幼兔法检测Hib-CRM 197结合疫苗免疫原性的可行性试验

Feasibility of determination of immunogenicity of Hib-CRM197 conjugate vaccine by immature rabbit method

目的评价幼兔法检测Hib-CRM197结合疫苗免疫原性的可行性。方法用Hib-CRM197结合疫苗经家兔腋窝处皮下注射,12.5μg多糖/(只·次),分别于0、7、14 d各免疫1次,同时设阴性对照组(生理盐水)及阳性对照组(3个厂家的市售同类产品)。免疫前经家兔耳缘动脉采血,末次免疫1~2周内经家兔心脏采血,分离血清,采用ELISA法检测家兔血清抗体水平。结果 Hib-CRM197结合疫苗组及阳性对照组家兔免疫后血清的A_(490)值均高于免疫前血清A_(490)值5倍以上,是cutoff值2倍以上。结论用幼兔法检测Hib-CRM197结合疫苗免疫原性是可行的。

Objective To evaluate the feasibility of determination of immnnogenicity of Hib-CRM197 conjugate vaccine by immature rabbit method. Methods Rabbits were injected s. c. with Hib-CRM197 conjugate vaccine at a dosage of 12. 5 μg polysaccharide on days 0, 7 and 14 respectively, using physiological saline as negative control and the comme- rcial products of the same kind from three manufacturers as positive control. Serum samples were collected before immunization and 1 - 2 weeks after the last immunization, and determined for antibody level by ELISA. Results The serum antibody levels （A490 values） of rabbits immunized with Hib-CRM197 vaccine and those in positive control group were more than 5 times higher than those before immunization, and more than 2 times higher than the cutoff value. Conclusion It is feasible to determine the immunogenicity of Hib-CRMI97 conjugate vaccine by immature rabbit method.