成人接种重组(酿酒酵母)乙肝疫苗和重组(汉逊酵母)乙肝疫苗后效果观察

2012年4月第2卷第8期·临床研究·成人接种重组（酿酒酵母）乙肝疫苗和

重组（汉逊酵母）乙肝疫苗后效果观察

孙迎春 朱丽君 张 智 高冬梅 董桂华

沈阳市疾病预防控制中心免疫规划科，辽宁沈阳 110031

[摘要] 目的观察重组（酿酒酵母）乙肝疫苗和重组（汉逊酵母）乙肝疫苗在成人中的免疫效果。 方法对HBsAg、抗HBs、抗HBc三项指标全部为阴性、且未接种过乙肝疫苗的162名16岁以上人群，按照0、1、6的免疫程序接种10μg重组（酿酒酵母）乙肝疫苗和重组（汉逊酵母）乙肝疫苗，于全程免疫1个月后采血，测定血清中抗HBs水平。 结果 接种重组（酿酒酵母）乙肝疫苗的99人，抗HBs阳转率为94.95%，几何平均浓度为331.08 mIU/mL；接种重组（汉逊酵母）乙肝疫苗的63人，抗HBs阳转率为98.41%，几何平均浓度为270.79 mIU/mL。两组间抗HBs阳转率和几何平均浓度差异均无统计学意义（P＞0.05）。接种两种疫苗均未观察到明显的不良反应。 结论 重组（酿酒酵母）乙肝疫苗和重组（汉逊酵母）乙肝疫苗均具有良好的安全性和免疫原性。

[关键词]重组（酿酒酵母）乙肝疫苗；重组（汉逊酵母）乙肝疫苗；免疫效果

[中图分类号] R4；R512.6+2 [文献标识码] B [文章编号] 2095-0616（2012）08-169-02

Evaluation on Immunization Effectivity of Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae) and Recombinant Hepatitis B Vaccine (Hansenula Polymorpha) in adults

SUN Yingchun ZHU Lijun ZHANG Zhi GAO Dongmei DONG Guihua

Department of Gynaecology and Obstetrics, Shenyang Center for Disease Control and Prevention,Shenyang 110031,China

[Abstract] Objective To observe and compare the immunization effectivity of recombinant hepatitis B vaccine (Saccharomyces cerevisiae) and recombinant hepatitis B vaccine (Hansenula Polymorpha) in adults. Methods Randomly selected 162 healthy subjects aged over 16 years old. They have no a history of hepatitis B vaccine immunization and their HBsAg, antiHBs and antiHBc were all negative. They were vaccinated with 10μg of recombinant hepatitis B vaccine (Saccharomyces cerevisiae) and recombinant hepatitis B vaccine (Hansenula Polymorpha) at 0, 1, 6 months. After a month in completing the 3rd vaccination, their serum samples were collected and antiHBs was detected. Results 99 people were slected to vaccinate recombinant hepatitis B vaccine (Saccharomyces cerevisiae). The positive seroconversion rate of antiHBs was

94.95%. The geometric mean concentration of antiHBs was 331.08 mIU/mL; 63 people were slected to vaccinate recombinant

hepatitis B vaccine (Hansenula Polymorpha). The positive seroconversion rate of anti-HBs was 98.41%. The GMC of anti-HBs was 270.79 mIU/mL. The statistical significance of differences were not found in the positive seroconversion rates and the GMCs between two groups (P＞0.05). All the vaccines did not show any severe adverse effect. Conclusion Both recombinant hepatitis B vaccine (Saccharomyces cerevisiae) and recombinant hepatitis B vaccine (Hansenula Polymorpha) are very effective and safe to adults.

[Key words] Recombinant hepatitis B vaccine (saccharomyces cerevisiae); Recombinant hepatitis B vaccine (hansenula polymorpha); Immune effect

乙型病毒性肝炎（简称乙肝）是一种严重威胁人类健康的传染病，接种乙肝疫苗是预防和控制乙肝最有效的手段，目前使用较多的乙肝疫苗为重组（酿酒酵母）乙肝疫苗。重组（汉逊酵母）乙肝疫苗于2004年在中国上市，经过多年的观察研究，两种疫苗在儿童中使用的安全性和免疫原性已得到了肯定[1-3]。为比较重组（酿酒酵母）乙肝疫苗和重组（汉逊酵母）乙肝疫苗在成人中的免疫效果，笔者选择了162名健康成年人进行了观察，现报道如下。1 资料与方法

1.1 一般资料

选择沈阳市沈北新区未接种过乙肝疫苗，经筛检HBsAg、抗HBs、抗HBc三项指标全部为阴性，无乙肝病史，无乙肝疫苗接种禁忌证的162人为研究对象，年龄16～58。随机分为两组：接种重组（酿酒酵母）乙肝疫苗组99例，重组（汉逊酵母）乙肝疫苗组63例。

1.2 乙肝疫苗来源

重组（酿酒酵母）乙肝疫苗为深圳康泰生物制品股份有

CHINA MEDICINE AND PHARMACY 169