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dc.contributor.authorPorter, Chad K.
dc.contributor.authorGutierrez, Ramiro L.
dc.contributor.authorKotloff, Karen L.
dc.creatorPorter, C.
dc.date.accessioned2019-07-15T19:34:38Z
dc.date.available2019-07-15T19:34:38Z
dc.date.issued2019-01-01
dc.identifier.issn0264410X
dc.identifier.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064067946&origin=inward
dc.identifier.urihttp://hdl.handle.net/10713/10082
dc.description.abstractWell-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.en_US
dc.description.urihttps://www.doi.org/10.1016/j.vaccine.2019.03.051en_US
dc.language.isoen_USen_US
dc.publisherElsevier Ltd.en_US
dc.relation.ispartofVaccineen_US
dc.subjectCHIMen_US
dc.subjectControlled human infection modelen_US
dc.subjectDiarrheal diseasesen_US
dc.subjectEfficacyen_US
dc.subjectEndpointsen_US
dc.subjectEnterotoxigenic E. colien_US
dc.subjectETECen_US
dc.subjectShigellaen_US
dc.subjectTravelers' diarrheaen_US
dc.subjectVaccineen_US
dc.titleClinical endpoints for efficacy studiesen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.vaccine.2019.03.051


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