Roadmap for development of disease control strategies for bTB

What are we trying to achieve and why? What is the problem we are trying to solve?

The development of a safe, effective vaccine against bTB, reducing R0 to <1 and allowing vaccinated to be differentiated from infected and doesn’t interfere with current diagnostic surveillance.
Development of an effective and safe (including food safety) vaccine for cattle and wildlife.

What are the scientific and technological challenges (knowledge gaps needing to be addressed)?

• The availability of a safe, effective vaccine, acceptable internationally to Regulators, that doesn’t interfere with current cattle statutory diagnostic tests.
• Challenge to obtain Market Authorisation and regulatory approval.
• Challenge to undertake and interpret sufficiently powered safety and efficacy research field trials.
• Challenge to secure ongoing supply of quality-assured vaccine, should field trials support roll out.
• Understanding the immune correlates of vaccine protection, vaccine dose, and timing of booster and testing protocols.

What approaches could/should be taken to address the research question?

See vaccine development roadmap

What else needs to be done before we can solve this need?

Agree and source vaccine candidate, adjuvant and vaccination/booster protocol.
Specify, fund and undertake sufficiently powered, controlled and replicated field studies to establish the safety and efficacy of, for example, BCG vaccine.

Existing knowledge including successes and failures