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目的评价不同种类国产基因重组乙型肝炎(乙肝)疫苗在不同人群中的免疫原性。方法采用血清流行病学调查方法,对不同种类国产基因重组乙肝疫苗的免疫原性进行评价。结果大学生接种不同种类国产基因重组乙肝疫苗后,乙肝病毒表面抗体阳性率为91.60%～98.72%,平均95.50%。大连汉信生物制药有限公司生产的重组乙肝疫苗(汉逊酵母)(大连疫苗)的抗体阳性率高于深圳康泰生物制品有限公司生产的重组乙肝疫苗(酵母)(康泰疫苗),四种疫苗[大连疫苗、康泰疫苗、北京天坛生物制品有限公司生产的重组乙肝疫苗(酵母)(天坛疫苗)、华北制药集团金坦生物制药有限公司生产的重组乙肝疫苗(中国仓鼠卵巢细胞)(华北疫苗)]免疫后,抗体几何平均浓度(GMC)差异有显著的统计学意义(F=36.54,P<0.05),即华北疫苗和大连疫苗免疫后抗体GMC均高于天坛疫苗和康泰疫苗,并且华北疫苗免疫后抗体GMC还高于大连疫苗。儿童乙肝疫苗加强免疫后抗体阳转率为96.60%～100.00%,平均98.31%,且加强免疫后抗体GMC差异无显著的统计学意义。结论不同种类国产基因重组乙肝疫苗应用在不同人群均能获得较好的免疫原性。成人在大剂量乙肝疫苗全程接种后,能获得较高的抗体阳转率和GMC。完成乙肝疫苗基础免疫、但抗体消失的儿童,小剂量加强免疫1针后也能获得较高的抗体阳转率和GMC,儿童体内存在良好的免疫记忆反应,一般不需要加强接种。
Objective To evaluate the immunogenicity of different types of domestic recombinant hepatitis B vaccine in different populations. Methods The serological epidemiological survey method was used to evaluate the immunogenicity of different types of domestic recombinant hepatitis B vaccine. Results The positive rate of HBsAg was 91.60% ~ 98.72% with an average of 95.50% after inoculation of different kinds of domestic recombinant hepatitis B vaccine. The positive rate of recombinant hepatitis B vaccine (Hansenula polymorpha) (Dalian vaccine) produced by Dalian Hanson Biological Pharmaceutical Co., Ltd. was higher than that of the recombinant hepatitis B vaccine (Kangtai vaccine) produced by Shenzhen Kangtai Biological Products Co., Ltd. [ Recombinant Hepatitis B Vaccine (Tiantan Vaccine) Produced by Beijing Tiantan Biological Products Co., Ltd., Recombinant Hepatitis B Vaccine (Chinese Hamster Ovary Cell) (North China Vaccine) Produced by North China Pharmaceutical Group Kintan Bio-Pharmaceutical Co., Ltd.] After immunization, there was a significant difference in antibody mean geometric concentration (GMC) (F = 36.54, P <0.05), that is, GMC of North China and Dalian vaccines were higher than that of Tiantan and Kangtai vaccines, Antibody GMC is still higher than the Dalian vaccine. The antibody positive rate after immunization with hepatitis B vaccine was 96.60% -100.00%, with an average of 98.31%. There was no significant difference in antibody GMC between the two groups. Conclusion Different types of domestic recombinant hepatitis B vaccine can be used in different populations to obtain better immunogenicity. Adult high-dose hepatitis B vaccine inoculation, can get higher antibody positive rate and GMC. Complete basic hepatitis B vaccine immunization, but the disappearance of antibodies in children, a small dose of enhanced immune 1 needle can get higher antibody positive conversion rate and GMC, children have good immune memory in vivo response, generally do not need to step up vaccination.