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目的观察国产麻疹腮腺炎风疹联合减毒活疫苗(MMR)对8月龄婴儿的安全性及免疫原性。方法选择8~9月龄未接种过麻疹、腮腺炎、风疹疫苗的健康儿童共77名,随机分别接种国产MMR疫苗40名和国产对照麻疹风疹减毒活疫苗(MR)37名,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 77名观察对象全身反应率为6.49%,未观察到局部反应。2组疫苗免疫后麻疹抗体阳转率均为100%,MMR组腮腺炎抗体阳转率为87.50%,风疹抗体阳转率分别为82.50%和86.49%。2组疫苗免疫后麻疹抗体平均浓度分别为1714.63、和1 117.54IU/ml,抗体平均增长约627.72和12 870.35倍;MMR组腮腺炎抗体平均浓度为3 313.81U/ml,抗体平均增长分别约24.32倍;风疹抗体平均浓度分别为40.63和44.22IU/ml,抗体平均增长分别约40.63和44.22倍。2组间麻疹和风疹抗体阳转率、抗体平均浓度和平均增长倍数差异均无统计学意义(P>0.05);麻疹、风疹抗体同时阳性率差异无统计学意义(P>0.05)。结论 MMR疫苗对8月龄婴儿的安全性、免疫原性良好且能提供额外的腮腺炎抗体。
Objective To observe the safety and immunogenicity of domestic measles mumps rubella combined live attenuated vaccine (MMR) in 8-month-old infants. Methods A total of 77 healthy children aged 8-9 months without measles, mumps and rubella vaccine were enrolled. 40 domestic MMR vaccine and 37 domestic measles rubella live attenuated vaccine (MR) were randomly inoculated and 37 Safety and immunogenicity. Serum IgG, mumps and rubella were detected by ELISA. Results The body reaction rate of 77 subjects was 6.49%. No local reaction was observed. The positive rate of measles antibody positive rate was 100% after immunization. The positive rate of mumps antibody in MMR group was 87.50%, and the positive rate of rubella antibody was 82.50% and 86.49% respectively. The average antibody levels of measles virus in the two groups of immunized mice were 1714.63 and 1 117.54IU / ml, respectively, with an average increase of about 627.72 and 12 870.35 times. The average mumps antibody in MMR group was 3 313.81U / ml and the average antibody level was about 24.32 Times; rubella antibody average concentrations were 40.63 and 44.22IU / ml, the average antibody growth were about 40.63 and 44.22 times, respectively. Measles and rubella antibody positive rate, average antibody concentration and average growth rate were not significantly different between the two groups (P> 0.05). There was no significant difference in measles and rubella antibody positive rates at the same time (P> 0.05). Conclusion The MMR vaccine is safe, immunogenic and provides additional mumps antibodies to infants aged 8 months.