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目的比较国产及进口重组乙型肝炎(乙肝)疫苗(酵母)[Hepatitis B Vaccine(HepB)Made by Recombinant Deoxyribonucleic Acid Techniques in Yeast]的小鼠体内效力差异。方法选取一定批数的国产及进口HepB-酿酒酵母(Saccharomyces Cerevisiae Yeast,SCY)和HepB-汉逊酵母(Hansenula Polymorph Yeast,HPY),采用1.25微克/毫升(μg/ml)、0.31μg/ml、0.08μg/ml三个稀释度,进行小鼠体内效力测定,使用微粒子化学发光免疫分析法(Chemiluminescence Microparticle Immunoassay,CMIA)测定抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs),对不同疫苗的50%有效剂量(50%Effective Dose,ED50)及Anti-HBs几何平均浓度(Geometric Mean Concentration,GMC)进行比较。结果在SCY表达的HepB比较中,国产疫苗B在ED50及AntiHBs GMC方面均优于其他两家疫苗;在HPY表达的HepB比较中,国产疫苗C的ED50低于其他两家疫苗,进口疫苗的Anti-HBs GMC显著高于国产疫苗。结论部分国产HepB的效力已经达到甚至超过进口疫苗的水平。
AIM To compare the in vivo efficacy of domestic and imported mice vaccinated with recombinant Hepatitis B Vaccine (HepB) Made by Recombinant Deoxyribonucleic Acid Techniques in Yeast. Methods A batch of domestic and imported HepB-Saccharomyces cerevisiae (Yeast, SCY) and HepB-Hansenula Polymorph Yeast (HPY) 0.08 μg / ml in three dilutions to determine the in vivo potency of the mice, and the Antibody to Hepatitis B Virus Surface Antigen (Anti-HBs) was measured using a Chemiluminescence Microparticle Immunoassay (CMIA) , 50% Effective Dose (ED50) and Geometric Mean Concentration (GMC) of different vaccines were compared. Results Compared with HepB in SCY, domestic vaccine B was superior to the other two vaccines in ED50 and AntiHBs GMC. In HPY-expressing HepB, ED50 of domestic vaccine C was lower than that of the other two vaccines, -HBs GMC was significantly higher than the domestic vaccine. Conclusion The efficacy of some domestic HepB has reached or even exceeded the level of imported vaccines.