精制Vero细胞狂犬病疫苗的临床观察及免疫学效果研究

Studies on clinical trials and immune effect of a new purified rabies vaccine prepared from Vero cells

目的 目前我国使用的人用狂犬病疫苗生产工艺较落后 ,致使使用后副反应较严重 ,而国际上Vero细胞狂犬病疫苗已研制成功和使用近 2 0年 ,不仅免疫效果良好而且副反应很轻。为了改变我国狂犬病疫苗生产工艺的落后和质量较差的状况 ,而开展此项研究。方法 海南省生物制品研究所和河南省生物技术研究所联合研制的Vero细胞狂犬病疫苗获得卫生部批准进行临床观察 ,该疫苗以aG株适应Vero细胞后为生产毒种 ,转瓶培养、并浓缩适当倍数后经sepharoseFF 4B柱层析纯化后制备成疫苗。临床观察分两个阶段进行 ,第Ⅰ阶段接种 30人 ,第Ⅱ阶段接种 318人。结果 全部受试者仅显示 12 %的轻度副反应 ,无中强度副反应 ;不管以暴露前或暴露后方案接种 ,全程注射后的中和抗体阳转率均为 10 0 %。中和抗体GMI 2 89～ 5 2 9IU/ml。该疫苗经临床观察和中和抗体测定的结果显示 ,副反应轻微 ,且有良好的中和抗体应答。结论 精制Vero细胞狂犬病疫苗对人体安全且具有较好的免疫原性。

Objective To observe the safety and neutralizing antibody response of a new purified rabies vaccine prepared from Vero cells. Methods The vaccine used was manufactured in Hainan Institute of Biologicals and licensed by the Ministry of Health for clinical trials. The vaccine was administrated in 30 and 318 volunteers during phase Ⅰ and Ⅱ clinical trials with pre exposure (day 0, 7, and 28) or post exposure(day 0,3,7,14 and 28) vaccination schedules. The “Verorab(PVRV),” a rabies vaccine made in France was used as control.Results The results showed that the new purified vaccine did not cause any severe and moderate side reactions, the slight side reaction rate was 12% including those complained by vaccinees themselves. The immunological effect was determined by detecting neutralizing antibody with mouse neutralization test (NIH). The positive seroconversion rates of neutralizing antibody were 100% (n=27 GMT 2 89 IU/ml) and 100% (n=30, GMT 5 29 IU/ml) respectively by pre exposure and post exposure schedules. No significant difference was found when compared with France “Verorab” vaccine by pre exposure schedule (n=24, GMT 2 13 IU/ml). Conclusion The clinical trials indicated that the purified rabies vaccine prepared from Vero cells only showed slight side reaction and had good neutralizing antibody response. Therefore this new vaccine is safe and protective for prevention of rabies in human.