A human model of Buruli ulcer: Provisional protocol for a Mycobacterium ulcerans controlled human infection study.

<ns3:p>Critical knowledge gaps have impeded progress towards reducing the global burden of disease due to <ns3:italic>Mycobacterium ulcerans</ns3:italic>, the cause of the neglected tropical disease Buruli ulcer (BU). Development of a controlled human infection model of BU has been proposed as an experimental platform to explore host-pathogen interactions and evaluate tools for prevention, diagnosis, and treatment. We have previously introduced the use case for a new human model and identified <ns3:italic>M. ulcerans</ns3:italic> JKD8049 as a suitable challenge strain. Here, we present a provisional protocol for an initial study, for transparent peer review during the earliest stages of protocol development. Following simultaneous scientific peer review and community/stakeholder consultation of this provisional protocol, we aim to present a refined protocol for institutional review board (IRB) evaluation.</ns3:p>