WC3 reassortant vaccines in children.
WC3 reassortant vaccines in children.
复制标题
儿童 WC3 重配疫苗。
DOI：
10.1007/978-3-7091-6553-9_20
复制
发表时间：
1996
期刊：
影响因子：
--
通讯作者：
Treanor,JJ
中科院分区：
文献类型：
--
作者：
Clark,HF;Offit,PA;Ellis,RW;Krah,D;Shaw,AR;Eiden,JJ;Pichichero,M;Treanor,JJ
牛轮状病毒WC3 （P7[5], G6）在婴儿临床耐受良好，并能有效诱导具有牛轮状病毒G6特异性的血清病毒中和抗体（VNA）。WC3疫苗对所有轮状病毒疾病的保护效力不一致，在四项独立试验中从76%到0%不等；在所有的试验中都看到了一些针对严重疾病的选择性保护。含有单个人轮状病毒VP7 (G)或VP4 (P)表面抗原基因的WC3重组体也具有良好的耐受性，但优先诱导VNA进入WC3亲本。人类G1 VP7重组WI79-9 （P7[5], G1）的疗效试验一致显示>对所有轮状病毒疾病的保护作用为60%。研制了一种四价WC3重组疫苗，其中包含四种分别表达人轮状病毒表面蛋白G1、G2、G3和P1A[8]的单价重组。在一项包括439名婴儿的多中心试验中，该疫苗对所有轮状病毒疾病（定义为仅通过ELISA检测轮状病毒抗原阳性[p= <0.001]）的保护率为67.1%，当轮状病毒诊断的标准是通过ELISA检测轮状病毒抗原和通过电泳分析轮状病毒RNA检测轮状病毒阳性时（p = <0.001），该疫苗的保护率为72.6%。在这项试验中，最严重的轮状病毒疾病发作（临床严重程度评分bbbb16.0, 8例）仅发生在安慰剂接受者中。
Bovine rotavirus strain WC3 (P7[5], G6) administered at the 12th passage level was well tolerated clinically in infants and efficiently induced serum virus neutralizing antibody (VNA) with bovine rotavirus G6 specificity. The protective efficacy of WC3 vaccine against all rotavirus disease was inconsistent, varying in four separate trials from 76% to 0%; some selective protection against severe disease was seen in all trials. WC3 reassortants containing the gene for an individual human rotavirus VP7 (G) or VP4 (P) surface antigen were also well tolerated, but preferentially induced VNA to the WC3 parent. Efficacy trials of human G1 VP7 reassortant WI79-9 (P7[5], G1) consistently led to >60% protection against all rotavirus disease. A quadrivalent WC3 reassortant vaccine was developed to contain four separate monovalent reassortants expressing human rotaviruses surface proteins G1, G2, G3, and P1A [8] respectively. In a multicenter trial including 439 infants, this vaccine induced 67.1% protection against all rotavirus disease (defined as positive for rotavirus antigen by ELISA only [p= <0.001]) and 72.6% protection when the standard for rotavirus diagnosis was a positive test of stool for both rotavirus antigen by ELISA and rotavirus RNA by electropherotype analysis (p = < 0.001). In this trial, episodes of the most severe rotavirus disease (clinical severity score > 16.0, eight cases) occurred only in placebo recipients.