@article{ce8fafa6b0a74ca8b2416d4304e23ce9,
title = "WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11-12 May 2009",
abstract = "In May 2009, a group of international experts on dengue, vaccine quality and clinical evaluation met together (i) to review disease, vaccine pipeline, quality issues in manufacturing, issues of environmental risk assessment, nonclinical and clinical evaluation of live recombinant dengue vaccines and (ii) to initiate revising WHO guidelines for the production and quality control of candidate tetravalent dengue vaccines (live). This report summarizes an exchange of views on scientific and technical issues related to the quality, safety and efficacy of candidate dengue vaccines. Recognizing live dengue vaccines are the major vaccines in the clinical pipeline, the Working Group agreed (i) to focus on live dengue vaccines in the revision of the WHO guidelines and (ii) to add new guidelines on nonclinical and clinical evaluation, and environmental risk assessment for live dengue vaccines in the revision.",
keywords = "Dengue vaccines, Evaluation, Standards, World Health Organization",
author = "Dennis Trent and Jinho Shin and Joachim Hombach and Ivana Knezevic and Philip Minor",
note = "Funding Information: Dr. R. Edelman (University of Maryland, USA) reviewed the 2008 revision of WHO Guidelines for Clinical Evaluation of Dengue Vaccines in Endemic Areas (IVB/08.12) [25,26] . DENV is spreading rapidly through the world where A. aegypti is the principal vector. Basic and clinical research has received increased financial support from industry, WHO, government and the Pediatric Dengue Vaccine Initiative (PDVI). Under this support significant strides have been made in understanding the biology of dengue disease, vector competency and immunology of the protective immune response. Many candidate vaccines are in preclinical development and three attenuated vaccines are in Phase I/II clinical trials. The 2008 revision has provided detailed guidance on establishing clinical end points, immune correlates of protection, and the impact of previous flavivirus infection and vaccination against other flaviviruses on immunization for dengue. The guidelines outline Phase II and III bridging studies with considerations for Phase III and IV (post-licensure trials). Successful vaccination against dengue must provide protection against disease from all 4 serotypes simultaneously and evaluate the role of neutralizing antibody in protection. It is critical that long-term vaccine safety and protection efficacy of a vaccine be evaluated in areas that are endemic for flavivirus infection and that clinical follow-up of vaccine volunteers is extended for 3–5 years post immunization. ",
year = "2010",
month = dec,
day = "6",
doi = "10.1016/j.vaccine.2010.10.043",
language = "English (US)",
volume = "28",
pages = "8246--8255",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "52",
}