III期多国研究(ZOE-50/70)表明,佐剂化重组带状疱疹疫苗(RZV)在50岁以上的健康人群中具有良好的耐受性并可预防带状疱疹(HZ)。各年龄组的疫苗效力(VE)>90%。这些关键的试验没有招募来自中国大陆的参与者,因此,该人群缺少类似的临床数据。在2021年至2023年在中国进行的第四期观察者盲研究(NCT04869982)中,免疫功能正常且医学稳定的≥50岁人群以1:1随机分配接受两种RZV或安慰剂剂量,相隔两个月。这项研究评估了VE(总体而言,作为确认目标,并按年龄类别描述[50-69岁/≥70岁]),反应原性,以及RZV在中国人群中的安全性。在6138名注册参与者中,99.2%完成了研究。在平均15.2(±1.1)个月的随访期间,确认了31HZ发作(RZV=0;安慰剂=31),发生率为每1000人年0.0vs8.2,总体VE为100%(89.82-100)。描述性VE为50-69岁的100%(85.29-100),≥70岁的100%(60.90-100)。与安慰剂组相比,RZV组的诱发不良事件(AE)更频繁(中位持续时间:两组均为1-3天)。疼痛和疲劳是最常见的局部和一般AE(RZV:72.1%和43.4%;安慰剂:9.2%和5.3%)。未经请求的AE的频率,严重的AE,潜在的免疫介导的疾病,两组的死亡情况相似.RZV在中国≥50岁人群中具有良好的耐受性和有效预防HZ,与包括具有相似年龄和医学特征的全球人群的疗效研究一致。
背景是什么?带状疱疹,通常被称为带状疱疹,是由引起水痘的休眠病毒重新激活引起的疼痛皮疹。预防带状疱疹的疫苗,比如Shingrix,在来自欧洲的50岁以上的健康成年人中显示出良好的耐受性和有效性,北美和拉丁美洲,澳大利亚,和亚洲(台湾,香港,韩国,日本)。然而,有关Shingrix的现实世界保护作用的数据在某些疫苗被许可使用的地区有限,比如中国大陆。我们分析了50岁或以上中国成年人的数据,以确定Shingrix的疗效和安全性。大约6000名参与者被分成两组,接受两剂Shingrix或两剂安慰剂,相隔两个月。我们发现,在学习期间,该疫苗在预防带状疱疹方面100%有效。我们表明该疫苗在中国人群中具有可接受的安全性。影响是什么?Shingrix在50岁以上的中国成年人中有效且耐受性良好,与其他评估地区的类似老年人群一样。
Phase III multi-country studies (ZOE-50/70) demonstrated that the adjuvanted recombinant zoster vaccine (RZV) was well tolerated and prevented herpes zoster (HZ) in healthy ≥ 50-year-olds, with a vaccine efficacy (VE) > 90% across age groups. These pivotal trials did not enroll participants from mainland
China where RZV is licensed, therefore similar clinical data are missing for this population. In this phase IV observer-blind study (NCT04869982) conducted between 2021 and 2023 in
China, immunocompetent and medically stable ≥ 50-year-olds were randomized 1:1 to receive two RZV or placebo doses, 2 months apart. This study assessed the VE (overall, as confirmatory objective, and descriptively by age category [50-69-year-olds/≥ 70-year-olds]), reactogenicity, and safety of RZV in this Chinese population. Of the 6138 enrolled participants, 99.2% completed the study. During a mean follow-up period of 15.2 (±1.1) months, 31 HZ episodes were confirmed (RZV = 0; placebo = 31) for an incidence rate of 0.0 vs 8.2 per 1000 person-years and an overall VE of 100% (89.82-100). The descriptive VE was 100% (85.29-100) for 50-69-year-olds and 100% (60.90-100) for ≥ 70-year-olds. Solicited adverse events (AEs) were more frequent in the RZV vs the placebo group (median duration: 1-3 days for both groups). Pain and fatigue were the most frequent local and general AEs (RZV: 72.1% and 43.4%; placebo: 9.2% and 5.3%). The frequencies of unsolicited AEs, serious AEs, potential immune-mediated diseases, and deaths were similar between both groups. RZV is well tolerated and efficacious in preventing HZ in Chinese ≥ 50-year-olds, consistent with efficacy studies including worldwide populations with similar age and medical characteristics.
What is the context? Herpes zoster, commonly known as shingles, is a painful rash resulting from the reactivation of the dormant virus causing chickenpox.Vaccines preventing shingles, such as Shingrix, were shown to be well tolerated and efficacious in healthy adults over 50 years of age from Europe, North and Latin America, Australia, and Asia (Taiwan, Hong Kong, Korea, Japan).However, data on real-world protective effect of Shingrix are limited in some regions where the vaccine is licensed for use, such as mainland China.What is new? We analyzed data from Chinese adults aged 50 years or older to determine the efficacy and safety of Shingrix.Around 6000 participants were divided in two equal groups to receive two doses of Shingrix or two doses of a placebo, given 2 months apart.We found that, during the study period, the vaccine was 100% efficacious in preventing shingles.We showed that the vaccine had an acceptable safety profile in this Chinese population.What is the impact? Shingrix is efficacious and well tolerated in Chinese adults over 50 years of age, as it is in similarly aged populations from other evaluated regions.