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目的评价一种国产人用狂犬病疫苗(Vero细胞)用于10~60岁健康人群的免疫原性和安全性。方法单中心、随机、双盲、同类制品平行对照、模拟暴露后免疫的非劣效性研究。采用“Essen”免疫程序,选择10~60岁健康人群,按照1∶1比例随机接种试验疫苗和对照疫苗,使用日记卡收集每针次接种后不良反应情况。采集免前、首针免后第14天和第42天血液标本,用快速荧光灶抑制试验(RFFIT)检测血清中狂犬病毒中和抗体水平。结果试验组和对照组各入组600人。首针免后第42天和第14天,抗体阳转率均达到100%;抗体几何平均浓度(GMC)试验组为13.00IU/ml和7.89IU/ml,对照组为15.03IU/ml和10.20IU/ml,差异有统计学意义。总体征集性不良反应发生率试验组和对照组分别为60.33%和65.67%,差异无统计学意义。总体全身不良反应发生率对照组(46.17%)高于试验组(39.83%),前3针次不良反应发生率对照组(25.17%、16.13%、27.97%)均高于试验组(17.83%、11.80%、22.24%),差异有统计学意义。结论长春卫尔赛生物药业有限公司研制的人用狂犬病疫苗(Vero细胞)在10~60岁健康人群中具有较好的免疫原性和安全性。
Objective To evaluate the immunogenicity and safety of a domestic rabies vaccine for humans (Vero cells) for healthy people aged 10-60 years. Methods A single-center, randomized, double-blind, parallel-controlled study of similar preparations was used to simulate the non-inferiority of post-exposure immunization. The “Essen” immunization program was used to select 10 to 60-year-old healthy people. Randomly inoculate the test vaccine and the control vaccine according to the ratio of 1: 1, and use the diary card to collect the adverse reactions after each inoculation. Blood samples were collected on the 14th and 42nd postnatal day before and after the first injection, and the level of rabies virus neutralizing antibody in serum was detected by the Rapid Focal Inhibition Test (RFFIT). Results The trial group and the control group each enrolled 600. The positive rate of antibody positive rate reached 100% on the 42nd and the 14th day after the first injection. The antibody geometric mean concentration (GMC) test group was 13.00 IU / ml and 7.89 IU / ml, while the control group was 15.03 IU / ml and 10.20 IU / ml, the difference was statistically significant. The overall incidence of adverse reactions recruited test group and control group were 60.33% and 65.67%, the difference was not statistically significant. The overall incidence of systemic adverse reactions in the control group (46.17%) was higher than that in the test group (39.83%). The incidences of the first 3 adverse reactions were higher in the control group (25.17%, 16.13%, 27.97% 11.80%, 22.24%), the difference was statistically significant. Conclusion The human rabies vaccine (Vero cells) developed by Changchun Wiersai Bio-Pharmaceutical Co., Ltd. has good immunogenicity and safety in healthy people aged 10-60 years.