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Title: Dengue vaccine trial guidelines and role of large-scale, post proof-of-concept demonstration projects in bringing a dengue vaccine to use in dengue endemic areas
Authors: G. William Letson
Pratap Singhasivanon
Eduardo Fernandez
Nihal Abeysinghe
Juan Jose Amador
Harold S. Margolis
Robert Edelman
International Vaccine Institute, Seoul
Mahidol University
Brock University
Ministry of Health Sri Lanka
Program for Appropriate Technology in Health (PATH)
University of Maryland School of Medicine
Keywords: Immunology and Microbiology;Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Jan-2010
Citation: Human Vaccines. Vol.6, No.10 (2010), 802-809
Abstract: In 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.
ISSN: 15548619
Appears in Collections:Scopus 2006-2010

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