A human model of Buruli ulcer: Provisional protocol for a Mycobacterium ulcerans controlled human infection study. [version 2; peer review: 1 approved, 2 approved with reservations]

Abstract

Critical knowledge gaps have impeded progress towards reducing the global burden of disease due to Mycobacterium ulcerans, 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 M. ulcerans 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.

Keywords

• Buruli ulcer
• Bairnsdale ulcer
• Mycobacterium ulcerans
• M. ulcerans
• controlled human infection model
• eng