Fang Yuan, Chen Li, Liu Man-Qing, Zhu Zheng-Gang, Zhu Ze-Rong, Hu Quan
Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jianghan District Centers for Disease Control and Prevention, Wuhan, China.
PLoS Negl Trop Dis. 2014 Dec 18;8(12):e3412. doi: 10.1371/journal.pntd.0003412. eCollection 2014 Dec.
The aim of this study was to compare the safety and immunogenicity between purified vero cell rabies vaccine (PVRV) and purified chick embryo cell vaccine (PCECV) in patients with WHO category II animal exposure, especially in different age groups.
METHODOLOGY/PRINCIPAL FINDINGS: In one-year clinical observation after vaccination with PVRV or PCECV under Zagreb (2-1-1) or Essen (1-1-1-1-1) regimens, information collection for the demographic and adverse events (AEs) and rabies virus laboratory examination of neutralizing antibody (RVNA) titers were performed for all patients with WHO category II animal exposure in Wuhan city. The results showed no significant differences of safety and immunogenicity between PVRV and PCECV both in Zagreb and Essen regimens. However, when compared with other age groups, most systemic AEs (36/61) occurred in <5-year-old patients, and <5-year-old patients have significant lower RVNA titer and seroconversion rate (RVNA ≥0.5 IU/ml) at day 7 both in Zagreb and Essen regimens or PVRV and PCECV groups.
Our data showed that vaccination with PVRV is as safe and immunogenic as PCECV in patients of all age groups, but might be more popular for clinical use. When performing a vaccination with rabies vaccine in young children, the most optimal vaccine regimen should be selected.
本研究旨在比较纯化Vero细胞狂犬病疫苗(PVRV)和纯化鸡胚细胞疫苗(PCECV)在世界卫生组织(WHO)II级动物暴露患者中的安全性和免疫原性,尤其是在不同年龄组中的情况。
方法/主要发现:在按照萨格勒布(2-1-1)或埃森(1-1-1-1-1)方案接种PVRV或PCECV后的一年临床观察中,对武汉市所有WHO II级动物暴露患者进行了人口统计学和不良事件(AE)信息收集以及狂犬病病毒中和抗体(RVNA)滴度的实验室检测。结果显示,在萨格勒布和埃森方案中,PVRV和PCECV在安全性和免疫原性方面均无显著差异。然而,与其他年龄组相比,大多数全身不良事件(36/61)发生在<5岁的患者中,并且在萨格勒布和埃森方案以及PVRV和PCECV组中,<5岁患者在第7天的RVNA滴度和血清转化率(RVNA≥0.5 IU/ml)均显著较低。
我们的数据表明,PVRV接种在所有年龄组患者中与PCECV一样安全且具有免疫原性,但可能在临床应用中更受欢迎。在幼儿接种狂犬病疫苗时,应选择最优化的疫苗接种方案。