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带状疱疹疫苗的疗效和安全性比较:网状荟萃分析。

The comparative efficacy and safety of herpes zoster vaccines: A network meta-analysis.

机构信息

GSK Canada, 7333 Mississauga Rd N, Mississauga, ON L5N 6L4, Canada.

GSK Canada, 7333 Mississauga Rd N, Mississauga, ON L5N 6L4, Canada.

出版信息

Vaccine. 2019 May 16;37(22):2896-2909. doi: 10.1016/j.vaccine.2019.04.014. Epub 2019 Apr 11.

Abstract

BACKGROUND

We estimated the relative efficacy and safety of vaccines for prevention of herpes zoster (HZ) using network meta-analysis (NMA) based on evidence from randomized controlled trials.

METHODS

A systematic literature review evaluated two different HZ vaccines: adjuvanted recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL), with different formulations assessed. Detailed feasibility assessment indicated that a NMA was feasible for efficacy (incidence of HZ and postherpetic neuralgia [PHN]) and safety (serious adverse events [SAE] and reactogenicity [injection-site reactions, systemic reaction]) outcomes. Primary analyses included frequentist NMAs with fixed effects for efficacy outcomes, due to limited data availability, and both fixed and random effects for safety and reactogenicity outcomes. As age is a known effect modifier of vaccine efficacy (VE), VE analyses were stratified by age.

RESULTS

RZV demonstrated significantly higher HZ efficacy than ZVL in adults ≥60 years of age (YOA) (VE = 0.92 (95% confidence interval [95%CI]: 0.88, 0.94), VE = 0.51 (95%CI: 0.44, 0.57)) and adults ≥70 YOA (VE = 0.91 (95%CI: 0.87, 0.94), VE = 0.37 (95%CI: 0.25, 0.48)). Similarly, RZV demonstrated significantly higher PHN efficacy than ZVL in adults ≥60 YOA (VE = 0.89 (95%CI: 0.70, 0.96), VE = 0.66 (95%CI: 0.48, 0.78)) and adults ≥70 YOA (VE = 0.89 (95%CI: 0.69, 0.96), VE = 0.67 (95%CI: 0.44, 0.80)). RZV was associated with significantly more injection-site and systemic reactions compared to most formulations of ZVL and placebo, however definitions and data collection procedures differed across the included studies. There were no statistically significant differences found between RZV and any formulation of ZVL or placebo for SAEs.

CONCLUSION

RZV is significantly more effective in reducing HZ and PHN incidence in adults ≥60 YOA, compared with ZVL. As anticipated with an adjuvanted vaccine, RZV results in more reactogenicity following immunization. No differences in SAEs were found between RZV and ZVL.

摘要

背景

我们使用基于随机对照试验证据的网络荟萃分析(NMA)来估计预防带状疱疹(HZ)的疫苗的相对疗效和安全性。

方法

系统文献综述评估了两种不同的 HZ 疫苗:佐剂重组带状疱疹疫苗(RZV)和带状疱疹活疫苗(ZVL),评估了不同的制剂。详细的可行性评估表明,对于疗效(HZ 和带状疱疹后神经痛[PHN]的发生率)和安全性(严重不良事件[SAE]和反应原性[注射部位反应、全身反应])结局,进行 NMA 是可行的。由于数据有限,主要分析包括对疗效结局进行固定效应的频率派 NMA,对安全性和反应原性结局进行固定效应和随机效应的 NMA。由于年龄是疫苗疗效(VE)的已知效应修饰因子,因此对 VE 分析进行了年龄分层。

结果

在≥60 岁的成年人(YOA)中,RZV 显示出比 ZVL 更高的 HZ 疗效(VE=0.92(95%置信区间[95%CI]:0.88,0.94),VE=0.51(95%CI:0.44,0.57))和≥70 岁的成年人(VE=0.91(95%CI:0.87,0.94),VE=0.37(95%CI:0.25,0.48))。同样,在≥60 岁的成年人(VE=0.89(95%CI:0.70,0.96),VE=0.66(95%CI:0.48,0.78))和≥70 岁的成年人(VE=0.89(95%CI:0.69,0.96),VE=0.67(95%CI:0.44,0.80))中,RZV 也显示出比 ZVL 更高的 PHN 疗效。与 ZVL 和安慰剂的大多数制剂相比,RZV 引起的注射部位和全身反应明显更多,然而,纳入的研究中,定义和数据收集程序存在差异。在 RZV 和 ZVL 的任何制剂或安慰剂之间未发现 SAE 有统计学意义的差异。

结论

与 ZVL 相比,RZV 可显著降低≥60 岁成年人 HZ 和 PHN 的发病率。与佐剂疫苗一致,RZV 会导致免疫后反应原性增加。在 SAE 方面,RZV 与 ZVL 之间无差异。

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