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dc.contributor.authorG. William Letsonen_US
dc.contributor.authorPratap Singhasivanonen_US
dc.contributor.authorEduardo Fernandezen_US
dc.contributor.authorNihal Abeysingheen_US
dc.contributor.authorJuan Jose Amadoren_US
dc.contributor.authorHarold S. Margolisen_US
dc.contributor.authorRobert Edelmanen_US
dc.contributor.otherInternational Vaccine Institute, Seoulen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherBrock Universityen_US
dc.contributor.otherMinistry of Health Sri Lankaen_US
dc.contributor.otherProgram for Appropriate Technology in Health (PATH)en_US
dc.contributor.otherUniversity of Maryland School of Medicineen_US
dc.identifier.citationHuman Vaccines. Vol.6, No.10 (2010), 802-809en_US
dc.description.abstractIn this review, we consider the issues impacting conduct and design of dengue vaccine trials with reference to the recently published World Health Organization "Guidelines for Conduct of Clinical Trials of Dengue Vaccines in Endemic Areas." We discuss logistic, scientific and ethical challenges concerning evaluation and introduction of dengue vaccines; these range from randomized trials that establish "proof of concept" of vaccine efficacy, to post-"proof of concept" trials, particularly demonstration projects likely to be required for licensure or for the introduction of an already licensed vaccine into public use. We clarify and define the meaning of "proof of concept" in the clinical trial context and the meaning of terms "phase 2b", "phase 3b" and "demonstration project", which are commonly used but have not been defined well in the clinical literature. © 2010 Landes Bioscience.en_US
dc.rightsMahidol Universityen_US
dc.subjectImmunology and Microbiologyen_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titleDengue vaccine trial guidelines and role of large-scale, post proof-of-concept demonstration projects in bringing a dengue vaccine to use in dengue endemic areasen_US
Appears in Collections:Scopus 2006-2010

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