Clark H F, Offit P A, Ellis R W, Krah D, Shaw A R, Eiden J J, Pichichero M, Treanor J J
Department of Pediatrics, University of Pennsylvania, Philadelphia, USA.
Arch Virol Suppl. 1996;12:187-98. doi: 10.1007/978-3-7091-6553-9_20.
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.
第12代传代水平的牛轮状病毒毒株WC3（P7[5]，G6）在婴儿中临床耐受性良好，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果并不一致，在四项独立试验中从76%到0%不等；在所有试验中都观察到了对严重疾病的一些选择性保护作用。含有个体人类轮状病毒VP7（G）或VP4（P）表面抗原基因的WC3重配株也具有良好的耐受性，但优先诱导针对WC3亲本的VNA。人类G1 VP7重配株WI79-9（P7[5]，G1）的有效性试验始终导致对所有轮状病毒疾病的保护率>60%。一种四价WC3重配疫苗被开发出来，它包含四个分别表达人类轮状病毒表面蛋白G1、G2、G3和P1A[8]的单价重配株。在一项包括439名婴儿的多中心试验中，这种疫苗对所有轮状病毒疾病的保护率为67.1%（仅通过ELISA检测轮状病毒抗原呈阳性来定义[p = <0.001]），当轮状病毒诊断标准为通过ELISA检测粪便中轮状病毒抗原和通过电泳图谱分析检测轮状病毒RNA均呈阳性时，保护率为72.6%（p = <0.001）。在该试验中，最严重的轮状病毒疾病发作（临床严重程度评分>16.0，共8例）仅发生在安慰剂接受者中。
