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

2024

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

Bairnsdale ulcer

Buruli ulcer

M. ulcerans

Mycobacterium ulcerans

controlled human infection model

Journal Article

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#PLACEHOLDER_PARENT_METADATA_VALUE#

0000-0001-9873-7163

0000-0001-5750-1920

0000-0001-5540-8124

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0000-0001-6596-9718

0000-0001-5940-602X

0000-0002-9432-6700

0000-0003-0150-123X

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.

link

Wellcome Open Research 2024; 9

Wellcome Open Research