Kupa Leonard V K, Medeiros-Ribeiro Ana Cristina, Aikawa Nádia E, Pasoto Sandra G, Borba Eduardo F, Assad Ana Paula L, Saad Carla G S, Yuki Emily F N, Seguro Luciana P C, Andrade Danieli, Shinjo Samuel K, Sampaio-Barros Percival D, Shimabuco Andrea Y, Moraes Júlio Cesar B, Sampaio Vanderson S, Giardini Henrique A M, Silva Clovis A A, Bonfá Eloisa
From the Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Instituto Todos pela Saúde (ITpS), Sao Paulo, SP, Brazil.
J Clin Rheumatol. 2025 Sep 1;31(6):e104-e111. doi: 10.1097/RHU.0000000000002216. Epub 2025 Mar 4.
Patients with autoimmune rheumatic diseases (ARDs) are at an increased risk for herpes zoster (HZ). Vaccination is recommended for this population.
The aim of this study was to evaluate the safety of vaccination with the recombinant zoster vaccine (Shingrix) in ARD patients, humoral immunogenicity (HI), cellular immunogenicity (CI), and the incidence of HZ.
This randomized, double-blind, placebo-controlled phase 4 study involves 1180 ARD patients and a control group (CG) of 393 balanced healthy individuals, aged ≥50 years. ARD patients will be randomly assigned in a blinded manner (1:1 ratio) to 2 groups: vaccine or placebo (on days 0 and 42), administered intramuscularly. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks after vaccination, including disease activity (using specific disease activity scores), HI, and CI. Adverse events will be assessed using a standardized questionnaire after each vaccine dose. Incident HZ cases will be monitored throughout the study. One year following the second dose, the persistence of HI and CI will be evaluated in both ARD patients and CG. HI and CI will be assessed using serum concentrations of anti-gE antibodies and the frequencies of gE-specific CD4+ T cells, respectively. Comparisons of anti-gE titers between ARD patients and CG at different time points will be analyzed using 2-way repeated-measures analysis of variance. Multiple regression analysis will be conducted, with a positive immune response as the dependent variable, and variables with p < 0.2 from univariate analysis as independent variables.
This large trial addresses a critical gap by examining disease safety, efficacy, adverse effects, and immunogenicity, considering the impact of diverse therapies following recombinant zoster vaccine administration in ARD patients.
自身免疫性风湿疾病（ARDs）患者发生带状疱疹（HZ）的风险增加。建议该人群接种疫苗。
本研究旨在评估重组带状疱疹疫苗（Shingrix）在ARD患者中的接种安全性、体液免疫原性（HI）、细胞免疫原性（CI）以及HZ发病率。
这项随机、双盲、安慰剂对照的4期研究纳入了1180例年龄≥50岁的ARD患者和一个由393名健康个体组成的平衡对照组（CG）。ARD患者将以盲法（1:1比例）随机分为两组：疫苗组或安慰剂组（分别在第0天和第42天），采用肌肉注射给药。在接种疫苗后的基线、6周和12周评估结果，包括疾病活动度（使用特定的疾病活动评分）、HI和CI。每次接种疫苗后，使用标准化问卷评估不良事件。在整个研究过程中监测HZ发病病例。在第二剂接种后一年，评估ARD患者和CG中HI和CI的持续性。分别使用抗gE抗体的血清浓度和gE特异性CD4+T细胞的频率评估HI和CI。使用双向重复测量方差分析分析ARD患者和CG在不同时间点的抗gE滴度比较。将进行多元回归分析，以阳性免疫反应作为因变量，将单变量分析中p<0.2的变量作为自变量。
这项大型试验通过研究疾病安全性、疗效、不良反应和免疫原性，填补了一个关键空白，同时考虑了重组带状疱疹疫苗接种后不同治疗方法对ARD患者的影响。
