Medical Oncology Unit, Department of Oncology and Hematology, Central Hospital of Belcolle, Strada Sammartinese Snc, 01100, Viterbo, Italy.
Biostatistics Unit, Scientific Directorate, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Clin Exp Med. 2024 Jan 20;24(1):13. doi: 10.1007/s10238-023-01263-2.
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.
人们对 COVID-19 mRNA 疫苗与带状疱疹（HZ）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，以调查 mRNA-BNT162b2（tozinameran）第三剂后 HZ 的发生率及其与免疫反应的相关性。符合条件的患者接受了加强针注射，且已积极治疗至少 8 周。在接受 tozinameran 第三剂之前（时间点 1）和 4 周后（时间点 2）进行血清学评估。我们还在预设时间点评估了 SARS-CoV-2 突破性感染的发生率。本分析包括 310 例患者，其中 109 例（35.2%）和 111 例（35.8%）分别接受靶向治疗和细胞毒性化疗。所有患者均于 2021 年 9 月 26 日至 10 月 30 日期间接种第三剂 tozinameran。中位随访 17.3 个月（IQR 15.1-18.4）后，8 例患者发生 HZ，累积发生率为 2.6%，发病率为 0.310 人年（95%CI 0.267-0.333）。所有 HZ 病例均发生在加强针接种后 30 天内（范围 5-29 天），发病中位时间为 15 天（IQR 9-22）。在 7 例（2.2%）同时感染 SARS-CoV-2 的患者中，所有病例均先于 COVID-19 疫情。未报告复杂 HZ 病例。多变量分析表明，辅助性 T 细胞和细胞毒性 T 细胞计数受损与 HZ 发生独立相关。这些发现首次表明，接受积极治疗的癌症患者在接受 tozinameran 第三剂后 30 天内发生 HZ 的风险不容忽视。所有观察到的病例均有良好的临床结局，证实了加强针在降低 COVID-19 严重风险方面的保护作用大于发生 HZ 的潜在风险。
