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    Clinical endpoints for efficacy studies

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    Author
    Porter, Chad K.
    Gutierrez, Ramiro L.
    Kotloff, Karen L.
    Date
    2019-01-01
    Journal
    Vaccine
    Publisher
    Elsevier Ltd.
    Type
    Article
    
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    See at
    https://www.doi.org/10.1016/j.vaccine.2019.03.051
    Abstract
    Well-established, validated and clinically meaningful primary and secondary endpoints are critical inadvancing vaccines through proof of principal studies, licensure and pre-qualification. To that end, the field of vaccine development for Shigella, enterotoxigenic Escherichia coli (ETEC) as well as other enteric pathogens would benefit greatly from a focused review of clinical endpoints and the use of common end-points across the field to enable study-to-study comparisons as well as comparative assessments between vaccine candidates. A workshop was conducted to review clinical endpoints from controlled human challenge studies, field studies in naïve adult travelers and pediatric studies in low-middle income countries and to develop a consensus on clinical endpoints for future vaccine trials. Following sequential presentations on different study designs (CHIM, travelers’ efficacy and pediatric efficacy), workshop participants broke into three simultaneous workgroups focused on those study designs to discuss a number of topics key to clinical endpoints specific to each study design. Previously utilized endpoints were reviewed with an eye towards potentially novel endpoints for future studies and consideration of the disease parameters and spectrum of disease targeted for prevention. The strength of support among workshop participants for the use of various endpoints is summarized as are recommendations for additional endpoints to be considered in future studies. It is anticipated that this report will facilitate endpoint determination in future efficacy trials of vaccine candidates.
    Keyword
    CHIM
    Controlled human infection model
    Diarrheal diseases
    Efficacy
    Endpoints
    Enterotoxigenic E. coli
    ETEC
    Shigella
    Travelers' diarrhea
    Vaccine
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064067946&origin=inward; http://hdl.handle.net/10713/10082
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.vaccine.2019.03.051
    Scopus Count
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    UMB Open Access Articles 2019

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