Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine.

A single-dose dengue vaccine that protects against the four DENV serotypes across a wide age range and regardless of DENV serostatus is needed.

需要一种单剂登革疫苗，该疫苗能广泛保护各个年龄段的人群，并且不受DENV血清状态的影响，从而预防四种DENV血清型。

Here we report the long-term safety and efficacy of Butantan dengue vaccine (Butantan-DV), a live, attenuated, tetravalent dengue vaccine, among participants ages 2-59 who were randomized 2:1 in a double-blind, placebo-controlled, phase 3 trial in Brazil.

在这里，我们报告了Butantan登革热疫苗（Butantan-DV），一种活的、减毒的、四价登革热疫苗，在巴西进行的双盲、安慰剂对照的3期临床试验中，针对2-59岁的参与者，他们按照2:1的比例随机分组，长期的安全性和有效性。

A primary objective was to evaluate vaccine efficacy (VE) against reverse transcription-PCR-positive symptomatic dengue 28 days after vaccination because of any DENV serotype, regardless of serostatus.

主要目标是评估疫苗效力（VE），在接种疫苗后28天内，针对任何DENV血清型引起的逆转录PCR阳性的有症状登革热，无论血清状态如何。

Prespecified secondary endpoints included VE by serotype, by serostatus and against severe dengue or dengue with warning signs (combined).

预设的次要终点包括按血清型、血清状态以及针对严重登革热或有警告症状的登革热（结合）的疫苗效力（VE）。

The primary and secondary objectives were met if the lower bound of the two-sided 95% confidence interval(CI) for VE was above 25%.

如果疫苗效力（VE）的双侧95%置信区间（CI）的下限高于25%，则认为主要和次要目标已经实现。

Between 2016 and 2019, 16,235 participants received Butantan-DV (n = 10,259) or placebo (n = 5,976).

在2016年至2019年期间，共有16,235名参与者接受了Butantan-DV（n = 10,259）或安慰剂（n = 5,976）。

The trial met the primary and secondary objectives.

该试验达到了主要和次要研究目标。

During the 5 years of follow-up, between 2016 and 2024, overall VE (95% CI) was 65.0% (57.8-71.0%).

在2016年至2024年之间的5年随访期间，总体疫苗效力（95%置信区间）为65.0%（57.8-71.0%）。

Secondary VE endpoints (95% CI) were 77.1% (67.6-83.9%) in dengue-experienced participants, 58.9% (48.0-67.6%) in dengue-naive participants, 73.0% (64.3-79.7%) against DENV-1 and 55.7% (42.3-66.1%) against DENV-2.

次要疫苗效力终点（95%置信区间）在有登革热经验的参与者中为77.1%（67.6-83.9%），在无登革热经验的参与者中为58.9%（48.0-67.6%），对DENV-1的效力为73.0%（64.3-79.7%），对DENV-2的效力为55.7%（42.3-66.1%）。

Cases of DENV-3 or DENV-4 were not observed.

未观察到登革热病毒3型或4型的病例。

VE (95% CI) against dengue with warning signs or severe dengue (secondary endpoint) was 80.5% (50.8-92.4%).

针对有警告症状的登革热或严重登革热的疫苗效果（次要终点）为80.5%（95%置信区间50.8-92.4%）。

The most commonly reported solicited systemic adverse event(AE) was headache (36.7% of vaccine recipients and 31.1% of placebo recipients), most of which were grade 1.

报告的最常见系统性不良事件（AE）是头痛（疫苗接受者为36.7%，安慰剂接受者为31.1%），其中大多数为1级。

The proportions of participants with unsolicited vaccine-related AEs (including serious AEs) were comparable between intervention groups.

两组干预措施中，非计划的疫苗相关不良事件（包括严重不良事件）的发生比例相当。

A single dose of Butantan-DV was efficacious against symptomatic virologically confirmed dengue because of DENV-1 or DENV-2, regardless of dengue serostatus at baseline, with no safety concerns observed during the 5-year follow-up (ClinicalTrials.gov: NCT02406729 ).

单剂量的Butantan-DV对于因DENV-1或DENV-2引起的症状性病毒学确诊登革热有效，无论基线时的登革热血清状态如何，在5年的随访期间未观察到任何安全问题（ClinicalTrials.gov: NCT02406729）。