Fire Department/Rio de Janeiro State and Professor of medicine at Unigranrio, NATS - Rua das Laranjeiras 374/ 5° andar CEP 22240-004, Rio de Janeiro, RJ, Brazil.
Biostatistics and Modelling/ Instituto Nacional de Cardiologia, Rio de Janeiro, RJ, Brazil.
BMC Infect Dis. 2019 Aug 28;19(1):750. doi: 10.1186/s12879-019-4369-5.
Dengue is an arbovirus that has rapidly spread worldwide, and the incidence of dengue has greatly increased in recent decades. The actual numbers of dengue cases are underreported, and many cases are not classified correctly. Recent estimates indicate that 390 million dengue infections occur per year (95% CI, 284-528 million), of which 96 million (67-136 million) are symptomatic infections of any severity. One of the goals of the World Health Organization is to reduce dengue mortality by 50% by the year 2020. The use of a vaccine can be an important strategy to achieve this goal. Vaccines for dengue are in various stages of development; in Brazil, only one commercial formulation is available (CYD-TDV), which was developed by Sanofi Pasteur.
To evaluate the efficacy of Dengue vaccine, a systematic review with a meta-analysis was conducted using randomized controlled clinical trials published between 2000 and 2017 that were identified in the MEDLINE databases via PubMed, LILACS, Cochrane Library, and EMBASE. The selection was performed by two reviewers independently, with disagreements resolved by a third reviewer.
Seven clinical trials were included, with a total of 36,371 participants (66,511 person-years) between the ages of 2 and 45 years. The meta-analysis using the random-effects model estimated the efficacy of the vaccine at 44%, with a range from 25 to 59% and high heterogeneity (I = 80.1%). The serotype-stratified meta-analysis was homogeneous, except for serotype 2, with the heterogeneity of 64.5%. Most of the vaccinated individuals had previous immunity for at least one serotype, which generated safety concerns in individuals without previous immunity.
Compared with other commercially available vaccines, the dengue vaccine showed poor efficacy.
登革热是一种虫媒病毒，已在全球迅速传播，近几十年来登革热的发病率大幅上升。实际登革热病例数量报告不足，许多病例分类不正确。最近的估计表明，每年有 3.9 亿例登革热感染（95%CI，2.84-5.28 亿），其中 9600 万（6700-1.36 亿）为任何严重程度的有症状感染。世界卫生组织的目标之一是到 2020 年将登革热死亡率降低 50%。疫苗的使用可以是实现这一目标的重要策略。登革热疫苗处于不同的开发阶段；在巴西，只有一种商业制剂（CYD-TDV）可用，由赛诺菲巴斯德开发。
为了评估登革热疫苗的疗效，对 2000 年至 2017 年间在 MEDLINE 数据库通过 PubMed、LILACS、Cochrane 图书馆和 EMBASE 检索到的随机对照临床试验进行了系统评价和荟萃分析。选择由两名评审员独立进行，如果有分歧则由第三名评审员解决。
纳入了 7 项临床试验，共有 36371 名 2 至 45 岁的参与者（66511 人年）。使用随机效应模型的荟萃分析估计疫苗的疗效为 44%，范围为 25%至 59%，且异质性较高（I=80.1%）。血清型分层荟萃分析除血清型 2 外均具有同质性，血清型 2 的异质性为 64.5%。大多数接种疫苗的个体对至少一种血清型具有既往免疫力，这引起了对无既往免疫力个体的安全性担忧。
与其他市售疫苗相比，登革热疫苗的疗效较差。
