口服轮状病毒活疫苗安全性和免疫原性观察

为了观察口服轮状病毒活疫苗在儿童服用后的安全性和免疫原性效果。于惠州市选择63名6月龄~3岁的儿童为观察对象。所用疫苗由兰州生物制品研究所生产,服苗前和服苗后4~5周采末梢血,以中和试验检测抗轮状病毒(G1、G2、G3、G4)型抗体及疫苗株(LLR型)的抗体水平。63名儿童服苗前、后采集的血清样本双份配对均有效者为37人。37人服苗后各型抗体阳转率为47.06%~72.72%;≥4倍增长率为43.40%~66.04%;各型中和抗体免疫前后平均增长2.67~3.01倍。63名服苗儿童中的不良反应为低热3例(24.67%)、中热1例(1.59%)、无高热反应。观察结果表明,轮状病毒具有良好的免疫原性和安全性。

Observation on safety and efficacy of oral rotavirus vaccine

63 children from 6 months to 3 years old in Huizhou, Guangdong province were administrated oral rotavirus vaccine produced by Lanzhou Institute of Biological Products. Blood samples were collected before vaccination and 4～5 weeks after vaccination. 37 sera in pair (serum before and after vaccination) were qualified after samples by screening. The antibodies of 37 sera in pair against rotavirus strain G1、G2、G3、G4 and LLR were determined by neutralization test. The positive seroconversion rates of antibodies against the various strains of rotavirus were 47.06%-72.72%. In comparison in between after and before vaccination, the rates of sera in pair for antibody increasing ≥4 times were 43.40%-66.04%. To each virus strain, after vaccination the average antibody increasing times of GMT was 2.67-3.01 folds than those of before vaccination. The rate of fever occurrence after vaccination was 6.35 % among 63 children. The results indicates that the vaccine does have of good safety and immunogenicity.