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Since its registration in 2002, Gudair® vaccine has become the key tool for managing paratuberculosis in sheep in Australia. This study was conducted to evaluate its effectiveness in reducing paratuberculosis prevalence in 12 flocks over more than one decade. Flocks with variable initial prevalence (5, 4 and 3 with low, medium, and high prevalence, respectively) were enrolled in the study in 2003-04. Six biennial faecal samplings were conducted in these flocks over a 10year period. At each sampling, faeces from four age groups (3, 4, 5 and 6year-old sheep) were collected from each flock. The aim was to select 7 or 14 pools of faeces constituted with pellets from 50 or 25 sheep from each age group, respectively, but the numbers and sizes of pools did vary due to logistical issues. Samples were cultured using pooled faecal culture approach and sheep level paratuberculosis prevalence was estimated. Changes in probability of a pool being positive and in paratuberculosis prevalence over time were evaluated by fitting generalised-linear and linear mixed models. The proportion of positive faecal pools significantly declined over time from 50.3% at the first sampling in 2003-04 to only 3.1% at the last sampling in 2013-14, suggestive of a 30-fold reduction in the odds of a pooled faecal sample to be positive (p<0.001). Similarly, the average animal level prevalence in flocks dropped from 7.64% at the first sampling to 0.12% at the last sampling. However, faecal shedding persisted and was still present in 3 of the 8 flocks (37.5%) that remained in the study at the last sampling conducted in 2013-14. This is the longest study ever conducted to evaluate paratuberculosis vaccine effectiveness. The results will enable sheep producers to make informed decisions on managing paratuberculosis, and in evaluating the risks of purchasing and trading vaccinated sheep., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Paratuberculosis is a chronic insidious, often serious, disease of the global small ruminant industries, mainly causing losses from mortalities and reduced productivity on-farm, interference in trading and, in Australia, profound socio-economic impacts that have periodically compromised harmony of rural communities. The pathogenesis, diagnosis, impacts and disease management options for ovine and caprine paratuberculosis are reviewed, comparing current controls in the extensive management system for sheep in wool flocks in Australia with the semi-intensive system of dairy flocks/herds in Greece. Improved understanding of the immune and cellular profiles of sheep with varying paratuberculosis outcomes and the recognition of the need for prolonged vaccination and biosecurity is considered of relevance to future control strategies. Paratuberculosis in goats is also of global distribution although the prevalence, economic impact and strategic control options are less well recognized, possibly due to the relatively meagre resources available for goat industry research. Although there have been some recent advances, more work is required on developing control strategies for goats, particularly in dairy situations where there is an important need for validation of improved diagnostic assays and the recognition of the potential impacts for vaccination. For all species, a research priority remains the identification of tests that can detect latent and subclinical infections to enhance removal of future sources of infectious material from flocks/herds and the food chain, plus predict the likely outcomes of animals exposed to the organism at an early age. Improving national paratuberculosis control programs should also be a priority to manage disease risk from trade. The importance of strong leadership and communication, building trust within rural communities confused by the difficulties in managing this insidious disease, reflects the importance of change management considerations for animal health authorities. Although concerns of vaccine efficacy, safety and issues with diagnosis and administration persist, vaccination is increasingly recognized as providing a robust strategy for managing paratuberculosis, having made important contributions to the health of Australian sheep and the lives of producers with affected properties, and offering a mechanism to reduce risk of infection entering the food chain in ovine and caprine products., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Objective: Examine the prevalence of shedding of Mycobacterium avium subsp. paratuberculosis (Mptb) at least 5 years after starting vaccination with Gudair™ in flocks of varying initial prevalence of ovine Johne's disease (OJD) and identify risk factors for variation in vaccine efficacy., Methods: Pooled faecal culture (PFC) was conducted for 41 flocks from southern NSW and Victoria to determine estimates of current OJD prevalence. The data were compared to estimates of prevalence at or prior to commencement of vaccination at least 5 years earlier, based on available serological or PFC tests when vaccination commenced. A cross-sectional study was conducted to identify risk factors for differing prevalence levels in 36 of the flocks., Results: Historical data enabled classification of 37 flocks as high (13; 35.1%), medium (10; 27.0%) or low (14; 37.8%) estimated initial OJD prevalence. Results of PFC in 2008-09 identified that 81.1% (30/37) of flocks had detectable shedders, with 48.6% (18/37) flocks still classified as medium or high OJD prevalence, including 50% (7/14) of flocks initially classified as low prevalence. Shedding was not detected in 18.9% (7/37) flocks. Flocks with OJD prevalence exceeding 1% at 5 years or more following the commencement of vaccination were associated with reports of sheep straying and introduction of new sheep., Conclusion: Despite significant declines in estimated OJD prevalence following vaccination for ≥5 years, 81.1% of flocks were shedding Mptb and considered at risk of spreading the disease or suffering recrudescence of losses if vaccination were to cease. Flock managers are advised to persist with vaccination., (© 2014 Australian Veterinary Association.)

This study was conducted to evaluate the effectiveness of Gudair™ vaccine in decreasing the prevalence of shedding of Mycobacterium avium subsp. paratuberculosis (MAP) in flocks of varying initial prevalence. Thirty-seven self-replacing Merino flocks from New South Wales and Victoria (Australia) that had been vaccinating lambs with Gudair™ for at least five years were enrolled in the study. These flocks had been tested prior to or at commencement of vaccination using pooled faecal culture, agar gel immunodiffusion or both tests. These pre-vaccination test results were used to estimate pre-vaccination prevalence. Post-vaccination prevalence was estimated from culture of usually 7 pools of 50 sheep collected from the enrolled flocks in 2008-2009, approximately five or more years after commencement of vaccination. A Bayesian model was developed to estimate and compare the pre- and post-vaccination prevalences for the enrolled flocks. Apparent pre- and post-vaccination prevalences for flocks were modelled as functions of the true pre- and post-vaccination prevalences, respectively, and the sensitivities and specificities of the respective diagnostic tests. Logit-normal models were specified on pre- and post-vaccination true prevalences and were then used to make inferences about the median and 90th percentile of the prevalence distributions and their differences. Priors were mostly specified based on published literature or analysis of abattoir surveillance data for this population of flocks. The analysis found a significant decline in ovine Johne's disease prevalence from a pre-vaccination median prevalence of 2.72% [95% probability interval (PI): 1.40; 6.86%] to a post-vaccination median prevalence of 0.72% (0.39; 1.27%). However 30 of the 37 flocks still contained sheep that were shedding MAP in their faeces. The results suggest that vaccination with Gudair™ is usually effective in reducing the prevalence of faecal shedding but the response to vaccination is variable among flocks. The Bayesian approach reported here could be implemented in similar situations to compare prevalences where information from multiple diagnostic tests with varied sensitivities and specificities is available., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Calf rearing programs for the control of bovine Johne's disease (BJD) in dairy farms have been widely adopted globally and are based on evidence that the most significant risk factor for developing the disease is exposure of young calves to infectious doses of the causative organism Mycobacterium avium subsp. paratuberculosis (Mptb). Hygienic calf rearing practices aim to break the transmission cycle of Mptb by removing neonatal calves from their dams within 12h of birth and segregating replacement heifers from the herd until they are 12 months of age. But compliance with these interventions is difficult for many producers and delaying the removal of calves from their dams and earlier return of heifers to the herd are common practices. However, would changing these practices increase the risk of animals contracting BJD? Evidence for age susceptibility of calves and young adults to Mptb is reviewed. The experimental studies selected for inclusion in an analysis of the evidence were those designed specifically to address the issue and were confined to examination of 140 cattle in experiments conducted by eight groups of workers between the years 1938 and 2006. Approximately 75% of calves <6 months of age, 50% of those aged between 6 and 12 months, and just less than 20% of cattle >12 months old developed lesions indicative of BJD infection when exposed to any of the tested routes of Mptb infection. No direct evidence was found to support the commonly held view that calf removal from the dam for a maximum period of 12h is preferable to 24h. However the studies did show that if exposure to infection occurs at birth, then the risk of infection progressing to BJD is high, particularly in a highly contaminated environment or if the dam is infected., (Copyright 2009 Elsevier Ltd. All rights reserved.)

Mycobacterium avium subsp. paratuberculosis (Mptb) causes Johne's disease in ruminants. Disease control programmes aim to break the faecal-oral cow-calf transmission cycle through hygienic calf rearing and removal of affected cows from the herd, but these programmes do not take account of the potential for congenital infection. The aims of this study were to critically review research on in utero infection, determine the prevalence of fetal infection in cattle through meta-analysis and estimate the incidence of calves infected via the in utero route. About 9% (95% confidence limits 6-14%) of fetuses from subclinically infected cows and 39% (20-60%) from clinically affected cows were infected with Mptb (P<0.001). These are underestimates for methodological reasons. The estimated incidence of calf infection derived via the in utero route depends on within-herd prevalence and the ratio of sub-clinical to clinical cases among infected cows. Assuming 80:20 for the latter, estimates of incidence were in the range 0.44-1.2 infected calves per 100 cows per annum in herds with within-herd prevalence of 5%, and 3.5-9.3 calves in herds with 40% prevalence. These estimates were not markedly sensitive to the value chosen for the proportion of clinical cases. In utero transmission of Mptb could retard the success of disease control programmes if the opportunities for post natal transmission via colostrum/milk and environmental contamination were able to be controlled. The consequences of fetal infection for the calves so infected are discussed in the context of diagnosis and vaccination together with recommendations for future research.

Objective: To develop an enterprise gross margin (GM) model that predicts the on-farm financial impact of ovine Johne's disease (OJD) for various sheep enterprises in Australia. In addition, to estimate the benefits and costs of control through the use of the Gudair vaccination, including a breakeven point., Design and Population: Data for the model was gained from an observational study conducted over a 3-year period from 2002 to 2004 using sheep from 12 OJD-infected flocks from southern New South Wales. Flocks ranged between 3500 and 20,000 sheep, with owner estimates of 5% or greater OJD mortality at the start of the study., Procedure: A GM model was developed to predict the on-farm financial impact of OJD for various sheep enterprises in Australia, comparing non-infected, infected (status quo) and infected (vaccination) disease scenarios., Results: Vaccination breakeven points are achieved within 2 to 3 years for breeding enterprises if OJD mortalities are high, rising towards 7 years for a Merino ewe enterprise if OJD mortalities are low., Conclusion: The GM model demonstrates the returns to investment of vaccination for Australian sheep producers with OJD-infected flocks.

Objective: To determine i) the prevalence of lesions at the site of vaccination with Gudair, and ii) the incidence of discounting of slaughtered sheep carcasses due to the presence of these lesions., Design: A survey of the prevalence of injection lesions and actual discounts applied to 20 consignments of vaccinates slaughtered in abattoirs in New South Wales., Procedure: Consignments of sheep previously vaccinated against ovine Johne's disease (OJD) were assessed on the slaughter chain for the prevalence of vaccination site lesions and any costs associated with carcass trimming were estimated. In addition a telephone survey was conducted to determine the experiences and risk attitudes of 8 abattoirs in south east New South Wales likely to have previously processed vaccinates., Results: The prevalence of lesions observed was 18% for adult (mutton) and 65% for lamb carcasses. The value of the trim removed was insignificant, the labour cost of its removal was nil and no carcass was downgraded to a lower value grade., Conclusion: Under the market conditions existing at the time the study was conducted, in sheep vaccinated at the recommended site high on the neck, it is unlikely that OJD vaccination site lesions will be a significant cost to producers or the processing industry and will represent only a very small proportion of the total cost of OJD control by vaccination.

Objective: To measure the biological and financial impact of ovine Johne's disease (OJD) mortalities on 12 infected flocks within the endemic area of southern New South Wales over a 3-year period., Design and Population: An observational study was conducted over a 3-year period from 2002 to 2004 on sheep from 12 OJD-infected flocks from southern NSW. Flocks ranged from between 3,500 and 20,000 sheep. At the start of the study owner estimates of OJD mortality were 5% or greater., Method: Annual mortality rates were estimated from farm records provided by owners. The proportion of OJD mortalities was assessed after histological examination of tissues collected from dead and moribund sheep during 5-day necropsy inspections conducted in autumn, winter, spring and summer in 2002. The financial impact was estimated using a gross margin analysis for each of the three study years and by placing a financial value on the necropsied sheep., Results: On the 12 farms, the average OJD mortality rate was 6.2% (range 2.1% to 17.5%) in 2002, 7.8% (range 1.8% to 14.6%) in 2003 and 6.4% (range 2% to 11.9%) in 2004. The average decrease in gross margin due to OJD infection on a farm in 2002 was 6.4% (range 2.2% to 15.4%), 8.5% (range 3.1% to 15.8%) in 2003 and 7.4% (range 1.5% to 15.4%) in 2004. This equates to an average reduction in annual income of $13,715 per farm per year. OJD losses accounted on average for two thirds of the total estimated financial loss associated with sheep deaths., Conclusion: This study demonstrates the significant biological and financial impact of OJD on sheep flocks. These findings are of relevance to all Australian sheep flocks infected or at risk of OJD infection.