精制Vero细胞狂犬病疫苗的研制及免疫学效果观察

Studies on the manufacture and immunogenicity of purified rabies vaccines on humans Vero cell

目的 以Vero细胞为基质 ,研制新一代精制Vero细胞狂犬病疫苗。方法 以CTN 1V10为生产毒株 ,以 <15 0代Vero细胞为培养基质 ,采用转瓶旋转培养 ,按不同时间收获病毒液 ,经过澄清、浓缩、纯化、灭活制成精制Vero细胞狂犬病疫苗。从以此工艺制备的疫苗中选取一批做为免疫学效果观察的受试疫苗。按暴露后免疫程序接种 6 3人 ,其中受试疫苗接种 33人 ,法国维尔博狂犬病疫苗接种 30人 ,观察不良反应和测定中和抗体。结果 新研制的精制Vero细胞狂犬病疫苗各项指标完全符合WHO的有关质量要求。两种疫苗全程免疫后中和抗体阳转率均为 10 0 % ,中和抗体受试组为 11.94IU/ml;维尔博疫苗对照组为 11.6 9IU/ml。结论 精制Vero细胞狂犬病疫苗不但制造工艺合理 ,而且副反应轻微 。

Objective Using Vero cell as basic cultural material to improve the quality of rabies vaccines and to produce rabies vaccines for humans. Methods CTN 1V10 strain were used for prodaction. Vero cell of 150th generation were used for cultivation. Rotating cultivatal method with rotating bottle was used. Fluids with virus were collected at different time. Puritied rabies vaccine was produeed on Vero cell after clarification, condensation, purification and extermination. A batch of vaccines made by this techniques were used for immunological observation. Sixty three people were injected with this rabies vaccine according to the procedure of time of exposure. Thirty of them were injected with vaccines made in France (Verorab) while the others were injected with vaccines to be tested. Side effect and neutratizing antibody were recorded. Results The quality of this newly developed rabies vaccines has met the quality set by WHO. After all dosages of injection, the rates of positive antibody were both 100% in two groups. The neutralizing antibody among testing group was 11.94 IU/ml comparing with control as 11.69 IU/ml. Conclusion Purified rabies vaccines on Vero cell for humans had reasonable manufacture technique and less little effect with good technological imnunogenicity.