Research and Development, Sanofi Pasteur, 69007 Lyon, France; email:
Annu Rev Med. 2016;67:387-404. doi: 10.1146/annurev-med-091014-090848. Epub 2015 Oct 23.
Dengue is a growing threat worldwide, and the development of a vaccine is a public health priority. The completion of the active phase of two pivotal efficacy studies conducted in Asia and Latin America by Sanofi Pasteur has constituted an important step. Several other approaches are under development, and whichever technology is used, vaccine developers face several challenges linked to the particular nature and etiology of dengue disease. We start our review by defining questions and potential issues linked to dengue pathology and presenting the main types of vaccine approaches that have explored these questions; some of these candidates are in a late stage of clinical development. In the second part of the review, we focus on the Sanofi Pasteur dengue vaccine candidate, describing the steps from research to phase III efficacy studies. Finally, we discuss what could be the next steps, before and after vaccine introduction, to ensure that the vaccine will provide the best benefit with an acceptable safety profile to the identified target populations.
登革热是全球日益严重的威胁，开发疫苗是公共卫生的当务之急。赛诺菲巴斯德在亚洲和拉丁美洲完成了两项关键功效研究的积极阶段，这是重要的一步。还有其他几种方法正在开发中，无论使用哪种技术，疫苗开发商都面临着与登革热疾病的特殊性质和病因相关的几个挑战。我们通过定义与登革热病理学相关的问题和潜在问题开始我们的审查，并介绍了探索这些问题的主要疫苗方法类型；其中一些候选者处于临床开发的后期阶段。在审查的第二部分，我们专注于赛诺菲巴斯德的登革热疫苗候选者，描述了从研究到 III 期功效研究的步骤。最后，我们讨论了在疫苗推出之前和之后可以采取的下一步措施，以确保疫苗为确定的目标人群提供最佳的益处和可接受的安全性。
