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Title: | A human model of Buruli ulcer: Provisional protocol for a Mycobacterium ulcerans controlled human infection study. | Austin 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 | Affiliation: | Department of Microbiology and Immunology, Doherty Institute, University of Melbourne, Melbourne, Victoria, 3000, Australia.;Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia.;Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.;Department of General Medicine, The Royal Melbourne Hospital, Parkville, Victoria, Australia. Department of Infectious Diseases, Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia.;Department of Infectious Diseases, Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.;Department of Infectious Diseases, Barwon Health, Geelong, Victoria, Australia. Department of Microbiology and Immunology, Doherty Institute, University of Melbourne, Melbourne, Victoria, 3000, Australia.;Austin Health, Heidelberg, Victoria, Australia. Department of Dermatology, The Royal Melbourne Hospital, Parkville, Victoria, Australia. Department of Plastic and Reconstructive Surgery, The Royal Melbourne Hospital, Parkville, Victoria, Australia. Department of Microbiology and Immunology, Doherty Institute, University of Melbourne, Melbourne, Victoria, 3000, Australia. Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.;Department of Medical Biology, University of Melbourne, Parkville, Victoria, Australia. Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia.;Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.;Department of Infectious Diseases, Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia. Department of General Medicine, The Royal Melbourne Hospital, Parkville, Victoria, Australia.;WHO Collaborating Centre for Bioethics, Monash University, Clayton, Victoria, Australia. Tropical Diseases Research Group, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.;Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia.;Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia. Department of Microbiology and Immunology, Doherty Institute, University of Melbourne, Melbourne, Victoria, 3000, Australia.;WHO Collaborating Centre for Mycobacterium ulcerans, Doherty Institute, Melbourne, Victoria, Australia. The Peter Doherty Institute |
Issue Date: | 2024 | Date: | 2024 | Publication information: | Wellcome Open Research 2024; 9 | 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. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/35540 | DOI: | 10.12688/wellcomeopenres.22719.1 | ORCID: | 0000-0001-9873-7163 0000-0001-5750-1920 0000-0001-5540-8124 0000-0001-6596-9718 0000-0001-5940-602X 0000-0002-9432-6700 0000-0003-0150-123X |
Journal: | Wellcome Open Research | Start page: | 488 | PubMed URL: | 39386965 | Type: | Journal Article | Subjects: | Bairnsdale ulcer Buruli ulcer M. ulcerans Mycobacterium ulcerans controlled human infection model |
Appears in Collections: | Journal articles |
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