人轮状病毒减毒活疫苗株89-12是从患者的粪便中分离、经原代非洲绿猴肾(AGMK)细胞传33代而得。试验对象为健康成人、轮状病毒血清阳性的2～12岁儿童和6～26周龄婴儿,所有试验均为随机、双盲,并设安慰剂对照组。在初步研究中,成人或血清阳性儿童接受1剂105蚀斑形成单位(pfu)疫苗或安慰剂,然后给9名6～26周龄婴儿接种1剂104pfu疫苗或安慰剂。最后随机给42名婴儿接种2剂105pfu疫苗或安慰剂,间隔6～10周。 Human rotavirus live attenuated vaccine strain 89-12 is isolated from the patient’s stool and is derived 33 passages on primary African green monkey kidney (AGMK). Subjects were healthy adults, rotavirus seropositive children 2 to 12 years and infants 6 to 26 weeks of age. All trials were randomized, double-blind, and placebo-controlled. In a preliminary study, adult or seropositive children received either one dose of 105 plaque-forming units (pfu) vaccine or placebo and then nine infants 6 to 26 weeks of age were vaccinated with one dose of 104 pfu vaccine or placebo. Finally, 42 infants were randomized to two doses of 105 pfu vaccine or placebo at intervals of 6 to 10 weeks.