本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2301790

摘要内容如下：

背景

Buttan-登革热疫苗（Buttan-DV）是一种针对登革热的试验性、单剂量、减毒活四价疫苗，但需要关于其总体效力的数据。

方法

在巴西正在进行的一项3期双盲试验中，我们将参与者随机分配接受布坦坦-DV或安慰剂，并根据年龄分层（2至6岁、7至17岁和18至59岁）；计划随访5年。该试验的目的是评估疫苗对接种后超过28天（主要效力终点）出现的任何血清型的有症状的、病毒学证实的登革热的总体效力，而不考虑基线时的血清状态，并描述直到第21天（主要安全性终点）的安全性。在此，根据每个参与者2年的随访来评估疫苗的效力，以及在注射后第21天报告的疫苗相关不良事件的安全性。关键的次要目标是根据基线时的登革病毒血清状态和登革病毒血清型评估参与者的疫苗效力；还根据年龄评估了疗效。

结果

在为期3年的登记期间，16，235名参与者接受了布坦坦-DV（10，259名参与者）或安慰剂（5976名参与者）。在既往无登革热暴露史的参与者中，2年疫苗总有效率为79.6%（95%可信区间[CI]，70.0至86.3）-73.6%（95%CI，57.6至83.7），在有登革热暴露史的参与者中，2年疫苗总有效率为89.2%（95%CI，77.6至95.6）。在2至6岁的参与者中，疫苗效力为80.1%（95%CI，66.0至88.4）；在7至17岁的参与者中，疫苗效力为77.8%（95%CI，55.6至89.6）；在18至59岁的参与者中，疫苗效力为90.0%（95%CI，68.2至97.5）。对DENV-1的有效率为89.5%（95%CI，78.7至95.0），对DENV-2的有效率为69.6%（95%CI，50.8至81.5）。随访期间未检测到DENV-3和DENV-4。注射后21天内，与布坦坦-DV组相比，布坦坦-DV组发生的系统性疫苗或安慰剂相关不良事件更常见（58.3%的参与者对45.6%）。

结论

在2年的随访中，无论基线时的登革病毒血清状态如何，单剂量布坦坦-DV均可预防有症状的登革病毒-1和登革病毒-2。（由Instituto Butantan和其他机构资助；DEN-03-IB ClinicalTrials.gov编号，NCT02406729，WHO ICTRP编号，U1111-1168-8679。）

英文原文如下：

Abstracts

BACKGROUND  Butantan-Dengue Vaccine (Butantan-DV) is an investigational, single-dose, live, attenuated, tetravalent vaccine against dengue disease, but data on its overall efficacy are needed.

METHODS  In an ongoing phase 3, double-blind trial in Brazil, we randomly assigned participants to receive Butantan-DV or placebo, with stratification according to age (2 to 6 years, 7 to 17 years, and 18 to 59 years); 5 years of follow-up is planned. The objectives of the trial were to evaluate overall vaccine efficacy against symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination (the primary efficacy end point), regardless of serostatus at baseline, and to describe safety up to day 21 (the primary safety end point). Here, vaccine efficacy was assessed on the basis of 2 years of follow-up for each participant, and safety as solicited vaccine-related adverse events reported up to day 21 after injection. Key secondary objectives were to assess vaccine efficacy among participants according to dengue serostatus at baseline and according to the dengue viral serotype; efficacy according to age was also assessed.

RESULTS  Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) - 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure. Vaccine efficacy was 80.1% (95% CI, 66.0 to 88.4) among participants 2 to 6 years of age, 77.8% (95% CI, 55.6 to 89.6) among those 7 to 17 years of age, and 90.0% (95% CI, 68.2 to 97.5) among those 18 to 59 years of age. Efficacy against DENV-1 was 89.5% (95% CI, 78.7 to 95.0) and against DENV-2 was 69.6% (95% CI, 50.8 to 81.5). DENV-3 and DENV-4 were not detected during the follow-up period. Solicited systemic vaccine- or placebo-related adverse events within 21 days after injection were more common with Butantan-DV than with placebo (58.3% of participants, vs. 45.6%).

CONCLUSIONS  A single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up. (Funded by Instituto Butantan and others; DEN-03-IB ClinicalTrials.gov number, NCT02406729, and WHO ICTRP number, U1111-1168-8679.).

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