本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02031-7

摘要内容如下：

背景

在非洲和亚洲儿童中进行的伤寒结合疫苗随机对照试验显示了较高的短期疗效。关于超过2年的保护的持久性的数据很少。我们对马拉维的一项随机对照试验进行了最终分析，包括超过4年的随访，目的是调查疫苗随时间和年龄组的效力。

方法

在马拉维布兰太尔进行的这一3期、双盲、随机对照效力试验中，无盲统计员将9个月至12岁的健康儿童随机分配（1:1）接受单剂破伤风类毒素疫苗Vi多糖结合物（Vi-TT）或A群脑膜炎球菌荚膜结合物（MENA）疫苗。儿童必须没有伤寒疫苗接种史，居住在研究地区，并从公立学校和卫生中心招募。参与者，他们的父母或监护人，以及研究小组对疫苗分配进行了屏蔽。接种疫苗的护士被揭露。从疫苗接种到随访结束，我们对发热性疾病进行了监测。主要转归是首次发生经血培养证实的伤寒。随机分配并接种疫苗的合格儿童被纳入意向治疗分析。该试验在ClinicalTrials.gov，NCT03299426上注册。

调查结果

2018年2月21日至2018年9月27日，28130名儿童接种了疫苗；14069人被指定接收VI-TT，14061人被指定接收MENA。中位随访4.3年（IQR 4.2-4.5）后，VI-TT组24例（39.7例/100，000人-年）和MENA组110例（182.7例/100，000人-年）儿童被诊断为首次经血培养确诊的伤寒。在意向治疗人群中，VI-TT的有效率为78.3%（95%CI 66.3-86.1），163（129-222）名儿童需要接种疫苗才能预防1例病例。9个月至2岁儿童的有效率为70.6%（6.4-93.0）；2-4岁儿童为79.6%（45.8-93.9）；5~12岁儿童为79.3%（63.5~89.0）。

解释

在9个月至12岁的儿童中，单剂量的VI-TT至少在4年内持续有效，并在所有年龄组中显示出疗效，包括2岁以下的儿童。这些结果支持世卫组织目前的建议，即在伤寒流行地区对9个月至15岁的儿童开展大规模运动，然后在出生后的头两年进行常规干预。

英文原文如下：

Abstracts

BACKGROUND  Randomised controlled trials of typhoid conjugate vaccines among children in Africa and Asia have shown high short-term efficacy. Data on the durability of protection beyond 2 years are sparse. We present the final analysis of a randomised controlled trial in Malawi, encompassing more than 4 years of follow-up, with the aim of investigating vaccine efficacy over time and by age group.

METHODS  In this phase 3, double-blind, randomised controlled efficacy trial in Blantyre, Malawi, healthy children aged 9 months to 12 years were randomly assigned (1:1) by an unmasked statistician to receive a single dose of Vi polysaccharide conjugated to tetanus toxoid vaccine (Vi-TT) or meningococcal capsular group A conjugate (MenA) vaccine. Children had to have no previous history of typhoid vaccination and reside in the study areas for inclusion and were recruited from government schools and health centres. Participants, their parents or guardians, and the study team were masked to vaccine allocation. Nurses administering vaccines were unmasked. We did surveillance for febrile illness from vaccination until follow-up completion. The primary outcome was first occurrence of blood culture-confirmed typhoid fever. Eligible children who were randomly assigned and vaccinated were included in the intention-to-treat analyses. This trial is registered at ClinicalTrials.gov, NCT03299426.

FINDINGS  Between Feb 21, 2018, and Sept 27, 2018, 28 130 children were vaccinated; 14 069 were assigned to receive Vi-TT and 14 061 to receive MenA. After a median follow-up of 4·3 years (IQR 4·2-4·5), 24 (39·7 cases per 100 000 person-years) children in the Vi-TT group and 110 (182·7 cases per 100 000 person-years) children in the MenA group were diagnosed with a first episode of blood culture-confirmed typhoid fever. In the intention-to-treat population, efficacy of Vi-TT was 78·3% (95% CI 66·3-86·1), and 163 (129-222) children needed to be vaccinated to prevent one case. Efficacies by age group were 70·6% (6·4-93·0) for children aged 9 months to 2 years; 79·6% (45·8-93·9) for children aged 2-4 years; and 79·3% (63·5-89·0) for children aged 5-12 years.

INTERPRETATION  A single dose of Vi-TT is durably efficacious for at least 4 years among children aged 9 months to 12 years and shows efficacy in all age groups, including children younger than 2 years. These results support current WHO recommendations in typhoid-endemic areas for mass campaigns among children aged 9 months to 15 years, followed by routine introduction in the first 2 years of life.

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