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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 detecting the immunogenicity of Hib-CRM197 conjugate vaccine in rabbits. Methods Hib-CRM197 conjugate vaccine was injected into the armpit of rabbits subcutaneously at a dose of 12.5μg polysaccharides per dose for 1, 7 and 14 days, respectively. At the same time, a negative control group (normal saline) and a positive control Group (3 manufacturers of similar products on the market). Blood samples were taken from the rabbit ear auricle artery before the last immunization. Serum was collected from rabbit hearts within 1-2 weeks after the last immunization. Serum antibody levels were detected by ELISA. Results The serum A_ (490) values of Hib-CRM197-conjugated vaccine group and positive control group were all higher than 5 times of the value of pre-immune A 490 and more than twice as high as that of cutoff. Conclusion It is feasible to test the immunogenicity of Hib-CRM197 conjugate vaccine by the rabbit method.