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目的客观地评价北京市现行不同乙型肝炎(乙肝)疫苗的免疫效果。方法选择既往无乙肝疫苗接种史的大学生及出生时全程免疫过的儿童,检测血清HBsAg、抗-HBs及抗-HBc,全阴性者作为观察对象。入选人学生280人,按照0、1、6个月程序进行3针基础免疫,其中接种重组酿酒酵母乙肝疫苗(10μg、5μg、5μg)140人,重组汉逊酵母乙肝疫苗(10μg、10μg、10μg)140人。入选儿童98人进行1针加强免疫,其中酿酒酵母疫苗49人(5μg),汉逊酵母疫苗49人(10μg)。免疫后1个月采血检测抗-HBs。结果大学生3针免疫后,抗-HBs有效阳转率(≥10 mIU／ml)酿酒酵母疫苗低于汉逊酵母疫苗(93．5％,99．3%,P<0 05),几何平均滴度(GMT)二者差异无统计学意义(81．2 mIU／ml,94 6 mIU／ml,P>0．05)。从男性看,接种酿酒酵母疫苗的抗体有效阳转率及GMT均低于汉逊酵母疫苗(85．7％,100.0％,P<0.01)(56．6 mIU／ml,98.6 mIU／ml,P<0.01),而对于女性,差异均无统计学意义(98.8％,98．5％,P>0．05)(103.4 mIU／ml,90．3 mIU／ml,P>0.05)。从同种疫苗不同性别看,接种酿酒酵母疫苗抗体有效阳转率及GMT男性均低于女性(85．7％,98．8％, P<0．01)(56．6 mIU／ml,103.4 mIU／ml,P<0．01),而汉逊酵母疫苗男女性差异均无统计学意义(100．0％,98．5％,P>0.05)(98．6 mIU／ml,90．3 mIU/ml,P>0．05)。出生时按程序免疫的儿童,其抗-HBs阳性率随年龄增长呈下降趋势(P<0．01)。70例阴转者经1针加强免疫后,98．6％出现阳转, GMT显著提高到免疫前的15倍。阳转率及GMT 2种疫苗差异无统计学意义(100．0％,97．4％, P>0．05)(80．5 mIU／ml,68.5 mIU／ml,P>0．05)。结论乙肝疫苗的接种效果与疫苗种类及受种者性别均有关系。成人基础免疫,按目前常规使用剂量,男性接种汉逊酵母疫苗效果优于酿酒酵母疫苗,女性2种疫苗效果均好。儿童加强免疫,2种疫苗效果均较理想。重组疫苗初免后抗体阴转者的免疫记忆良好,新生儿完成重组乙肝疫苗全程免疫后至少6年之内无需加强。
Objective To objectively evaluate the immune effect of different hepatitis B (hepatitis B) vaccines in Beijing. Methods Select the past history of hepatitis B vaccination of university students and children immunized during birth, detection of serum HBsAg, anti-HBs and anti-HBc, all negative as the observation object. A total of 280 students were enrolled. According to the 0,1,6-month program, 3-needle-based immunizations were carried out, of which 140 were inoculated with recombinant Saccharomyces cerevisiae Hepatitis B vaccine (10μg, 5μg and 5μg), and Hansenula HB vaccine (10μg, 10μg and 10μg 140 people. Forty-eight children were enrolled in a one-dose booster immunization, of which 49 were Saccharomyces cerevisiae (5 μg) and 49 were Hansenula (10 μg). One month after the immunization, blood was collected to detect anti-HBs. Results After 3-needle immunization, the effective anti-HBs positive rate (≥10 mIU / ml) of S. cerevisiae vaccine was lower than that of Hansenula polymorpha vaccine (93.5%, 99.3%, P <0.05) There was no significant difference between the two groups (81.2 mIU / ml, 94 6 mIU / ml, P> 0.05). From the male perspective, the effective positive rate and GMT of vaccinated Saccharomyces cerevisiae vaccine were lower than that of Hansenula vaccine (85.7%, 100.0%, P <0.01) (56.6 mIU / ml, 98.6 mIU / ml, P (P <0.05) (103.4 mIU / ml, 90.3 mIU / ml, P> 0.05). However, there was no significant difference between the two groups (P> 0.05). In terms of different genders of the same vaccines, the effective positive rate of immunization and GMT vaccination of S. cerevisiae vaccines were lower than those of women (85.7%, 98.8%, P <0.01) (56.6 mIU / ml, 103.4 mU / ml, P <0.01), while there was no significant difference between male and female Hansenula vaccines (100.0%, 98.5%, P> 0.05) mIU / ml, P> 0.05). Children born at program immunization showed a trend of decline in anti-HBs positive rate with age (P <0.01). After 70 cases of negative conversion by 1-pin boost, 98.6% of positive conversion, GMT significantly increased to 15 times before immunization. There was no significant difference between the two vaccines (100.0%, 97.4%, P> 0.05) (80.5 mIU / ml, 68.5 mIU / ml, P> 0.05). Conclusion The vaccination effect of hepatitis B vaccine is related to the type of vaccine and the sex of the recipient. Adult basic immunity, according to the current routine use of doses, male vaccination Hansenula is superior to Saccharomyces cerevisiae vaccine, the effect of the two vaccines are good. Children to strengthen immunity, the two vaccines are more satisfactory results. After immunization, the immune memory of the antibody-negative people after the initial immunization of the recombinant vaccine is good, and the newborn need not be strengthened within at least 6 years after the complete immunization of the recombinant hepatitis B virus is completed.