Publication: 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
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Issued Date
2010-01-01
Resource Type
ISSN
15548619
15548600
15548600
Other identifier(s)
2-s2.0-78649349711
Rights
Mahidol University
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SCOPUS
Bibliographic Citation
Human Vaccines. Vol.6, No.10 (2010), 802-809
Suggested Citation
G. William Letson, Pratap Singhasivanon, Eduardo Fernandez, Nihal Abeysinghe, Juan Jose Amador, Harold S. Margolis, Robert Edelman 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. Human Vaccines. Vol.6, No.10 (2010), 802-809. doi:10.4161/hv.6.10.13018 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/29296
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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
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.