PDF(Pubmed)
Abstract：
Several concerns have been raised about a causal relationship between COVID-19 mRNA-based vaccines and the development of herpes zoster (HZ). We performed a prospective analysis of the Vax-On-Third-Profile study to investigate the incidence of HZ after the third dose of mRNA-BNT162b2 (tozinameran) and its correlation with immune responses. Patients who had received a booster dose and had been actively treated for at least 8 weeks were eligible. Serologic assessment was performed before the third dose of tozinameran (timepoint-1) and 4 weeks later (timepoint-2). We also assessed the incidence of SARS-CoV-2 breakthrough infections at predefined time points. The current analysis included 310 patients, of whom 109 (35.2%) and 111 (35.8%) were being treated with targeted therapies and cytotoxic chemotherapy, respectively. All participants received a third dose of tozinameran between September 26 and October 30, 2021. After a mean follow-up of 17.3 (IQR 15.1-18.4) months, HZ occurred in 8 recipients, for a cumulative incidence of 2.6%, and an incidence rate of 0.310 per person-year (95% CI 0.267-0.333). All HZ cases occurred within 30 days of booster dosing (range 5-29 days), with a median time to onset of 15 (IQR 9-22) days. Among the 7 patients (2.2%) who also contracted a SARS-CoV-2 infection, all cases preceded COVID-19 outbreaks. No instances of complicated HZ were reported. In multivariate analysis, impaired T helper and T cytotoxic cell counts independently correlated with HZ occurrence. These findings provide the first evidence that cancer patients on active treatment have a not negligible risk of developing HZ within 30 days after the third dose of tozinameran. The favorable clinical outcome of all observed cases confirms that protective effects of boosters in reducing the risk of severe COVID-19 outweigh the potential risk of HZ occurrence.
摘要：
人们对基于COVID-19mRNA的疫苗与带状疱疹（HZ）的发展之间的因果关系提出了一些担忧。我们对Vax-On-Third-Profile研究进行了前瞻性分析，以研究第三剂mRNA-BNT162b2（tozinameran）后HZ的发生率及其与免疫反应的相关性。接受加强剂量并积极治疗至少8周的患者符合条件。血清学评估在第三剂量的tozinameran之前(时间点-1)和4周后(时间点-2)进行。我们还评估了在预定时间点的SARS-CoV-2突破性感染的发生率。目前的分析包括310名患者，其中109（35.2％）和111（35.8％）正在接受靶向治疗和细胞毒性化疗，分别。所有参与者在2021年9月26日至10月30日期间接受了第三剂tozinameran。平均随访17.3(IQR15.1-18.4)个月后，HZ发生在8个收件人中，累积发病率为2.6%，发病率为每人每年0.310（95%CI0.267-0.333）。所有HZ病例均发生在加强给药30天内（范围5-29天），中位发病时间为15天（IQR9-22天）。在7名同时感染SARS-CoV-2的患者(2.2%)中，所有病例都在COVID-19爆发之前。没有报告复杂的HZ实例。在多变量分析中，受损的T辅助细胞和T细胞毒性细胞计数与HZ的发生独立相关。这些发现提供了第一个证据，表明积极治疗的癌症患者在服用第三剂tozinameran后30天内发生HZ的风险不可忽视。所有观察到的病例的良好临床结果证实，助推器在降低严重COVID-19风险方面的保护作用超过了HZ发生的潜在风险。
