Mycoplasma Bovis - available

Control ToolsDisease details
Sources of informationRisks
ConclusionScore criteria
Prioritisation ModelGap Analysis

Control Tools

Diagnostics availability

Commercial diagnostic kits available worldwide

Some commercial ELISA tests are available.

GAP: BioX produce ELISA kits for antigen and antibody detection. The sensitivity and specificity of these and other kits is not known, but questionable.

Commercial diagnostic kits available in Europe

Some commercial ELISA tests are available.

Diagnostic kits validated by International, European or National Standards

None.

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

Not included in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial animals.

Commercial potential for diagnostic kits in Europe

Potential exists with the need to identify whether Mycoplasma bovis is a primary or secondary causal agent associated with production problems.

GAPS: Considerable potential for the development of more specific and sensitive tests, ideally rapid with the possibility of pen-side application. Multiplexed testing for different organisms and activity associated with disease could be developed.

DIVA tests required and/or available

None, but would be helpful if effective vaccines are developed. Should be linked to the vaccine development.

Opportunities for new developments

Comments NA

Vaccines availability

Commercial vaccines availability (globally)

Commercially available vaccines are licensed in the USA. These are Bacterin type vaccines with a number licensed for prevention of respiratory disease and others for the prevention of mastitis.

GAPS:

  • Autogenous vaccine used successfully on a few farms in the UK.
  • The contribution of the immune response to the development of chronic lesions indicates caution in the use of vaccines. The mechanism of disease development needs to be understood to develop safe and effective vaccines for worldwide use.

Commercial vaccines authorised in Europe

No commercial vaccines exist for Mycoplasma bovis.

Marker vaccines available worldwide

None.

Marker vaccines authorised in Europe

None.

Effectiveness of vaccines / Main shortcomings of current vaccines

Not applicable.

Commercial potential for vaccines in Europe

High provided demand and price are satisfactory.

Regulatory and/or policy challenges to approval

Use of genetically modified vaccines might be problematic in some countries. The field trials may need specific regulation regarding the release of GMOs into the environment.

Commercial feasibility (e.g manufacturing)

Feasible.

Opportunity for barrier protection

Could be used to protect farms in regions or zones provided that the vaccinated animals do not excrete the organism.

Opportunity for new developments

Genomic analysis and anticipated expansion to various species differing in clinical properties will aid the identification of species consensus target genes.

While there are several research groups worldwide that have both interest and expertise to work on vaccine development, it has been impossible to get proper funding for this topic in the past decade. The apparent disregard by funding organisations of mycoplasma-associated diseases is not due to insufficient evidence showing the economic importance, but rather a consequence of the generally low profile of these pathogens in the decision-making bodies.

GAPS: need to develop and market vaccines. They should be safe and effective against all clinical signs, at all stages of animal production, against all M. bovis variations, stable, ideally single shot, provide long-term effective protective immunity and be usable in all countries. DIVA would be beneficial.

Pharmaceutical availability

Current therapy (curative and preventive)

There is a poor response to treatments especially in cases of chronic respiratory disease or mastitis. The US Food and Drug administration have approved the only antibiotic for the treatment of bovine respiratory disease linked to Mycoplasma bovis. This is DRAXXIN (tulathromycin) an injectable solution produced by Pfizer Animal Health. A range of other antibiotics are used against Mycoplasma bovis infection but high levels of resistance are seen with a number of the antibiotics.

GAPS: Lack of an understanding of the epidemiology of the disease at the herd level hampers the development of therapeutic preventive measures. Currently the most widely used preventive measure is chemotherapy but test and slaughter is a crude and less economical strategy to control this disease.

Future therapy

Effective anti-mycoplasma drugs.

Commercial potential for pharmaceuticals in Europe

High potential for an effective anti mycoplasma drug but there could be constraints in relation to potential resistance if the antibiotic is applied widely.

Regulatory and/or policy challenges to approval

None foreseen.

Commercial feasibility (e.g manufacturing)

Commercially feasible but would depend on the market, price and demand.

Opportunities for new developments

Genomic analysis and anticipated expansion to various species differing in clinical properties will aid the identification of species consensus target genes.

Identification of the drug exporter ABC transporters in the M. bovis PG45 genome. Such proteins may be involved in the export of antibiotics and they are potential targets for development of new antimicrobial agents.

GAPS: Effective antibiotic treatment regimes need investigating, especially with the widespread occurrence of resistance. Development of new or alternative antibiotics is required. Consideration could be given to assessing the effectiveness of medicinal plants.

New developments for diagnostic tests

Requirements for diagnostics development

  • Diagnostics should be standardized, fast and cheap.
  • Comparison and evaluation of existing diagnostic tests on a pan-European scale is required but has not been conducted so far.
  • Commercial availability of more serological tests and their validation.
  • Development of rapid "field" test to identified infected cattle.
  • Development of rapid molecular assays for detection of resistant strains in the clinical samples.

GAPS:

  • Herd positive and negative samples are usually readily obtainable. One potential problem is the different disease manifestations and interpretation of ‘healthy’ carrier animals and if the presence of the organism is an effective indicator of disease in the herd/group of animals.
  • Intermittent shedding of organisms can give rise to ‘false’ antigen negative animals.
  • Testing at individual animal level rather than herd level may be beneficial.
  • While there are several research groups worldwide that have both interest and expertise to work on diagnostic development, it has been impossible to get proper funding for this topic in the past decade.

Time to develop new or improved diagnostics

In general the development of tests is much faster and less expensive than developing vaccines. From development through validation to commercial availability will be time consuming and can take years.

Cost of developing new or improved diagnostics and their validation

The development and validation of new tests is time consuming and labour intensive which is costly. Costs cannot be specified as they will depend on the nature of the test and the cost of producing reagents and supplying reading or processing machines if necessary. Once validated there will need to be a commercial company willing to market the test.

Research requirements for new or improved diagnostics

  • Increased knowledge on pathogenesis and involved virulence factors.
  • Increased knowledge on host immune response.
  • Increased knowledge on ability of M. bovis to invade host cells.
  • Extended sequencing of field strains from different clinical conditions.

GAPS: Most technologies are available to develop the required new diagnostics, however the main issue is investment in the small number of workgroups working on these fastidious and specialist organism. Limited investment in none-zoonotic and endemic diseases has restricted development of new improved diagnostics.

Improved diagnostic tests required either to be developed or evaluated and implemented:

  • Molecular eg.: R-T PCR, LAMP; micro-array
  • Serological eg. : ELISA, Latex agglutination tests, lateral flow devices, resonance devices, etc.
  • Culture: Rapid systems, with species isolation and identification methods.
  • Methods for diagnosis should include antibiotic sensitivity testing.
  • Penside tests (serological and antigen detection)
  • Molecular epidemiological tests have been developed to differentiate isolates, but a universal “typing scheme” has not been developed or “types” related to pathogenicity/clinical signs.
  • Multiplex testing for BRD organisms and mastitis organism to include M. bovis.

Technology to determine virus freedom in animals

Would need effective mechanisms to determine freedom from infection with Mycoplasma bovis using a mixture of culture, PCR and serology.

New developments for vaccines

Requirements for vaccines development / main characteristics for improved vaccines

  • Increase knowledge on host immune response.
  • Requirements for safer, immunogenic vaccine that in ideal case will be able to protect from infection with field isolate.
  • Some success has been reported using a saponised autogenous vaccine in the UK, but more funding for research projects is required to address this issue adequately.

GAPS: Vaccine development is required. Some success has been reported using a saponised autogenous vaccine in the UK. EMIDA project will examine this vaccine more widely. Some other vaccine development has resulted in exacerbation of disease. Other concerns relate to the variability of the surface proteins expressed by M. bovis and the possible requirement to use multiple strains in a vaccine. Adjuvant selection could be critical is stimulating a protective immune response.

Time to develop new or improved vaccines

Depending on when a candidate vaccine could be identified the timescale will be 5-10 years. This will involve development, clinical trials and licensing. Potential vaccines need to be identified and subjected to initial trials and depending on the outcome will depend the time to commercial availability.

Cost of developing new or improved vaccines and their validation

Expensive with the need to develop and undertake all the relevant tests to provide data to enable the product to be authorised. Field trial will be difficult as will evaluating the results.

Research requirements for new or improved vaccines

  • Increase knowledge on host immune response.
  • Identification of protective antigens, which may be used as a vaccine candidates, through genomic, bioinformatics, proteomic, immunological and biological approaches.

GAPS: Improved understanding of the disease pathogenicity and infectious routes along with a good understanding of the host’s immunological response would provide a sound basis for antigen and adjuvant selection.

In addition a good reproducible model for disease is also essential, especially as the infection can result in varied clinical signs such as calf pneumonia, arthritis, mastitis, etc. Evaluation of potential vaccines against these clinical signs will be required.

New developments for pharmaceuticals

Requirements for pharmaceuticals development

GAPS:

  • Screening of novel chemicals and plant extracts is required to develop new pharmaceuticals. Proper regard will need to be given to meat and milk withdrawal times for newly developed pharmaceuticals.
  • Decoding molecular mechanisms responsible for antibiotic resistance.

Time to develop new or improved pharmaceuticals

Time to develop would depend on the product and the trials necessary to validate the efficacy and safety. Commercial production would then take further time. 5 to 10 years seems a realistic timeframe.

Cost of developing new or improved pharmaceuticals and their validation

Expensive but difficult to assess as it will depend on the product and the trials necessary to validate and license.

Research requirements for new or improved pharmaceuticals

  • Standardization of MIC tests.
  • Determination of MIC breakpoints for Mycoplasma bovis.
  • Decoding mechanisms responsible for antibiotic resistance.
  • Identification of relevant protective antigens, through genomic, bioinformatic, proteomic, immunological and biological approaches.

GAPS: Rapid and improved minimum inhibition concentration and mycoplasmacidal tests need developing and standardising. Breakpoint values need to be determined to relate in vitro tests to in vivo situations. These tests should take into account the possible impact of biofilm formation. The development of resistance and mechanisms of resistance will also need investigating.

Disease details

Description and characteristics.

Pathogen

Mycoplasma bovis is a member of the genus Mycoplasma and Family Mycoplasmataceae within the Class Mollicutes. Mycoplasma bovis was first detected as a cause of bovine mastitis in the USA in the 1960s and has since been detected in most countries worldwide with only a few exceptions.

Variability of the disease

Mycoplasma bovis is considered to be one of the more pathogenic species of Mycoplasma and is an important pathogen of cattle.

GAPS:

  • Mycoplasma bovis disease makes a significant economic impact on cattle rearing, but its importance has not yet been recognised sufficiently to be listed by The World Organisation for Animal Health (OIE).
  • The role of variable surface proteins is not currently understood.
  • The recent publication of one genome of the M. bovis type strain (GenBank accession no. CP002188) showed the enormous potential variation the organism has (Wise et al., 2011).
  • More genome sequences of isolates from hosts with different clinical signs could increase our knowledge of the organism’s mechanisms for survival and its evasion of the host defence mechanisms.

Stability of the agent/pathogen in the environment

Mycoplasma bovis can survive outside the host in the environment especially if protected from sunlight. At lower temperatures it can survive for days or weeks in water, manure etc.

GAPS: Mycoplasmas lack a cell wall that should make them susceptible to environmental pressures, however they do survive for long periods, with one report (Justice-Allen et al., 2010) indicating survival in bedding sand for 8 months. Recent research has partly explained extended survival through the presence of biofilms, however further work is required.

Species involved

Animal infected/carrier/disease

Infected cattle can become asymptomatic carriers and may shed the organism through nasal discharges or in milk for months to years without showing clinical signs. It is the most frequent Mycoplasma pathogen linked to pneumonia, mastitis, and arthritis in cattle.

GAPS: Other species may become infected, or be carriers – cases have been reported in sheep, goats, buffaloes, deer and chickens. Diagnosis in sheep and goats is complicated by genetic homology of M. bovis with Mycoplasma agalactiae.

Human infected/disease

No evidence for human disease with Mycoplasma bovis.

GAP: A few cases have been reported in immunocompromised patients (Pitcher and Nicholas, 2005).

Vector cyclical/non-cyclical

None.

Reservoir (animal, environmental)

Cattle.

Description of infection & disease in natural hosts

Transmissibility

Highly contagious. Easily transmitted often by the aerosols.

Pathogenic life cycle stages

Not applicable.

Signs/Morbidity

The diseases caused by Mycoplasma. bovis can be very variable. These include mastitis, pneumonia, arthritis and genital disorders which can occur in cattle of all ages. The organism has been associated with polyarthritis in feedlot cattle and otitis media in young calves. Subclinical, clinical or chronic mastitis may be caused by Mycoplasma bovis. Mastitis can be severe with one or all quarters being affected with a serous or purulent exudate. Cows may not show any systemic signs in spite of the udder infection Mycoplasma bovis is a primary cause of calf pneumonia typically in a non specific respiratory disease that does not respond to antibiotics. In pneumonia it is nearly always associated with a range of other pathogens where it may have a synergistic role. As a consequence Mycoplasma. bovis may be overlooked as the causal agent due to the presence of the more familiar pathogens.

GAP: A few isolates have been made from the brain, one of these cases was associated with a large spheroidal fibrinous lesion in the heart.

Incubation period

Variable depending on the age of animals, the clinical and pathological effects of infection. Difficult to define due to difficulty in diagnosis and in assessing the time of infection. Experimentally incubation may be a few days for mastitis and from 7 day for pneumonia. Field cases of pneumonia are probably much longer and influenced by the co-infectants present.

GAP: In one herd outbreak of mycoplasma mastitis the incubation period was estimated to be 13.6 days (Punyapornwithaya et al., 2011). But strain and herd management differences likely impact the length of the incubation period making this a relatively unknown factor in the control of the disease.

Mortality

Variable depending on the clinical disease, age of animals and other infections. Can be high in the case of pneumonia and arthritis.

Shedding kinetic patterns

Infected cattle can shed the organism for months to years.

GAP: Role of the asymptomatic carrier in a herd outbreak is largely unknown.

Mechanism of pathogenicity

Mycoplasma bovis can probably invade tissues and enter the bloodstream to spread to other tissues.

GAPS:

  • Mechanisms of pathogenicity are currently poorly understood for M. bovis.
  • Its transmission within the host, predilection for specific sites, intermittent shedding and differences in resulting clinical signs are not known.
  • The role of some defined virulence factors such as the variable surface proteins in disease is still to be ascertained.
  • Possible differences in route of infection, infectious dose, host susceptibility, age, breed etc also requires investigation.
  • The ability of MB to invade bovine peripheral blood mononuclear cells and erythrocytes has been recently demonstrated by van der Merwe et al., 2010.
  • The invasion of circulating immune cells and erythrocytes could play an important role in pathogenicity of MB disease (protection of the pathogen from host immune response, administered antibiotics and may lead to persistence of infection and dissemination of the pathogen between organ systems).
  • Methods of making M. bovis genetic mutants have been developed, coupling these with studies in animal models is critical to understanding pathogenesis.

Zoonotic potential

Reported incidence in humans

No evidence of transmission to humans.

GAP: A few cases have been reported in immunocompromised patients (Pitcher and Nicholas, 2005).

Estimated level of under-reporting in humans

Not applicable.

GAP: Immunocompromised people with close contact with infected cattle or their products (infected milk or faeces).

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

Not applicable.

GAP: Immunocompromised people with close contact with infected cattle or their products (infected milk or faeces).

Symptoms described in humans

Not applicable.

GAP: Respiratory disease, bronchopneumonia.

Likelihood of spread in humans

Rare.

Impact on animal welfare and biodiversity

Both disease and prevention/control measures related

Serious impact on the welfare of cattle through the disease it causes.

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

No information although a case of infection in buffalo in the USA caused a high mortality.

GAPS: Some farmed species of bison, buffalo and deer have been affected, but spread into wildlife or their potential as hosts has not been investigated. Farmed bison have experienced acute outbreaks with high mortality in adults, and it is not known if this represents high susceptibility of this species or naive status of the herds. Probably low risk for cervids and antelope family of species.

Slaughter necessity according to EU rules or other regions

Culling infected carrier animals especially those with mastitis may be the only method of reducing the infection levels on a farm.

Geographical distribution and spread

Current occurence/distribution

Mycoplasma bovis was first identified in the USA in 1961 and is now considered to be present worldwide. It is the most important Mycoplasma pathogen in cattle in the USA.

Epizootic/endemic- if epidemic frequency of outbreaks

Can spread very rapidly once introduced into a herd. Spread to new herds is usually due to the movement of asymptomatic carriers being purchased and introduced into a clear herd.

GAP: Suspect that stress of cattle (climatic changes, overcrowding, introduction of new animals, and translocation) might trigger an outbreak.

Seasonal cycle (seasonality)

None.

GAPS: Calf pneumonia is undoubtedly higher during colder seasons with M. bovis pneumonia appearing to account for approximatively 20-30% of infections. Temperature fluctuations are more likely to be a key factor in disease and not just exposure to the cold. Poor housing conditions are probably an important contribution to pneumonia in winter conditions. In seasons of reduced pneumonia M. bovis may account for a higher percentage of pneumonic cases.

Speed of spatial spread during an outbreak

Rapid.

GAP: Instances of few seropositive animals within large sero-negative herds requires additional study on epidemiology of transmission.

Transboundary potential of the disease

High association with movement of clinically normal infected animals.

Seasonal cycle linked to climate

No.

Distribution of disease or vector linked to climate

No.

Outbreaks linked to extreme weather

No apart form the impact of adverse weather on the animals.

GAP: Link to sudden changes of weather.

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)

The primary routes of infection can vary depending on the problem in the infected herd but are usually close contact through direct nose to nose transmission via aerosols and/or by the ingestion of infected milk. Milking parlour hygiene for mastitis.

GAP: Arthritis is not necessarily a final result of a bacteraemia, pneumonia and mastitis can result from primary mastitis and pneumonia respectively.

Occasional mode of transmission

Ingestion of contaminated milk is a major source for calves.

Conditions that favour spread

Movement of infected animals into clean herds or vice-versa.

Detection and Immune response to infection

Mechanism of host response

Humoral response.

GAP: Immune response contributes to the lesion development, at least at chronic stage.

Immunological basis of diagnosis

Serological tests for the presence of antibodies.

Main means of prevention, detection and control

Sanitary measures

Mycoplasmas can be introduced in a herd by subclinical infected carriers. Once established in the herd, the infection is difficult to control.

Mechanical and biological control

Limited methods available for control. Control of other pathogens by vaccination to reduce the impact of Mycoplasma bovis as a secondary infection. When Mycoplasma bovis is the primary pathogen it can be difficult to control. Preventing the introduction into the herd by sourcing replacement stock from know free herds, management factors by avoiding mixing cattle of different ages especially calves and culling positive animals. Reducing co-mingling stress can reduce clinical presentations, both for mastitis or respiratory disease.

Diagnostic tools

Isolation and identification of Mycoplasma bovis from bulk milk tank or from cows with clinical mastitis. Use of PCR and the DGGE (denaturing gradient gel electrophoresis) to differentiate the strains of mycoplasma.

Serology using paired sera collected at 10-14 day intervals to detect rising antibody titres. Many different tests have been used including indirect ELISA, indirect haemagglutination etc...

GAPS: Intermittent shedding of organisms and the inhibitors present in milk may reduce the effectiveness of current tests. Other tests such as LAMP, R-T PCR and Micro-array are beginning to be reported but are not in routine use. No pen-side tests are available.

Vaccines

A number of commercial vaccines exist prepared from a limited number of strains.

GAP: Autogenous vaccines are produced by several companies for use solely in the USA. Data about their effectiveness is sparse. Autogenous vaccine is prepared in the UK.

Therapeutics

Mycoplasma bovis as with other organisms in the group lacks a cell wall, which means the organism is resistant to some commonly used antibiotics. In general Mycoplasma bovis is resistant to antibiotic therapy which can also be expensive and ineffective.

Draxxin has recently been approved in the USA for treatment but can be very costly.

GAPS: Several countries have reported antibiotic resistance by Mycoplasma bovis to many antibiotics, including macrolides, tetracyclines, lincosamides, aminocyclitols and fluoroquinolones. Some mechanisms of resistance have been determined as similar to other bacterial species, however some mechanisms have not yet been discovered and require further investigation. Efflux mechanisms are one possible area for investigation.

Biosecurity measures effective as a preventive measure

Limited effect, but a closed herd policy preventing the introduction of M. bovis into a herd is important along with general measures to reduce the levels of infection in the environment. Avoid mixing calves of different age groups. Some recommend distancing dairy farms from calf fattening units.

Border/trade/movement control sufficient for control

No specific controls in place to control movements.

GAP: NZ/Israel impose additional testing on exporting countries.

Prevention tools

Limited availability.

Surveillance

Serosurveillance and disease surveys can be undertaken.

GAPS: The true incidence of M. bovis is not really known, available information appears to be based on passive surveillance information. A serological survey and abattoir survey could give more information about its true prevalence. The real economic cost of the disease has not been determined – a survey to include all cost factors that includes mortality, veterinary costs, treatment, milk loss, added housing/feed costs through lack of weight gain etc would provide useful evidence.

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

This is an organism which has spread widely since it was first identified. Successful measures to control the infection have been very limited. Culling and antibiotic treatments are used to reduce the impact of disease.

The prevalence of mycoplasma disease has been reported to be increasing with a significant positive correlation with increasing herd size.

GAPS: While it is clear the disease has spread by international trade and opening of EU single market, detection is also the result of increased awareness.

Costs of above measures

Expensive. Culling can be devastating and the use of antibiotics is expensive.

GAPS: Reports indicate that early recognition of disease and prolonged therapy is required and consideration should be given of metaphylaxic treatment of whole groups.

Disease information from the OIE

Disease notifiable to the OIE

No.

OIE disease card available

No.

OIE Terrestrial Animal Health Code (reference)

None.

OIE Terrestrial Manual (reference)

None.

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

High with an impact on weight gain, carcase value and mortality as part of the bovine respiratory disease complex. Reduced milk production as a result of clinical and sub clinical mastitis. Overall increased mortality due to a range of clinical conditions. Sterility and abortions may also result from infection.

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

The cost associated with Mycoplasma bovis infection is borne by the private sector. These are related to the treatment, premature culling, mortality and the need to purchase of replacement animals.

Indirect impact

Causes disruption to production.

Trade implications

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

No restrictions on movements.

GAP: No official restrictions on movement within EU, however some countries importing cattle are increasingly aware of the risks of importing infected cattle and are requesting cattle are tested and shown to be free of Mycoplasma bovis.

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

No restrictions on movements.

Impact on national trade due to existing regulations

No restrictions on movements.

Main perceived obstacles for effective prevention and control

  • No effective vaccines available,
  • Insidious infection not always easily diagnosed
  • Difficult to eliminate from a herd
  • Difficult to assess cause of the bovine respiratory disease complex when a number of other pathogens are also involved.
  • Development of antibiotic resistance to many of the antibiotics currently in use.

 

Main perceived facilitators for effective prevention and control

Effective vaccines.

GAPS:

  • Effective vaccines.
  • Reproducible vaccine challenge methods.

Risk

Impact on production.

Conclusion

A major constraint on intensive production affecting intensive beef production particularly in feed lots and milk production in high yielding herds.

Sources of information

Name of expert group leader

Branko Kokotovic - National Veterinary Institute DK (DTU)

Name of reviewers

Project Management Board.

Date of preliminary approval

31st August, 2011.

Date of final approval

30th September, 2011.