From the Centro de Atención e Investigación Médica - CAIMED, Bogotá, Colombia.
Fundación Santa Fe de Bogotá, Bogotá, Colombia.
Pediatr Infect Dis J. 2020 Apr;39(4):e30-e36. doi: 10.1097/INF.0000000000002580.
The efficacy of the recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) against virologically-confirmed dengue (VCD) has been documented in a phase 3 trial in Latin America (CYD15, NCT01374516). This is a descriptive secondary analysis of the efficacy and safety of CYD-TDV in participants from Colombia.
Data from 9740 Colombian participants 9-16 years of age who were randomized 2:1 to receive CYD-TDV or placebo were assessed to describe the vaccine efficacy of CYD-TDV against VCD and severe VCD. Estimation was made of the relative risk (RR) for hospitalized VCD cases and severe hospitalized VCD cases after the first dose of CYD-TDV, as well as a description of the incidence of hospitalized dengue from the start of the study and per year of the study until study completion.
During the active phase of the trial in Colombia, the efficacy of CYD-TDV was 67.5% [95% confidence interval (CI): 58.3-74.7] against symptomatic VCD due to any serotype from injection 1 (month 0) to 25 months postinjection 1. Over 6 years, the RR across all 4 serotypes was 0.166 (95% CI: 0.09-0.29) in hospitalized VCD patients and 0.154 (95% CI: 0.04-0.50) in patients with severe hospitalized VCD.
Analysis of the data from Colombia mimics the efficacy observed in CYD15 during the active surveillance follow-up (25 months), but with a sustained beneficial RR for dengue hospitalizations on the subsequent years of follow-up. In Colombia, where seroprevalence has been demonstrated to be high in several regions of the country, CYD-TDV is a useful tool to consider as part of an integrated control strategy against endemic dengue, a disease with a high economic impact on the health system.
重组、减毒、四价登革热疫苗（CYD-TDV）在拉丁美洲的一项 3 期临床试验中已证明对病毒确诊的登革热（VCD）有效（CYD15，NCT01374516）。这是对哥伦比亚参与者中 CYD-TDV 的疗效和安全性的描述性二次分析。
评估了 9740 名年龄为 9-16 岁的哥伦比亚参与者的数据，他们以 2:1 的比例随机接受 CYD-TDV 或安慰剂，以描述 CYD-TDV 对 VCD 和严重 VCD 的疫苗疗效。估计了首次接受 CYD-TDV 后住院 VCD 病例和严重住院 VCD 病例的相对风险（RR），以及从研究开始到研究结束期间每年住院登革热的发病率。
在哥伦比亚试验的活跃阶段，CYD-TDV 的疗效为 67.5%[95%置信区间（CI）：58.3-74.7]，针对任何血清型的症状性 VCD，从第 1 次注射（0 个月）到第 1 次注射后 25 个月。在 6 年多的时间里，4 种血清型的住院 VCD 患者的 RR 为 0.166（95%CI：0.09-0.29），严重住院 VCD 患者的 RR 为 0.154（95%CI：0.04-0.50）。
对哥伦比亚数据的分析模仿了 CYD15 在主动监测随访（25 个月）期间观察到的疗效，但在随后的随访年份中，登革热住院的 RR 持续有益。在哥伦比亚，该国几个地区的血清流行率已被证明很高，CYD-TDV 是作为针对地方性登革热的综合控制策略的有用工具，这种疾病对卫生系统有很大的经济影响。
