一项前瞻性、多中心上市后监测队列研究,以监测重组带状疱疹疫苗在中国≥50岁成年人中的安全性。
A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age.
作者信息
Pang Xinghuo, Spence O'Mareen, Parmar Neeraj, Wang Jing, Zhou Tao, Guo Xiang, Colliou Audrey, Pradeep Sarang Sheela, Yousefi Mitra, Yun Huifeng
机构信息
Department of Immunization, CDC, Beijing, China.
GSK, Rockville, USA.
出版信息
Hum Vaccin Immunother. 2024 Dec 31;20(1):2439031. doi: 10.1080/21645515.2024.2439031. Epub 2024 Dec 16.
This post-marketing surveillance study evaluated the safety of the adjuvanted recombinant zoster vaccine (RZV) in Chinese adults, given the limited country-specific safety data accumulated since the 2019 licensure of RZV in China for adults ≥ 50 years of age (YOA). This descriptive, prospective cohort study enrolled adults ≥ 50 YOA who voluntarily received RZV per routine clinical practice in six centers in China. The primary outcomes were occurrence, intensity, and causal relationship to vaccination of medically attended adverse events (MAEs) within 30 days post-any dose. The occurrence and causal relationship to RZV of serious AEs (SAEs) within 30 days post-any dose, and of SAEs and potential immune-mediated diseases (pIMDs) from dose 1 until 12 months post-last dose were secondary outcomes. The exposed set included 3,300 adults (mean age [standard deviation]: 61.2 [7.4] years; 67.1% female), of whom 3,175 completed the study. Fifty-six MAEs were recorded in 42 (1.3%, 95% confidence interval [CI]: 0.9-1.7%) participants; ≥1 grade 3 MAE was reported in six (0.2%, 0.1-0.4%) participants; 15 MAEs (in nine [0.3%, 0.1-0.5%] participants) were considered RZV-related. Within 30 days post-any dose, 12 SAEs were reported in 10 (0.3%, 0.1-0.6%) participants, while 29 SAEs in 22 (0.7%, 0.4-1.0%) participants were reported from post-dose 1 until 12 months post-last dose. The three reported fatal SAEs were not considered RZV-related. Three of the total seven pIMDs were considered RZV-related. The observed descriptive patterns of MAEs, SAEs, and pIMDs did not indicate safety concerns following RZV administration among Chinese adults ≥ 50 YOA.
鉴于自2019年重组带状疱疹疫苗(RZV)在中国获批用于50岁及以上成年人以来,特定国家积累的安全性数据有限,本上市后监测研究评估了该疫苗在中国成年人中的安全性。这项描述性前瞻性队列研究纳入了中国六个中心按照常规临床实践自愿接种RZV的50岁及以上成年人。主要结局是任何一剂接种后30天内发生的、有医疗记录的不良事件(MAE)的发生率、严重程度及其与疫苗接种的因果关系。任何一剂接种后30天内严重不良事件(SAE)的发生率及其与RZV的因果关系,以及从第1剂接种后至最后一剂接种后12个月内SAE和潜在免疫介导疾病(pIMD)的发生率为次要结局。暴露组包括3300名成年人(平均年龄[标准差]:61.2[7.4]岁;67.1%为女性),其中3175人完成了研究。42名(1.3%,95%置信区间[CI]:0.9 - 1.7%)参与者记录了56起MAE;6名(0.2%,0.1 - 0.4%)参与者报告了≥1起3级MAE;15起MAE(9名[0.3%,0.1 - 0.5%]参与者)被认为与RZV相关。任何一剂接种后30天内,10名(0.3%,0.1 - 0.6%)参与者报告了12起SAE,而从第1剂接种后至最后一剂接种后12个月内,22名(0.7%,0.4 - 1.0%)参与者报告了29起SAE。报告的3起致命SAE不被认为与RZV相关。7起pIMD中,3起被认为与RZV相关。观察到的MAE、SAE和pIMD的描述性模式并未表明50岁及以上中国成年人接种RZV后存在安全性问题。