国产冻干麻疹-流行性腮腺炎-风疹联合减毒活疫苗免疫原性及安全性观察

目的观察国产冻干麻疹-流行性腮腺炎(腮腺炎)-风疹联合减毒活疫苗(MMR)的安全性及免疫原性。方法选取18~24月龄儿童210名,每名儿童接种1剂MMR,在接种后30min、6h、24h、48h、72h、7d、9d分别观察接种后临床反应,并于接种前、后6周各采集血清标本1份,用血凝抑制(HI)试验定量检测麻疹、腮腺炎、风疹IgG抗体。结果接种MMR后中、弱发热反应发生率4.29%,在1~2d内消退,无异常反应发生。免疫前麻疹HI抗体阴性儿童,免疫后抗体阳转率100%;免疫前麻疹HI抗体阳性儿童,免疫后抗体≥4倍增长率61.53%;抗体几何平均滴度(GMT)免疫后比免疫前增长3.8倍。免疫前腮腺炎HI抗体阴性儿童,免疫后抗体阳转率83.50%;免疫前腮腺炎HI抗体阳性儿童,免疫后抗体≥4倍增长率53.97%;抗体GMT免疫前1∶1.57,免疫后1∶3.52。免疫前风疹HI抗体均为阴性,免疫后抗体阳转率100%;抗体GMT 1∶487.2。免疫前、后麻疹、腮腺炎、风疹的抗体阳转率及GMT差异均有显著的统计学意义。结论国产冻干MMR具有良好的安全性和免疫原性。

Inspection on Security and Immunity Effect of Homemade Lyophilized Measles,Mumps and Rubella Live Vaccine

Objective To observe the security and immunity effect of Homemade Lyophilized Measles,Mumps and Rubella Live Vaccine.Method Among inoculated 210 children of 18-24 months,observed the vice-reactions of each children in 30 m,6 h,24 h,48 h,72 h,7 d and 9 d after inoculating vaccine,and collected serum specimen of 6th week to detect Measles,Mumps,and Rubella IgG antibody with H_1 TestHemagglutination Inhibition Test).Results After inoculating,the occurrence rate of general vice reaction was 4.29%,fading away within 1-2 days.Among the children who had no Measles H_1 antibody before inoculating,the turning positive rates of Measles H_1 antibody was 100%,while among the children having its quadrupled growth rate was 61.53%,with antibody GMT growth of 380%.Among the children who had no Mumps H_1 antibody before,its quadrupled growth rate was 53.97%,with post-inoculating antibody GMT level of 3.52 relative to pre-inoculating level of 1.57.At the same time,among the children who had no Rubella H_1 antibody before inoculating,the quadrupled growth rates of the Rubella antibody was 100% with antibody GMT level of 487.2.The turning positive rates of Measles,Mumps,and Rubella antibody between pre-inoculating and post-inoculating were significantly different.Conclusion The homemade lyophilized Measles,Mumps,and Rubella Live Vaccine has favorable effect in its security and immunity.