本文由小咖机器人翻译整理

期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-2023

摘要内容如下：

背景

在一项关键的临床试验中，2剂系列重组带状疱疹疫苗（RZV）对带状疱疹（Hz）的有效率为97%。

目的

评估RZV对Hz的实际有效性。

设计

前瞻性队列研究。

设置

疫苗安全数据链中的四个卫生保健系统。

参与者

50岁或以上的人。

测量

结果是由抗病毒处方诊断定义的偶发Hz。Cox回归用于估计接种疫苗者与未接种疫苗者相比Hz的危害，并对协变量进行调整。疫苗有效性（VE）计算为1减去调整后的风险比，并通过自最后一次RZV剂量以来的时间和皮质类固醇的使用来估计。

结果

该研究包括近200万人，他们提供了760万人年的随访。调整后，1剂VE为64%，2剂VE为76%。仅1剂后，VE在第一年为70%，第二年为45%，第三年为48%，第三年后为52%。2次给药后，第一年VE为79%，第二年为75%，第三年和第四年为73%。在疫苗接种前接受皮质类固醇的人群中，疫苗的有效性为65%，而在未接受皮质类固醇的人群中，疫苗的有效性为77%。

局限性

在这些观察数据中，不能像在以前的临床试验中那样准确地识别带状疱疹。

结论

两个剂量的RZV非常有效，尽管效果不如以前的临床试验。在4年的随访中，两剂的疗效几乎没有减弱。然而，一次剂量的有效性在一年后显著减弱，强调了第二次剂量的重要性。

英文原文如下：

Abstracts

BACKGROUND  A 2-dose series of recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ) in a pivotal clinical trial.

OBJECTIVE  To evaluate real-world effectiveness of RZV against HZ.

DESIGN  Prospective cohort study.

SETTING  Four health care systems in the Vaccine Safety Datalink.

PARTICIPANTS  Persons aged 50 years or older.

MEASUREMENTS  The outcome was incident HZ defined by a diagnosis with an antiviral prescription. Cox regression was used to estimate the hazard of HZ in vaccinated persons compared with unvaccinated persons, with adjustment for covariates. Vaccine effectiveness (VE) was calculated as 1 minus the adjusted hazard ratio and was estimated by time since the last RZV dose and by corticosteroid use.

RESULTS  The study included nearly 2.0 million persons who contributed 7.6 million person-years of follow-up. After adjustment, VE of 1 dose was 64% and VE of 2 doses was 76%. After 1 dose only, VE was 70% during the first year, 45% during the second year, 48% during the third year, and 52% after the third year. After 2 doses, VE was 79% during the first year, 75% during the second year, and 73% during the third and fourth years. Vaccine effectiveness was 65% in persons who received corticosteroids before vaccination and 77% in those who did not.

LIMITATION  Herpes zoster could not be identified as accurately in these observational data as in the previous clinical trials.

CONCLUSION  Two doses of RZV were highly effective, although less effective than in the previous clinical trials. Two-dose effectiveness waned very little during the 4 years of follow-up. However, 1-dose effectiveness waned substantially after 1 year, underscoring the importance of the second dose.

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