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Field trial design to test and validate the performance of the CattleBCG vaccine and associated DIVA diagnostic test in England and Wales - SE3287

Tuberculosis (TB) in cattle is an infectious disease that presents an ongoing challenge to cattle farmers in affected regions e.g. parts of western England and Wales. Development of a cattle vaccine against TB is a high priority for the Department for Environment, Food and Rural Affairs (Defra) and the Welsh government and funding has been made available for a major study of the disease.

The project is to design field trials of a vaccine to protect cattle against TB and of a new cattle TB diagnostic test to show both can be authorised for use in the UK. After authorisation the vaccine and new test could be used in conjunction with other control measures to reduce and hopefully eradicate cattle TB in the UK.

A potential cattle vaccine has been identified following substantial scientific work (initial results suggest it is likely to provide protection to approximately 60% of vaccinated cattle) but its safety and effectiveness in actual field use must be established.

The current test to diagnose TB in cattle unfortunately cannot differentiate between vaccinated cattle and infected cattle, so trials need to be designed to show if a new diagnostic test will work any better under field conditions. The new test must accurately differentiate vaccinated cattle from those naturally infected with TB to help control the disease. Having an effective test is essential for an overall disease control programme.

Prospective designs for field trials will be produced by a team of experts considering how the vaccine and the new diagnostic test could work, and the social and economic implications in the control of this complex disease. Experts in computer modelling, statistical analyses, and conducting field trials to meet regulatory and international trade requirements will work with veterinary practitioners and farmers in TB regions to design the trials.

The objective of this project is to find the most appropriate and cost effective designs for complex field trials in cattle to satisfy both scientific requirements and to address problems to trading and farming caused by the uncertainty in the current TB tests. Subsequent results of field trials will be expected to:

1. support the authorisation of a new cattle TB vaccine by showing its efficacy and safety;
2. validate a new TB diagnostic test;
3. help understand how TB vaccination and testing would be acceptable to farmers, vets, and consumers;
4. assess the likely impact of the vaccine and new test on the UK TB disease situation and the control programme;
5. inform the work, costs and benefits of vaccine deployment in the UK.

TB controls have cost English taxpayers £500 million in the last 10 years, £1 billion is the estimated cost in England over the next decade if no further action is taken. Current control measures cause major difficulties for affected farmers. If well designed field trials are successful in meeting the objectives of the project this will save taxpayers money, support UK farming, and provide a more effective government control strategy leading to TB eradication from British cattle.
The licensing of cattle BCG is a major defra policy priority. This project is to design a field trial that will estimate the efficacy of the vaccine and its associated diagnostics which is required to provide evidence to lift the ban on vaccination throughout the EU.
Project Documents
• FRP - Final Report : SE3287 final report   (2682k)
Time-Scale and Cost
From: 2014

To: 2015

Cost: £206,456
Contractor / Funded Organisations
Triveritas Ltd
Fields of Study
Animal Health