在免疫功能正常和免疫功能低下的受试者中，带状疱疹疫苗的疗效、效果和安全性：系统评价和网络荟萃分析。
Efficacy, effectiveness, and safety of herpes zoster vaccine in the immunocompetent and immunocompromised subjects: A systematic review and network meta-analysis.
机构信息
Institute of Infectious Disease and Vaccine, School of Public Health, Zhejiang Chinese Medical University, Hangzhou, China.
出版信息
Front Immunol. 2022 Sep 30;13:978203. doi: 10.3389/fimmu.2022.978203. eCollection 2022.
OBJECTIVE
To investigate the efficacy, effectiveness and safety of recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL) in immunocompetent and immunocompromised subjects.
METHODS
Data sources: PubMed, EMBASE, Cochrane Library, and Web of Science databases (up to Jan 2022) were searched to identify English articles. Search terms included randomized controlled trials (RCTs), observational studies, herpes zoster, RZV, ZVL. Study Selection: Only randomized controlled trials (RCTs) evaluating vaccine efficacy and safety and observational studies assessing vaccine effectiveness (after a vaccine was approved for marketing) were included. Data Extraction: Two researchers independently screened the literature, extracted the data, and checked the each other results.
RESULTS
Seventeen RCTs and 19 cohort studies were included. Among immunocompetent subjects, RZV was superior to ZVL at wide intervals (relative vaccine efficacy: 84%, 95% CI: 53%-95%; relative vaccine effectiveness: 49%, 95% CI: 21%-67%), across genders and subjects aged ≥ 60 years. Among immunocompromised subjects, RZV was superior to placebo in terms of vaccine efficacy (60%, 95% CI: 49%-69%). There was no difference between ZVL and placebo in those with selected immunosuppressive conditions. RZV was 45% (95% CI: 30%-59%) superior to ZVL in real-world practice. Compared with placebo, adverse events related to RZV were primarily related to injection-site and systemic, and RZV did not increase the risk of serious adverse events (SAEs) or death. There was no difference in the incidence of adverse events between groups with and without immunosuppression.
CONCLUSIONS
Both RZV and ZVL can reduce the risk of herpes zoster in both immunocompetent and immunocompromised subjects. RZV was well-tolerated in the study population and demonstrated stronger protection than ZVL.
SYSTEMATIC REVIEW REGISTRATION
Prospero CRD42022310495.
目的
研究重组带状疱疹疫苗（RZV）和带状疱疹活疫苗（ZVL）在免疫功能正常和免疫功能低下受试者中的疗效、有效性和安全性。
方法
数据来源：检索PubMed、EMBASE、Cochrane 图书馆和 Web of Science 数据库（截至 2022 年 1 月）以获取英文文章。检索词包括随机对照试验（RCT）、观察性研究、带状疱疹、RZV、ZVL。研究选择：仅纳入评估疫苗疗效和安全性的随机对照试验（RCT）和评估疫苗有效性（疫苗获得上市批准后）的观察性研究。数据提取：两名研究人员独立筛选文献、提取数据并核对彼此的结果。
结果
纳入了 17 项 RCT 和 19 项队列研究。在免疫功能正常的受试者中，RZV 与 ZVL 相比在宽间隔（相对疫苗效力：84%，95%CI：53%-95%；相对疫苗效果：49%，95%CI：21%-67%）、各性别和≥60 岁的受试者中均表现出优越性。在免疫功能低下的受试者中，RZV 在疫苗效力方面优于安慰剂（60%，95%CI：49%-69%）。在具有特定免疫抑制条件的受试者中，ZVL 与安慰剂之间没有差异。在真实世界实践中，RZV 比 ZVL 优越 45%（95%CI：30%-59%）。与安慰剂相比，与 RZV 相关的不良反应主要与注射部位和全身有关，RZV 并未增加严重不良事件（SAE）或死亡的风险。有免疫抑制和无免疫抑制组之间的不良反应发生率没有差异。
结论
RZV 和 ZVL 均可降低免疫功能正常和免疫功能低下受试者带状疱疹的风险。在研究人群中，RZV 具有良好的耐受性，并且比 ZVL 提供更强的保护。
系统评价注册
Prospéro CRD42022310495。
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