国产冻干麻疹腮腺炎风疹联合减毒活疫苗的接种反应和免疫原性观察

目的观察冻干麻疹腮腺炎风疹联合减毒活疫苗的接种反应和免疫原性。方法分Ⅰ、Ⅱ、Ⅲ期进行,分别选择7～15岁和8～18月龄儿童接种国产MMR疫苗,同时设进口MMR疫苗、单价麻疹、腮腺炎、风疹疫苗对照,进行接种反应和免疫原性观察。结果Ⅰ期7～15岁接种国产MMR疫苗的11人中,仅3人发生局部弱反应,反应率为27.3%;8～11月龄接种国产MMR疫苗的26人中,发热率和皮疹反应率分别为11.5%、15.4%,其中高热率为3.8%。Ⅱ、Ⅲ期观察的1188名8～18月龄儿童中,接种国产MMR疫苗发热率为10.69%,皮疹反应率为3.64%,局部反应率为0.44%,其他反应率为0.22%。与对照疫苗比较,仅发热率高于腮腺炎疫苗及风疹疫苗,且差异有统计学意义,其他反应差异均无统计学意义。接种国产MMR疫苗后,麻疹、腮腺炎、风疹HI抗体阳转率和抗体GMT分别为99.5%、85.9%、100%和1∶57、1∶4.2、1∶890。与对照疫苗比较,麻疹抗体GMT国产MMR疫苗高于进口MMR疫苗和麻疹疫苗,抗体阳转率国产MMR疫苗高于进口MMR疫苗,且差异有统计学意义;腮腺炎抗体GMT国产MMR疫苗低于进口MMR疫苗,且差异有统计学意义,其他各疫苗组差异均无统计学意义。结论国产MMR疫苗具有良好的安全性和免疫原性。

Adverse Reaction and Immunogenicity Induced by Domestic Freeze-dried Live Attenuated Measles-Mumps-Rubella Combined Vaccine

Objective To observe the adverse reaction and immunogenicity induced by domestic freeze- dried live attenuated measles-mumps-rubella(MMR) combined vaccine. Methods Perform clinical trials of phases Ⅰ, Ⅱ and Ⅲ on domestic live attenuated MMR vaccine in children aged 7 ～ 15 years and infants aged 8-18 months respectively, using imported MMR vaccine as well as domestic monovalent measles vaccine, mumps vaccine and rubella vaccine as control. Results In clinical trial phase Ⅰ, mild local reactions were observed in only 3 (27. 3%) of 11 children at ages of 7 ～ 15 years after inoculation with domestic MMR vaccine. In the 26 infants inoculated with domestic MMR vaccine, at ages of 8 ～ 11 months, the incidences of fever, rash and high fever were 11. 5%, 15. 4% and 3. 8% respectively. However, in 1188 infants aged 8 ～ 18 months in clinical trials phases Ⅱ and Ⅲ, the incidences of fever, rash, local reaction and other reactions after inoculation with domestic MMR vaccine were 10. 69%, 3. 64%, 0. 44% and 0. 22% respectively. The incidence of fever after inoculation with domestic MMR vaccine was significantly higher than those with mumps vaccine and with rubella vaccine. However, the incidences of other adverse reactions after inoculation with domes- tic MMR vaccine showed no significant difference with those with control vaccines. The positive rates of HI antibodies against measles, mumps and rubella induced by domestic MMR vaccine were 99. 5%, 85. 9% and 100%, while the antibody GMTs were 1 ∶ 57, 1 ∶ 4. 2 and 1 ∶ 890 respectively. The GMT of antibody against measles induced by domestic MMR vaccine was significantly higher than those by imported MMR vaccine and by measles vaccine. However, the GMT of antibody against mumps induced by do- mestic MMR vaccine was significantly lower than that by imported MMR vaccine. Conclusion The domestic MMR vaccine showed good safety and immunogenicity.