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]

Muhi, S; Marshall, JL; O&#39;Brien, DP; Johnson, PDR; Ross, G; Ramakrishnan, A; Mackay, LK; Doerflinger, M; McCarthy, JS; Jamrozik, E; Osowicki, J; Stinear, TP

Author(s): Muhi, S; Marshall, JL; O'Brien, DP; Johnson, PDR; Ross, G; Ramakrishnan, A; Mackay, LK; Doerflinger, M; McCarthy, JS; Jamrozik, E; Osowicki, J; Stinear, TP;
Details: Publication Year 2024,Volume 9,Issue #488,Page 10.12688/wellcomeopenres.22719.2
Journal Title: Wellcome Open Research
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.
Publisher: F1000 Research
Research Division(s): Infectious Diseases And Immune Defence
Publisher's Version: https://doi.org/10.12688/wellcomeopenres.22719.2
Open Access at Publisher's Site: https://doi.org/10.12688/wellcomeopenres.22719.2
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-10-25 10:49:24

Last Modified: 2024-10-25 10:49:38