不同代次毒种冻干风疹减毒活疫苗的临床反应及免疫原性观察

目的　观察风疹BRDⅡ 3 0、3 1和 3 2代次毒种的免疫原性和反应原性。方法　选择风疹血清HI抗体阴性儿童 2 77名和女青年 141名 ,各随机分 3组 ,分别接种由 3 0、3 1和 3 2代毒种制备的风疹疫苗 ,观察接种反应及血清学效果。结果　儿童组的血清中HI抗体阳转率分别为 97.8%、98.9%和 98.9% ;GMT分别为 2 78.7、2 3 7.1和 2 92 .9,女青年组HI抗体阳转率分别为 94.8%、97.5 %和 10 0 .0 % ;GMT分别为 10 1.5、13 2 .9和 96.6。 3批疫苗间免后HI抗体阳转率和GMT差异无显著意义。结论　风疹毒种从 3 0～ 3 2代间的生物学特性是稳定的 ,均可用于疫苗的生产。

Reaction and Immunogenicity of Freeze-dried Live Attenuated Rubella Vaccine Prepared with Virus Strain at Different Passages

Objective To study the reactinogenicity and immunogenicity of rubella virus strain BRD Ⅱ at the 30 th ,31 st and 32 nd passages.Methods The reactinogenicity and immunogenicity were observed in 277 children and 141 young women,both negative in serum rubella HI antibody.The children,or women,were divided into 3 groups and inoculated with the rubella vaccine prepared with strain BRD Ⅱ at the 30 th ,31 st and 32 nd passages respectively.Results The serum rubella HI antibody positive conversion rates of 3 groups of children were 97.8%,98.9% and 98.9%,and the GMTs of them were 278.7,23.7.1 and 292.9 respectively.However,in the 3 groups of young women,the positive conversion rates were 94.8%,97.5% and 100.0%,and GMTs were 101.5,132.9 and 96.6 respectively.No significant difference were observed in the HI antibody positive conversion rates or GMTs induced by the vaccine prepared with the 3 passages of virus.Conclusion The biological characters of rubella virus strain at passages 30 to 32 are stable.All the passages can be used for the production.