Guy Bruno, Noriega Fernando, Ochiai R Leon, L'azou Maïna, Delore Valentine, Skipetrova Anna, Verdier François, Coudeville Laurent, Savarino Stephen, Jackson Nicholas
a Research & Development , Sanofi Pasteur , Lyon , France.
b Research & Development , Sanofi Pasteur , Swiftwater , USA.
Expert Rev Vaccines. 2017 Jul;16(7):1-13. doi: 10.1080/14760584.2017.1335201. Epub 2017 Jun 7.
Dengue is an important and still growing public health problem associated with substantial morbidity, as well as significant social and economic impact. The present review describes the main features and development of the first dengue vaccine (CYD-TDV, Dengvaxia®), which has been licensed by several dengue-endemic countries in Asia and Latin America for use in populations above 9 years of age. Areas covered: The review focuses on the large clinical development of CYD-TDV, which includes in particular two pivotal phase III efficacy trials conducted in Asia and Latin America and supported vaccine licensure. Based on these clinical data, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommended considering introduction of the vaccine in geographic settings (national or subnational) with high burden of disease. Long-term safety follow-up studies of the efficacy trials are currently ongoing, and post-licensure studies will evaluate the vaccine effectiveness and safety in 'real-life' following vaccine introduction. Expert commentary: During vaccine development, a number of complexities were tackled, innovation pursued, and risk managed. These aspects, as well as the potential impact of CYD-TDV on public health are also discussed.
登革热是一个重要且仍在不断发展的公共卫生问题，它会引发大量发病情况，还会造成重大的社会和经济影响。本综述描述了首款登革热疫苗（CYD-TDV，登革佳维®）的主要特征及研发情况，该疫苗已获亚洲和拉丁美洲的几个登革热流行国家批准，用于9岁以上人群。涵盖领域：本综述聚焦于CYD-TDV的大规模临床研发，尤其包括在亚洲和拉丁美洲开展的两项关键III期疗效试验，这些试验为疫苗获批提供了支持。基于这些临床数据，世界卫生组织免疫战略咨询专家组（SAGE）建议考虑在疾病负担高的地理区域（国家或国家以下层面）引入该疫苗。疗效试验的长期安全性随访研究目前正在进行，上市后研究将评估疫苗在引入后的“实际应用”中的有效性和安全性。专家评论：在疫苗研发过程中，解决了诸多复杂问题，进行了创新，并对风险进行了管理。本文还讨论了这些方面以及CYD-TDV对公共卫生的潜在影响。
