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    Consensus Report on Shigella Controlled Human Infection Model: Conduct of Studies

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    Author
    Talaat, K.R.
    Chen, W.H.
    MacLennan, C.A.
    Kotloff, K.L.
    Date
    2019
    Journal
    Clinical infectious diseases
    Publisher
    Oxford University Press
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1093/cid/ciz892
    Abstract
    Shigella causes morbidity and mortality worldwide, primarily affecting young children living in low-resource settings. It is also of great concern due to increasing antibiotic resistance, and is a priority organism for the World Health Organization. A Shigella vaccine would decrease the morbidity and mortality associated with shigellosis, improve child health, and decrease the need for antibiotics. Controlled human infection models (CHIMs) are useful tools in vaccine evaluation for early up- or down-selection of vaccine candidates and potentially useful in support of licensure. Over time, the methods employed in these models have become more uniform across sites performing CHIM trials, although some differences in conduct persist. In November 2017, a Shigella CHIM workshop was convened in Washington, District of Columbia. Investigators met to discuss multiple aspects of these studies, including study procedures, clinical and immunological endpoints, and shared experiences. This article serves as a uniform procedure by which to conduct Shigella CHIM studies. Copyright The Author(s) 2019.
    Sponsors
    This supplement is sponsored by the Bill & Melinda Gates Foundation.
    Keyword
    Shigella
    challenge studies
    controlled human infection model
    human infection studies
    methods
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85076303359&doi=10.1093%2fcid%2fciz892&partnerID=40&md5=4b46eafc3640abf66abf8326a266840f; http://hdl.handle.net/10713/11536
    ae974a485f413a2113503eed53cd6c53
    10.1093/cid/ciz892
    Scopus Count
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    UMB Open Access Articles 2019

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