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目的评价流行性乙型脑炎(乙脑)纯化灭活疫苗(地鼠肾细胞)[Purified Inactivited Japanese Encephalitis Vaccine(Primary Hamster Kidney Cell),JEV-I(PHK)]接种安全性及血清学效果。方法共选择943名6月龄～10岁儿童进行Ⅰ、Ⅱ、Ⅲ期临床研究,临床研究用疫苗为兰州生物制品研究所研制,批号20010401,剂量为0.5ml/剂,每剂蛋白含量11.5μg。上臂三角肌肌内注射,0、7d各接种1剂。结果接种人体后副反应轻微,无严重全身及局部反应。共接种1848剂次,101剂次出现发热反应,其中98剂次≤37.5℃,24～72h自行恢复。Ⅰ期接种40人,总反应率2.5%;Ⅱ、Ⅲ期接种903人。另设对照疫苗组JEV-I(Vero细胞)接种101人,总反应率分别为6.2%和14.2%。血清学效果测定表明,在试验组与对照组,免疫前抗体阴性组的抗体阳转率分别为96.9%和84.0%,抗体几何平均滴度(Geometric Mean Titer,GMT)分别为1∶32.8和1∶43.9;免疫前抗体阳性组的抗体≥4倍增长率分别为93.1%和100.0%,抗体GMT分别为1∶167.2和1∶181.0。结论JEV-I(PHK)安全性和血清学效果良好。临床试验注册国家食品药品监督管理局《新药临床研究批件》(批件号2003L00429)。
Objective To evaluate the safety and serological effects of Purified Inactivated Japanese Encephalitis Vaccine (Primary Hamster Kidney Cell), JEV-I (PHK)] inactivated inactivated Japanese encephalitis (JE) vaccine. Methods A total of 943 children aged 6 months to 10 years were selected for clinical study Ⅰ, Ⅱ and Ⅲ. The vaccine for clinical research was developed by Lanzhou Institute of Biological Products with a batch number of 20010401, a dosage of 0.5ml / dose and a protein content of 11.5μg . Upper arm deltoid muscle injection, 0,7 d of each vaccination. The results after inoculation of human minor side effects, no serious systemic and local reactions. A total of 1848 doses of seeding, 101 doses of fever appeared, of which 98 doses ≤ 37.5 ℃, 24 ~ 72h self-recovery. Stage I inoculation 40 people, the overall response rate of 2.5%; Ⅱ, Ⅲ phase inoculation 903 people. Another control vaccine group JEV-I (Vero cells) vaccinated 101 people, the overall response rates were 6.2% and 14.2%. The results of serological tests showed that the positive rate of antibody positive in the group of negative antibody before immunization was 96.9% and 84.0% respectively in the test group and the control group, and the Geometric Mean Titer (GMT) of antibody was 1:32.8 and 1 : 43.9; the antibody of pre-immune antibody group had a ≥4-fold increase rate of 93.1% and 100.0% respectively, and the antibody GMT was 1:167.2 and 1:181.0 respectively. Conclusion The safety and serological efficacy of JEV-I (PHK) are good. Clinical trial registration State Food and Drug Administration “New Drug Clinical Research Approval” (approval number 2003L00429).