Individual Consultant in Vaccines and Biologics, American Fork, UT 84003, USA.
Vaccine. 2010 Dec 6;28(52):8246-55. doi: 10.1016/j.vaccine.2010.10.043. Epub 2010 Oct 29.
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.
2009 年 5 月，一组国际登革热专家、疫苗质量和临床评估专家聚集在一起，（i）审查疾病、疫苗研发管道、制造中的质量问题、环境风险评估问题、新型重组登革热活疫苗的非临床和临床评估，以及（ii）启动修订候选四价登革热疫苗（活）的生产和质量控制世界卫生组织指南。本报告总结了与候选登革热疫苗的质量、安全性和有效性相关的科学和技术问题的意见交流。鉴于新型登革热疫苗是临床研发管道中的主要疫苗，工作组同意（i）在修订世界卫生组织指南时重点关注新型登革热疫苗，以及（ii）在修订中增加新的关于新型登革热活疫苗的非临床和临床评估以及环境风险评估的指南。
