美国 50 岁及以上成人中重组带状疱疹疫苗的有效性：一项基于理赔的队列研究。
Effectiveness of the Recombinant Zoster Vaccine in Adults Aged 50 and Older in the United States: A Claims-Based Cohort Study.
机构信息
F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA.
Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA.
出版信息
Clin Infect Dis. 2021 Sep 15;73(6):949-956. doi: 10.1093/cid/ciab121.
BACKGROUND
The recombinant zoster vaccine had over 90% efficacy in preventing herpes zoster in clinical trials. However, its effectiveness outside of a clinical trial setting has not been investigated. This study aimed to assess the effectiveness of the recombinant zoster vaccine in general practice.
METHODS
A de-identified administrative claims database, the OptumLabs Data Warehouse, was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against herpes zoster in nonimmunocompromised, vaccine age-eligible individuals enrolled in the database for ≥365 days.
RESULTS
A total of 4 769 819 adults were included in this study, with 173 745 (3.6%) adults receiving 2 valid doses of the recombinant zoster vaccine. The incidence rate of herpes zoster was 258.8 (95% confidence interval [CI], 230.0-289.4) cases per 100 000 person-years in vaccinated persons compared with 893.1 (95% CI, 886.2-900.0) in unvaccinated persons. Recombinant zoster vaccine effectiveness was 85.5% (95% CI, 83.5-87.3%) overall, with an effectiveness of 86.8% (95% CI, 84.6-88.7%) in individuals 50 to 79 years old compared with 80.3% (95% CI, 75.1-84.3%) in individuals aged 80 and older. In patients with a history of live zoster vaccine within 5 years of study inclusion, vaccine effectiveness was 84.8% (95% CI, 75.3-90.7%).
CONCLUSIONS
Recombinant zoster vaccine effectiveness against herpes zoster was high in a real-world setting. Given the low vaccine coverage and high effectiveness, a major public health effort is needed to identify and address barriers to vaccination and increase immunization rates.
背景
在临床试验中，重组带状疱疹疫苗在预防带状疱疹方面的有效性超过 90%。然而，其在临床试验环境之外的有效性尚未得到研究。本研究旨在评估重组带状疱疹疫苗在一般实践中的效果。
方法
本回顾性队列研究使用去标识化的行政索赔数据库——OptumLabs 数据仓库，评估非免疫功能低下、符合疫苗接种年龄的数据库中登记时间≥365 天的个体中重组带状疱疹疫苗预防带状疱疹的有效性。
结果
本研究共纳入 4769819 名成年人，其中 173745 名（3.6%）成年人接种了 2 剂有效的重组带状疱疹疫苗。在接种者中，带状疱疹的发病率为每 100000 人年 258.8（95%置信区间[CI]，230.0-289.4）例，而未接种者为 893.1（95%CI，886.2-900.0）例。重组带状疱疹疫苗的总体有效性为 85.5%（95%CI，83.5-87.3%），50-79 岁人群的有效性为 86.8%（95%CI，84.6-88.7%），80 岁及以上人群的有效性为 80.3%（95%CI，75.1-84.3%）。在研究纳入前 5 年内有带状疱疹活疫苗接种史的患者中，疫苗有效性为 84.8%（95%CI，75.3-90.7%）。
结论
在真实环境中，重组带状疱疹疫苗预防带状疱疹的有效性很高。鉴于疫苗接种率低且有效性高，需要开展重大的公共卫生努力，以确定和解决疫苗接种障碍，提高免疫接种率。
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