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为了解不同类型乙肝疫苗免疫学特性,提供选择生产路线的依据,对基因工程乙型肝炎疫苗的免疫原性和免疫效果进行了研究。实验结果表明:不同来源乙肝抗原结构不同,诱导的细胞免疫和体液免疫水平也有所不同。无糖基化的酿酒酵母抗原诱导Th1细胞反应能力强于其它种类糖基化抗原,对CHO疫苗进行去糖基化后,细胞免疫水平增强,与单克隆抗体反应的表位密度发生改变。在严格控制抗原量、孕妇的HBeAg水平和检测试剂等条件下,对518名免疫14批乙肝疫苗的新生儿进行母婴传播阻断研究,同时对2291名免疫21批乙肝疫苗的小学生进行1～7年的免疫观察,证明国产乙肝酵母疫苗母婴传播阻断保护率达到80.56％～92.59％,与国外酵母疫苗相同,5μg国产酵母疫苗虽然剂量小,诱导的抗体较低,但保护效果高于其他糖基化疫苗,与血源疫苗30μg相当,说明可能细胞免疫起主要作用。国产酵母疫苗抗体阳转率在免后5年时与Merck疫苗水平相当,但低于10μg Amgen和血源疫苗。建议尽早加强免疫。乙肝疫苗免疫失败与 HBV S抗原变异、孕妇 HBV DNA含量高等因素有关。
In order to understand the immunological characteristics of different types of hepatitis B vaccines and provide a basis for selecting production routes, the immunogenicity and immunological effects of genetically engineered hepatitis B vaccines were studied. The experimental results show that: different sources of hepatitis B antigen structure, induced cellular immunity and humoral immunity levels are also different. Glycosylation of Saccharomyces cerevisiae antigen induced Th1 cell response stronger than other types of glycosylated antigens. After deglycosylated CHO vaccine, the cellular immunity level was enhanced, and the epitope density reacted with the monoclonal antibody changed. In strict control of the amount of antigen, the level of HBeAg in pregnant women and test reagents and other conditions, 518 immunized 14 batches of hepatitis B vaccine for neonatal transmission of mother-to-child transmission, while 2191 immunized 21 batches of hepatitis B vaccine for 1 ~ Seven years of immunological observation showed that the protection rate of mother-to-infant transmission of domestic hepatitis B vaccine reached 80.56% ~ 92.59%. Similar to foreign yeast vaccines, the 5μg domestic yeast vaccine had a lower dose of induced yeast antibody but higher protective effect Other glycosylated vaccines, equivalent to 30 μg of the blood-borne vaccine, suggest possible cellular immunity plays a major role. The domestic yeast vaccine antibody positive rate was comparable to the Merck vaccine at 5 years post-vaccination, but was below 10 μg Amgen and the blood-borne vaccine. It is recommended to strengthen the immunization as soon as possible. Hepatitis B vaccine failure and HBV S antigen variation, high HBV DNA levels in pregnant women.