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

• Published in: Wellcome open research Vol. 9; p. 488
• Main Authors: Muhi, Stephen, Marshall, Julia L., O'Brien, Daniel P., Johnson, Paul D.R., Ross, Gayle, Ramakrishnan, Anand, Mackay, Laura K., Doerflinger, Marcel, McCarthy, James S., Jamrozik, Euzebiusz, Osowicki, Joshua, Stinear, Timothy P.
• Format: Journal Article
• Language: English
• Published: London, UK F1000 Research Limited 2024; Wellcome
• Subjects: Bairnsdale ulcer; Buruli ulcer; controlled human infection model; eng; M. ulcerans; Mycobacterium ulcerans; Study Protocol
• ISSN: 2398-502X; 2398-502X
• DOI: 10.12688/wellcomeopenres.22719.1

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.