaccine availability considerations.

Pharmaceutical availability

Current therapy (curative and preventive)

None.

Future therapy

None.

Commercial potential for pharmaceuticals in Europe

None.

Regulatory and/or policy challenges to approval

Not applicable.

Commercial feasibility (e.g manufacturing)

Not required.

Opportunities for new developments

Not applicable, not required.

New developments for diagnostic tests

Requirements for diagnostics development

Extended sequencing of isolates would help in selection of best matching primers for application in new RT-PCR assays.

Time to develop new or improved diagnostics

1-2 years for the mentionned requirement (Extended sequencing of isolates).

Cost of developing new or improved diagnostics and their validation

Cost would be affordable; human resources and expertise more demanding.

Research requirements for new or improved diagnostics

In the prospect of herd health status profiling or implementation of serosurveillance programmes for multiple diseases, the development of multiple simultaneous assays on the same sample, including SVDV antibody detection, could be seen as an opportunity. Extended sequencing of isolates would help in selection of best matching primers for application in new RT-PCR assays.

Technology to determine virus freedom in animals

New developments for vaccines

Requirements for vaccines development / main characteristics for improved vaccines

Not required.

Time to develop new or improved vaccines

Not applicable.

Cost of developing new or improved vaccines and their validation

High.

Research requirements for new or improved vaccines

None at present.

New developments for pharmaceuticals

Requirements for pharmaceuticals development

None.

Time to develop new or improved pharmaceuticals

Not applicable.

Cost of developing new or improved pharmaceuticals and their validation

Not applicable.

Research requirements for new or improved pharmaceuticals

None.

Disease details

Description and characteristics.

Pathogen

Swine Vesicular Disease virus (SVDV) is a member of the genus Enterovirus within the family Picornaviridae, and is a porcine variant of the human pathogen coxsackie B5 virus. The virus has a positive sense single-stranded RNA genome encoding four capsid proteins (VP1, VP2, VP3 and VP4) assembled in a capsid of icosahedral symmetry, and several non-structural proteins.

Variability of the disease

SVDV occurs as a single serotype, in which four congruent groupings were found in both the genetic and antigenic properties of the virus. The most recent group consists of viruses isolated from the European Union since 1992. Isolates of this variant collected in a 20-year period showed a gradual nucleotide substitution rate, while the antigenic profile maintained stable. SVDV is unrelated to other porcine enteroviruses. Phylogenetic studies suggest that it evolved as a genetic sub-lineage of the human pathogen coxsackievirus B5 to which it is antigenically related.

Stability of the agent/pathogen in the environment

Temperature: 

Generally very stable

Preserved by refrigeration and freezing, inactivated by  56°C/1 hour.

pH:

Resistant at pH 2 - 12.

Disinfectants: 

In the environment and in the presence of organic matter, SVDV is inactivated by sodium hydroxide 1%; benzalkonium chloride, formaldehyde, sodium hypochlorite and oxidising agents may also be suitable but require longer action time. For personal disinfection in the absence of gross organic matter, disinfectants, such as oxidising agents, iodophores, acids combined with detergent are suitable.

Survival: 

SVDV is extremely resistant and can survive for several months in the environment. Resistant to fermentation and smoking processes. May remain in hams for 180 days, dried sausages for >1 year, and in processed intestinal casings for >2 years.

Species involved

Animal infected/carrier/disease

Swine (domestic and wild pigs) are the only susceptible species. The carrier state was experimentally shown to be a very rare sequel to infection with SVD virus and is therefore not significant in the epidemiology of the disease.

Human infected/disease

SVD virus has evolved from the human enterovirus coxsackievirus B5 to which it is antigenically related, but transmission of CV-B5 between pigs does not occur. Serconversion or disease was never reported in farmers or veterinarians working with infected pigs; however seroconversion in humans has rarely occurred in laboratory workers associated with mild flu-like clinical disease, with exception of one case of meningitis.

Vector cyclical/non-cyclical

None.

Reservoir (animal, environmental)

Pigs are the only species that are naturally infected. No reservoir hosts are known.

Description of infection & disease in natural hosts

Transmissibility

Direct contact with infected pigs or indirect contact via contaminated materials, environment, fomites. Transmission route: oral (main), skin and mucosal lesions. Infectious sources: faeces (major), vesicular fluid, contaminated meat scraps and swill. Airborne transmission of SVDV is insignificant.

Pathogenic life cycle stages

Not applicable.

Signs/Morbidity

SVD is characterised by development of vesicles on the coronary band (sometimes resulting in loss of the hoof), interdigital spaces, and occasionally on snout, lips, tongue and teats; shallow erosions may be seen on the knees. Pigs may become temporarily lame and refuse to move even for food. Transient fever up to 41°C may occur. Recovery is usually complete within two to three weeks.

The disease may be subclinical, mild or severe, depending on the strain of virus involved, the route and dose of infection, and the husbandry conditions. Morbidity rate in herds may be low but high in pen/contact groups. The main importance of SVD is that it is clinically indistinguishable from foot and mouth disease and other vesicular diseases. However, outbreaks of SVD that have occurred during recent years have been characterised by less severe, or no clinical signs.

Incubation period

The incubation period is between 2 and 7 days.

Mortality

Mortality due to SVD is very rare.

Shedding kinetic patterns

Affected pigs may excrete virus from the nose and mouth and in the faeces up to 48 hours before the onset of clinical signs. Most virus is produced in the first 7 days after infection, and virus excretion from the nose and mouth normally stops within 2 weeks. Virus may continue to be shed for up to 3 months in the faeces. All tissues contain virus during the viraemic period.

Mechanism of pathogenicity

SVD virus has a tropism for epithelial tissue (skin and mucosa of digestive tract). Vesicle formation is the only known lesion directly attributable to the infection.

Zoonotic potential

Reported incidence in humans

Very few human cases have been reported several years ago in laboratory workers with contact with SVDV, but never in farmers or veterinarians working with infected pigs.

Estimated level of under-reporting in humans

None

Risk of occurence in humans, populations at risk, specific risk factors

Almost none

Symptoms described in humans

Clinical signs included mild influenza-like symptoms (fever, malaise) with generalized abdominal and muscle pain and weakness. One case developed into aseptic meningitis. All human cases recovered without sequelae.

Likelihood of spread in humans

None

Impact on animal welfare and biodiversity

Both disease and prevention/control measures related

At present, SVD has often a sub-clinical course and usually the direct impact of the disease in pigs is quite low. The restriction of animal movement (protection and surveillance zones) may cause sanitary and welfare problems.

Endangered wild species affected or not (estimation for Europe / worldwide)

No.

Slaughter necessity according to EU rules or other regions

Yes (according to EU legislation).

Geographical distribution and spread

Current occurence/distribution

SVD was first recorded in Italy in 1966. Later, outbreaks occurred in several European countries and Eastern Asia during the 1970s, early 1980s; then the disease has continued to persist in Italy until the present day and has reappeared in the European Union, outside Italy, on sporadic occasions since 1992. Apart from Italy, where SVD is mostly diagnosed in clinically normal pigs, nowadays the EU is considered free, in most countries uniquely on the basis of absence of clinical evidence. Uncertainty remains on the presence of SVD in some countries in Asia.

GAP: due to the prevalent sub-clinical course of the disease, clinical inspection is often ineffective; so that it is necessary to resort to laboratory diagnosis for SVD surveillance. The extent of occurrence of SVD virus outside of Italy is not absolutely clear, since most countries do not undertake the extensive laboratory-backed surveillance needed to be sure of freedom.

Epizootic/endemic- if epidemic frequency of outbreaks

Apart from very sporadic clinical cases in Europe, SVD is endemic in southern Italy with occasional outbreaks or rarely epidemic waves in central or northern regions, from where it has been rapidly eradicated.

Seasonal cycle (seasonality)

No

Speed of spatial spread during an outbreak

SVD diffusion is mainly related to movement of pigs, means of transport and contaminated material and personnel. High herd density may also play a role in spread between herds. However, SVD may have a limited tendency to spread even within pens of the same farm.

GAP: bio-security measures based on principles of direct prophylaxis are not always correctly implemented to prevent incursion of SVD in a farm or in a “new territory”.

Transboundary potential of the disease

SVD is a transmissible disease that has the potential for very serious and rapid spread, irrespective of national borders.

GAP: increased risk due to subclinical course of disease.

Seasonal cycle linked to climate

No

Distribution of disease or vector linked to climate

No

Outbreaks linked to extreme weather

No

Sensitivity of disease or vectors to the effects of climate change (environmental changes/land use)

No

Route of Transmission

Usual mode of transmission (introduction, means of spread)

Direct contact with infected pigs or indirect contact via contaminated materials, environment, personnel, fomites. Faecal contamination is a major source of virus spread, often within contaminated vehicles.

Occasional mode of transmission

Via contaminated meat scraps and swill.

Conditions that favour spread

Overcrowding, mixing and transporting animals, transport of pigs in contaminated lorries.  Late diagnosis, non clinical infection.

GAP: the undisclosed course of SVD may facilitate its diffusion.

Detection and Immune response to infection

Mechanism of host response

Humoral response with development of virus neutralizing antibodies is the most important, known mechanism of host reaction to infection.

GAP: in the absence of pressure to develop a vaccine, immunological research has not been a priority.

Immunological basis of diagnosis

Detection of specific antibodies in serum, by ELISA and Virus Neutralisation test, is indicative of present or past infection. On the basis of the typical kinetics of occurrence for the different immunoglobulins, antibody isotyping is useful to ascertain the time of exposure to infection; detection of IgM is indicative of current infection within a pig herd.

Main means of prevention, detection and control

Sanitary measures

EU legislation provides for: stamping out, restriction of pig movements (protection and surveillance zones), cleansing and disinfection, restrictions on swill feeding and on importation of pig products from SVD-affected regions.

GAP: in many countries SVD detection is based on clinical evidence. SVD has often a sub-clinical course and when the disease is identified it may have already spread. 

Mechanical and biological control

Stamping out and destruction of affected and in contact pigs, standstill, cleansing and disinfection

Diagnostic tools

The diagnosis of SVD requires the facilities of a specialised laboratory. In case of clinical occurrence, differential diagnosis with FMD is essential, and due to the common subclinical course, laboratory investigations are the only mean to scientifically exclude virus circulation.

Diagnostic tests for virus detection:

  • virus isolation in susceptible cell cultures accompanied by an identification assay,
  • RT-PCR;
  • ELISA for antigen detection (only suited for vesicular tissue and virus identification in infected cultures)

Diagnostic tests for antibodies detection:

  • Competitive ELISA (based on monoclonal antibody) as screening test    
  • Virus Neutralization test as confirmatory test
  • Isotype specific ELISA, for IgG and IgM identification

GAPS: 

Available diagnostic tests are valid tools; rather than gaps, a modification of recommendations for use should be considered. For example, extensive experience suggests that for antibody detection ELISA may be more reliable and robust than VNT, so that there is no need to confirm by VNT multiple positive samples detected by ELISA. VNT can remain as reference test only to discriminate the singleton cases. Similarly, RT-PCR proved to be more sensitive and reliable than virus isolation (indicated as the gold standard test). 

Vaccines

There is currently no commercial vaccine available against SVD. Vaccination is forbidden in EU.

Experimental inactivated vaccines against SVDV have been developed but vaccination of pigs has never been undertaken in the field.

Therapeutics

None

Biosecurity measures effective as a preventive measure

Health status certification (holding/animal/product), application of rigorous cleansing and disinfection procedures.

GAP: the health status certification (farm/animal) may be proved by appropriate lab investigations

Border/trade/movement control sufficient for control

Certification on the origin of the animals/product plus health status certification.

GAP: certifications are based on the surveillance activities performed, at present there are not harmonized surveillance rules.

Prevention tools

Health status certification (holding/animal). Application of rigorous cleansing and disinfection procedures. Control on animal movements. Ban on swill feeding.

GAP: on the basis of clinical symptoms, it may be difficult to recognize affected animals, also during the acute phase. 

Surveillance

At present, in many countries surveillance for SVD is based on clinical evidence. Since SVD has often a sub-clinical course, clinical surveillance must be supported by appropriate sampling and laboratory investigations such as serological surveillance and/or detection of SVDV in random sampling of pen-floor faeces.

GAP: Surveillance in the EU is based on the assumption that in case SVD enters a susceptible population, clinical symptoms are observed. According to the knowledge acquired on the disease, clinical surveillance has a low sensitivity for detecting virus circulation.

Past experiences on success (and failures) of prevention, control, eradication in regions outside Europe

A number of European and Far Eastern countries have eradicated SVD in the 70’s, 80’s and 90’s.  Since then the only reported cases were in Taiwan (2000), in Portugal (2002, 2004, 2007) and Italy (still present). In case of outbreak, EU legislation provides for a rigorous stamping out policy.

GAP: due to the frequent subclinical nature of SVD virus infection and the lack of information on surveillance, the global distribution of the virus cannot be ascertained with certainty.

Costs of above measures

Nowadays the cost of SVD is mainly linked to the control measures applied (stamping out…) and to the stringent control on trade, rather than to the real outcome of the disease in susceptible species (morbidity is very low, mortality is nil).

GAP: control measures applied seem disproportionate to the real impact of the disease.

Disease information from the OIE

Disease notifiable to the OIE

Yes

OIE disease card available

http://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/SWINE_VESICULAR_DISEASE_FINAL.pdf

OIE Terrestrial Animal Health Code (reference)

http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.15.4.htm

OIE Terrestrial Manual (reference)

http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/2.08.09_SVD.pdf

Socio-economic impact

Zoonosis: Impact on affected individuals and/or aggregated DALY figures

Not applicable

Zoonosis: cost of treatment and control of the disease in humans

Not applicable

Direct impact (a) on production

Nowadays the impact of SVD is low, mobility is low and mortality nil.

Direct impact (b) cost of private and public control measures

SVD does not cause severe production losses but it is of major economic importance since surveillance, control and eradication measures are costly.

Indirect impact

Countries which are known to have the disease face embargoes on the export of pigs and by products. Several months of interruption of activity in herds affected by SVD outbreaks.

Trade implications

Impact on international trade/exports from the EU due to existing regulations

Outbreaks result in embargo on the export of pigs and pork products.

GAP: due to the pathogenesis of SVD, the risk of virus being present in muscle meat is considered to be low (short viraemic period, no replication of virus in the muscles).

Impact on EU intra-community trade due to existing EU regulations

In case of an SVD outbreak quarantine measures and movements standstill are applied in the affected area.

GAP: the control measures foreseen in case of SVD seem disproportionate.

Impact on national trade due to existing regulations

In case of an SVD outbreak quarantine measures and movements standstill are applied in the affected area.

Main perceived obstacles for effective prevention and control

Difficulties in clinical diagnosis due to the often undisclosed course of the disease, import form countries where the SVD status is not regularly assessed.

GAP: the disease was included among the List A for the clinical similarity to FMD. At present SVD is often unapparent.

Main perceived facilitators for effective prevention and control

Fast and robust diagnostic tools. Surveillance methodologies and appropriate tests to detect unapparent infection.

In case SVD occurs clinically, diagnostic tests are available to differentiate SVD and FMD

Risk

The risks are associated with the movement of pigs or contaminated materials and transport means from countries where the disease is not diagnosed due either to inadequate surveillance systems or to sub clinical occurrence.

Main critical gaps

Conclusion

The main importance of SVD is that it is clinically indistinguishable from FMD, and any outbreaks of vesicular disease in pigs must be assumed to be FMD until investigated by laboratory tests and proven otherwise. However, subclinical infection has been the most frequent condition observed during recent years.

Sources of information

Name of expert group leader

Emiliana Brocchi - Istituto Zooprofilattico Sperimentale della Lombardia e dell Emilia Romagna (IZSLER)

Name of reviewers

Project Management Board

Date of preliminary approval

17th September 2010

Date of final approval

1st October 2010