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本文评价了牛-人轮状病毒重组株WI79-9作为口服减毒活疫苗的可能性。作者用Gl型人轮状病毒WI79中编码轮状病毒主要外壳蛋白VP7的基因片段与牛轮状病毒WC3(G6型)的其余基因片段进行重组得到WI79-9病毒;采用双盲安慰剂对照法进行研究给2~6月龄婴儿口服2剂疫苗,间隔时间为1个月,评价疫苗的安全性、免疫原性和保护效力。 研究在三个私立儿科诊所进行。疫苗每剂2.5ml,含有用无菌Eagle最低必需培养基(MEM)和樱桃糖浆稀释的10~(7.5)空斑形成单位(PFU)WI79-9病毒;2.5ml安慰剂仅含MEM和樱桃糖浆。婴儿先口服30ml豆浆(含400mg NaHCO_3),再服用疫苗或安慰剂。服苗前至少1小时停止哺乳。在服苗前和末次服苗后28天采血,用微量中和法检测轮状病毒中和抗体。有15名婴儿口服安慰剂,16名婴儿口服疫苗。两组婴儿的年龄中位数相似。 结果表明,疫苗耐受性良好,服苗组和对照组在接种后10天内发生不良反应(低热)的人数相似。在服苗组中93%的婴儿的Gl型WI79-9疫苗病毒中和抗体滴度有4倍以上增
This article evaluated the potential of the bovine-human rotavirus recombinant WI79-9 as a live attenuated oral vaccine. The authors obtained the WI79-9 virus by recombining the gene fragment encoding the major coat protein VP7 of rotavirus with the rest of the gene fragment of the bovine rotavirus WC3 (G6 type) in the Gl type human rotavirus WI79; the double-blind placebo-controlled method Study 2 to 6-month-old infants oral administration of two doses of vaccine, the interval was 1 month, evaluate the safety of the vaccine, immunogenicity and protection effectiveness. The study was conducted in three private pediatric clinics. The vaccine, 2.5 ml per dose, contains 10 to 7.5 plaque forming units (PFU) WI79-9 virus diluted in sterile Eagle Minimum Essential Medium (MEM) and cherry syrup; 2.5 ml placebo contains only MEM and cherry syrup . Infants first oral 30ml soy milk (containing 400mg NaHCO_3), and then taking a vaccine or placebo. At least 1 hour before breast-feeding stopped feeding. Blood samples were taken 28 days before and after the last serving of the vaccine, and neutralizing antibodies against rotavirus were detected by micro-neutralization. 15 infants took placebo and 16 infants took oral vaccine. The median age of infants in both groups was similar. The results showed that the vaccines were well tolerated, with similar numbers of adverse reactions (hypothermia) in the vaccine groups and control groups within 10 days of vaccination. 93% of infants in the service-taking group had a 4-fold more neutralizing antibody titer of the WI-7979 vaccine virus