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麻疹减毒活疫苗沪191株主种子批毒种安全性和免疫原性观察
引用本文:张淑君,;肖奇友,;李放军,;魏至栋,;刘溯,;张祺,;邓注红,;黄乐,;傅汝林,;方捍华.麻疹减毒活疫苗沪191株主种子批毒种安全性和免疫原性观察[J].中国计划免疫,2009(5):423-425.
作者姓名:张淑君  ;肖奇友  ;李放军  ;魏至栋  ;刘溯  ;张祺  ;邓注红  ;黄乐  ;傅汝林  ;方捍华
作者单位:[1]湖南省疾病预防控制中心,长沙110005; [2]兰州生物制品研究所,甘肃兰州730046; [3]平江县疾病预防控制中心,湖南平江410400; [4]中国药品生物制品检定所,北京100050
摘    要:目的评价新制备的麻疹减毒活疫苗(Measles Attenuated Live Vaccine,MV)沪191株主种子批毒种原疫苗的安全性和免疫原性。方法根据入选和排除标准,选择8~10月龄无麻疹病史、MV接种史和疫苗接种禁忌证的健康儿童,接种用沪191株主种子批毒种制备的MV0.5ml,于接种后30min、6h、24h、48h、72h、7d、14d、21d、28d观察局部和全身反应;并采集免疫前和免疫后28d血清,采用红血球凝集抑制(Hemagglutination Inhibition,HI)试验检测麻疹病毒抗体阳转率和几何平均滴度(Geometric Mean Titer,GMT)。结果受种者未见严重不良反应,免疫后28d血清中麻疹病毒HI抗体阳转率为100%,麻疹病毒抗体GMT为1:50.66。结论新制备的MV沪191株主种子批毒种疫苗,在适龄儿童中具有良好的安全性和免疫原性。

关 键 词:麻疹减毒活疫苗  沪191株主种子批毒种  安全性  免疫原性  红血球凝集抑制试验

Safety and Immunogenicity of Measles Attenuated Live Vaccine Prepared by Master Seed Lot Vaccine of Shanghai-191 Strain
Institution:ZHANG Shu-jun, XIAO Qi-you, LI Fang-jun, et al. (Hunan Provincial Center for Disease Control and Prevention, Changsha 410005, Hunan, China)
Abstract:Objective To evaluate the safety and immunogenicity of a new measles vaccine prepared by master seed lot original vaccine of Shanghai-191 strain. Methods According to selection and exclusion criteria, 8-10-month healthy children, who have no history of measles, measles vaccine inoculation and vaccination contraindication were selected. The children selected were vaccinated 0.5ml measles attenuate live vaccine prepared by master seed lot vaccine of the Shanghai- 191 strain. They were observed the local and systemic response in 30min and 6h, 24h, 48h,72h, 7d, 14d, 21d, 28d after inoculation, and immune serum were collected before immunization and after 28 days. Measles virus antibody positive rate and geometric mean titer (GMT) were detected by hemagglutination inhibition. Results There were not serious adverse reactions. Measles virus antibodies in serum positive rate was 100% after 28 days of immunization, and measles virus antibody GMT was 1:50.66. Conclusion New measles vaccine prepared by master seed lot original vaccine of the Shanghai- 191 strain at 8-10-month children was safe and immunogenicity.
Keywords:Measles attenuated live vaccine  Master seed lot vaccine of the Shanghai -191 strain  Safety  Immunogenicity  Hemagglutination inhibition test method
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