【摘要】 目的观察国产麻腮风联合减毒活疫苗(MMR)的安全性及免疫原性。方法选择8～15月龄未接种过麻疹、腮腺炎、风疹疫苗的健康儿童共765名,随机分别接种上海生物制品研究所生产的麻疹、腮腺炎(高滴度)、风疹联合减毒活疫苗(沪高MMR)和麻疹、腮腺炎(低滴度)、风疹联合减毒活疫苗(沪低MMR)及国产对照MMR疫苗,观察接种后的安全性及免疫原性。采用ELISA法检测血清中的麻疹、腮腺炎、风疹的IgG抗体水平。结果 765名观察对象全身反应率为18.95%,局部反应率低于0.4%。3组疫苗免疫后麻疹抗体阳转率分别为97.34%、97.18%和95.04%,腮腺炎抗体阳转率分别为94.68%、89.83%和76.60%,风疹抗体阳转率分别为94.68%、94.35%和91.49%。3组疫苗免疫后麻疹抗体几何平均浓度(GMC)分别为6 221.57、5 766.34和5 054.75 mIU/ml,抗体平均增长约200倍;腮腺炎抗体GMC分别为381.33、308.46和207.01 U/ml,抗体平均增长分别约26、22和17倍;风疹抗体GMC分别为81.77、77.61和81.49 IU/ml,抗体平均增长约23倍。各组间麻疹和风疹抗体阳转率、GMC和平均增长倍数差异均无统计学意义(P>0.05),腮腺炎沪高、低MMR与对照MMR疫苗差异均有统计学意义(P<0.05),但沪高、低MMR疫苗间差异无统计学意义(P>0.05)。结论 3种MMR疫苗的安全性良好,免疫原性麻疹和风疹相似,腮腺炎存在差异,抗体阳转率上海生物制品研究所生产的高滴度腮腺炎MMR疫苗与低滴度腮腺炎MMR疫苗差异无统计学意义。更多还原

【Abstract】 Objective To observe the safety and immunogenicity of domestic combined live attenuated measles,mumps and rubella(MMR) vaccine.Methods A total of 765 healthy children unimmunized with MMR previously,aged 8 ~ 15 months,were randomly divided into HG,HD and control groups and immunized with MMR vaccines with high and low mumps virus titers manufactured by Shanghai Institute of Biological Products and domestic MMR vaccine as control respectively,then observed for safety and immunogenicity.The IgG levels against measles,mumps and rubella in sera of the children were determined by ELISA.Results The systemic and local adverse reaction rates of the 765 immunized children were 18.95% and less than 0.4% respectively.The positive conversion rates of antibody against measles in HG,HD and control groups were 97.34%,97.18% and 95.04%,while those against mumps were 94.68%,89.83% and 76.60%,and those against rubella were 94.68%,94.35% and 91.49%,respectively.The geometric mean concentrations(GMCs) of antibody against measles in the three groups were 6 221.57,5 766.34 and 5 056.75 mIU/ml respectively,which increased by about 200 folds in average;while those against mumps were 381.33,308.46 and 207.01 U/ml,which increased by about 26,22 and 17 folds in average respectively;and those against rubella were 81.77,77.61 and 81.49 IU/ml respectively,which increased by about 23 folds in average.No significant differences were observed in the positive conversion rates,GMCs as well as their mean increasing folds of antibodies against measles and rubella in various groups(P > 0.05).However,the indexes were significantly higher in HG and HD groups than in control group(P < 0.05),while showed no significant differences in HG and HD groups(P > 0.05).Conclusion All the three kinds of MMR vaccines showed high safety,of which the immunogenicity to measles and rubella were similar while those to mumps showed significant difference.However,the antibody positive conversion rates induced by high and low titer MMR vaccines manufactured by Shanghai Institute of Biological Products showed no significant difference.更多还原