CAJ | 학술논문

目的为保证生产四价流脑(A、C、W135、Y群)结合疫苗质量一致性和可控性,对分离自国内的W135、Y群脑膜炎球菌CMCC(B)29037株和CMCC(B)29028株进行免疫原性及遗传稳定性观察.方法将W135/Y群脑膜炎球菌工作种子批菌种分别连续传代至30代,并收获3、5、10、15、20、25及30代次菌液,对各代次菌进行免疫原性、抗原性、生化反应、毒性、毒力测定,并将30代次菌发酵培养后提取荚膜多糖进行质量分析.结果 CMCC(B)29037株和CMCC(B)29028株工作种子批菌种诱导小鼠产生总IgG抗体分别为1∶1114和1∶2229,杀菌抗体水平与IgG抗体间差异无统计学意义;试管凝集效价均达到1∶320,生化检定两菌株均发酵葡萄糖、麦芽糖,不发酵果糖、蔗糖、甘露醇和乳糖;两菌株的LD50均＞109,30代次内各代次菌的免疫原性、抗原性、生化反应和毒性均无差异.30代次菌液脑腔毒性测定显示均无病理改变,用第30代次菌生产的W135/Y群脑膜炎球菌荚膜多糖各项检定指标均合格.结论分离自国内的CMCC(B)29037株和CMCC(B)29028株为脑膜炎球菌W135/Y群菌株,免疫原性、抗原性好,生化反应合格、安全性良好,连续传至30代次仍保持较好的安全性和免疫原性,30代次菌纯化的W135/Y群脑膜炎球菌荚膜多糖质量符合质控要求,可以用作四价流脑结合疫苗生产株.
목적 위보증생산사개류뇌(A、C、W135、Y군)결합역묘질량일치성화가공성,대분리자국내적W135、Y군뇌막염구균CMCC(B)29037주화CMCC(B)29028주진행면역원성급유전은정성관찰.방법 장W135/Y군뇌막염구균공작충자비균충분별련속전대지30대,병수획3、5、10、15、20、25급30대차균액,대각대차균진행면역원성、항원성、생화반응、독성、독력측정,병장30대차균발효배양후제취협막다당진행질량분석.결과 CMCC(B)29037주화CMCC(B)29028주공작충자비균충유도소서산생총IgG항체분별위1∶1114화1∶2229,살균항체수평여IgG항체간차이무통계학의의;시관응집효개균체도1∶320,생화검정량균주균발효포도당、맥아당,불발효과당、자당、감로순화유당;량균주적LD50균＞109,30대차내각대차균적면역원성、항원성、생화반응화독성균무차이.30대차균액뇌강독성측정현시균무병리개변,용제30대차균생산적W135/Y군뇌막염구균협막다당각항검정지표균합격.결론 분리자국내적CMCC(B)29037주화CMCC(B)29028주위뇌막염구균W135/Y군균주,면역원성、항원성호,생화반응합격、안전성량호,련속전지30대차잉보지교호적안전성화면역원성,30대차균순화적W135/Y군뇌막염구균협막다당질량부합질공요구,가이용작사개류뇌결합역묘생산주.
Objective To evaluate the immunogenic stability and hereditary stability of Neisseria meningitides serogroup W135/Y[CMCC(B)29037/CMCC(B)29028]within all the passages,which isolated from china.Methods The toxicity of the 3rd,5th,10th,15th,20th,25th and 30th passage of the Neisseria meningitidis was assayed in mice.Serological detection and biochemical detection were measured,and immunized mice subcutaneously.The antigeeicity of each passage of Neisseria meningitides serogroup W135/Y were measured by serum bactericidal test and the indirect ELISA.With the 30 passage of Neisseria meningitides serogroup W135/Y,the effect to the encephalic tissue was measured in mice.Fermented the Neisseria meningitides serogroup W135/Y with 30 passage and purified the capsular polysaccharide,then analyzed the quality respectively.Results The LD50 of the strains CMCC(B)29037/29028 of each passage was low(LD50 ≥ 109),and all the 30logical detection and all the 30 passage of the two strains were half in the tube agglutination.Glucose and maltose fermentation test were positive.Fructose,sucrose and lactose fermentation test were negative.The GMT of immunogenicity were 1114 and 2229 respectively and all the 30 passage were more than 640 and 1040 respectively.After Immunization with individual 30 passage of the Neisseria meningitides,the titer in serum bactericidal assay(SBA)and indirect ELISA were no difference.The capsular polysaccharide purified from Neisseria meningitides serogroup W135/Y met the quality standard.Conclusion Neisseria meningitides serogroup W135/Y,CMCC(B)29037/29028,used in the manufacture of the meningococcal conjugate vaccine,are stable in the toxicity,antigenicity,immunogenicity.Serological detection and biochemical detection are qulified,and the capsular polysaccharide has met the quality standard.