不同剂量重组乙型肝炎疫苗(CHO细胞)采用两种免疫接种程序的对照研究

Case-controlled Study on Two Versus Three Doses of HBV Vaccine

目的了解在青少年中不同剂量重组乙型肝炎疫苗（CHO细胞）采用两针或三针免疫接种程序接种后,乙肝病毒表面抗体的应答,为制定青少年乙肝疫苗免疫策略提供依据。方法将岳阳市湘阴县246名11~15岁学生随机分为四组,采用10μg（CHO细胞）和20μg（CHO细胞）乙肝疫苗按照0、3或0、1、6两种不同的免疫程序进行接种,首针免疫后的第7个月检测血清抗-HBs阳转率和抗-HBs平均几何滴度（GMT）,同时观察不良反应。结果 10μg,0、3接种组（Ⅰ组）、10μg,0、1、6接种组（Ⅱ组）、20μg,0、1、6接种组（Ⅲ组）、20μg,0、3接种组（Ⅳ组）抗-HBs阳转率分别为71.9%、94.8%、94.1%和96.8%,Ⅱ、Ⅲ、Ⅳ组抗-HBs阳转率显著高于Ⅰ组（P〈0.05）;血清抗-HBs平均几何滴度（GMT）,Ⅰ、Ⅱ组显著低于Ⅲ、Ⅳ组（P〈0.05）,而Ⅲ、Ⅳ组之间比较差异无统计学意义（P〉0.05）。结论在青少年（11~15岁）人群中,采用20μg大剂量的乙肝疫苗接种后能获得较高抗体阳转率和平均几何滴度,且两针法能达到三针法同样的效果,完全可能取代低剂量三针接种,达到一样的免疫效果,值得推广。

Objective To explore the response rate of HBsAb in different dose groups of recombinant hepatitis B vaccine after two or three injections immunization programs,and to provide the evidence for making the strategy of hepatitis B vaccine for teenagers. Methods Totally 246 students aged between 11 and 15 years in Xiangyin County were randomly divided into 4 groups,then 10 ug and 20 ug CHO cell hepatitis B vaccines were used according to 0,3 or 0,1,6 immunization programs.The positive shifting rate of HBsAb in serum and GMT were tested in the 7th month after the first immunization,and the complication was observed simultaneously. Results The positive shifting rate of HBsAb in 10 ug,0,3 immunization group（group I）,10 ug,0,1,6 immunization group（group II）,20 ug,0,1,6 immunization group（group III）,and 20 ug,0,3 immunization group（group IV） were 71.9%,94.8%,94.1% and 96.8%,respectively.The positive shifting rates of HBsAb of groups II,III,IV were significantly higher than that of group I（P〈0.05）.GMTs in groups I,II were significantly lower than those of groups III,IV（P〈0.05）,but no statistically significant difference was found between group III and group IV（P〉0.05）. Conclusions For teenagers aged between 11 and 15 years,20 ug,large dose hepatitis B vaccine shows a higher positive shifting rate of HBsAb and GMT after immunization,and moreover,the two-dose program has similar effect as the 3-dose one.The results suggest that the 2-large-dose program can replace the 3-low-dose one,it is worth popularizing.