Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial.
用两剂麻疹-腮腺炎-风疹-水痘联合疫苗或一剂单价水痘疫苗预防水痘: 3 期多中心、观察者盲的 10 年随访, 随机对照试验。

摘要

BACKGROUND:The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella.
METHODS:This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499.
FINDINGS:Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths.
INTERPRETATION:The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination.
FUNDING:GlaxoSmithKline Biologicals.

译文

背景: 水痘疫苗提供的保护期限尚不清楚。我们评估了两剂麻疹-腮腺炎-风疹-水痘联合疫苗 (MMRV) 、一种水痘减毒活疫苗 (V) 的 10 年疫苗效力在麻疹-腮腺炎-风疹疫苗 (MMR) 剂量 (mrv) 后给予的剂量,与预防确诊水痘的两次 MMR 剂量 (控制疫苗) 相比。
方法: 这是一项观察盲、随机、对照试验的 3b 期随访。在 a 阶段,来自捷克共和国 (捷克) 、希腊、意大利、立陶宛、挪威、波兰、罗马尼亚、俄罗斯、斯洛伐克、瑞典被电脑生成的随机列表 (3:3:1) 随机分配接受两剂 MMRV,一剂 MMR 和一剂水痘疫苗,或两剂 MMR,相隔 42 天。水痘病例由一个独立的数据监测委员会通过检测病毒 DNA 或流行病学联系和临床评估得到证实; 疾病严重程度基于修改后的巴斯克斯量表。在使用 Cox 比例风险回归模型的每个协议队列中估计的 MMRV 和 MMRV 与 MMR 的风险比被用来计算疫苗功效和 95% 置信区间。在整个研究过程中,所有接种疫苗的儿童都记录了严重的不良事件。研究目标为次要的和描述性的。该试验在 ClinicalTrials.gov 注册,编号为 nct00226499。
调查结果: 2005 至 2006年5月10日间,5803 名儿童 (平均年龄 14 · 2 个月,SD 2 · 5) 接种了疫苗。按方案队列包括 2279 名 MMRV 组儿童、 2266 名 MMRV 组儿童和 744 名 MMR 组儿童。从基线到 9 · 8 年的中位随访,MMRV 组 76 名 (3%) 儿童,MMRV 组 469 名 (21%),352 名 (47%) 在 MMR 组有水痘。MMRV 对所有水痘的疫苗效力为 95 · 4% (95% CI 94 · 0-96 · 4) 和 67 · 2% (62 · 3-71 · 5) 对于 mmr-v; 疫苗对中度或重度水痘的疗效为 99 · 1% (97 · 9-99 · 6) 对于 MMRV 和 89 · 5% (86 · 1-92 · 1) 对于 MMR  v v。在 b 阶段,MMRV 组 290 (15%) 的 1961年儿童、 MMRV 组 317 (16%) 的 1978年儿童和 93 (15%) 的儿童报告了严重不良事件 MMR 组的 641。没有与治疗相关的死亡。
解释: 观察到的 10 年疫苗功效, 表明两剂水痘疫苗为预防水痘提供了最佳的长期保护,通过提供个人保护来预防疾病的严重程度,并导致传播的潜在减少, 正如美国普遍大规模疫苗接种经验所观察到的。
资金来源: 葛兰素史克生物制品公司。

Mumps

呼吸 腮腺炎病毒引起的急性呼吸道传染病 疾病
概述  :  

疾病概述 流行性腮腺炎是由腮腺炎病毒所引起的急性呼吸道传染病。以腮腺非化脓性炎症、腮腺区肿痛为临床特征。主要发生在儿童和青少年中。腮腺炎病毒除侵犯腮腺外,尚能侵犯神经系统及各种腺体组织、引起脑膜炎、脑膜脑炎、睾丸炎、卵巢炎和胰腺炎等。 病原学腮腺炎病毒属于副黏病毒科副黏病毒属的单股 RNA 病毒。呈球形,大小悬殊,直径在100~200 nm之间。该病毒抗原结构稳定,只有一个血清型。但依据小的疏水蛋白,基因序列的差异至少分为A~J 10个基因型。此病毒有6种

Mumps   /mʌmps/

释    义   n. [内科] 流行性腮腺炎;愠怒;生气

例    句   The most common adverse reactions following mumps vaccination are parotitis  and/or submaxillary gland swelling and low-grade fever. 在接种流行性腮腺炎疫苗后最常见的不良反应是腮腺炎和/或颔下腺肿胀以及低热。

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