国产和进口重组乙型肝炎疫苗(酿酒酵母)在成人中的免疫效果及安全性的比较研究

Comparative study on immunization effect and safety of domestic and import recombinant hepatitis B vaccine(saccharomyces cerevisiae) in adults

目的比较成人接种20μg深圳康泰重组酿酒酵母乙肝疫苗和20μg葛兰素史克公司重组酿酒酵母乙肝疫苗接种后的免疫效果及接种后的不良反应。方法选择乙肝五项检查全阴者作为研究对象,随机分为两组,按照0-1-6月免疫程序接种乙肝疫苗,于30 d后采集静脉血,定量检测乙肝病毒表面抗体。比较不同种类乙肝疫苗免疫后的抗体应答率和抗体水平。结果无应答率、低应答率、正常应答率、高应答率康泰重组酿酒酵母乙肝疫苗分别为1.65%、1.65%、33.88%、62.82%;葛兰素史克重组酿酒酵母乙肝疫苗分别为4.23%、10.17%、18.64%、66.96%。两组间,4项指标无应答组、高应答组差异均无统计学意义(χ2=0.64、0.45,P>0.05)。低水平应答率和高水平应答率,两组间差异有统计学意义(χ2=8.015,P<0.05)。国产组和进口组几何平均浓度分别为630.74 m IU/ml和470.18 m IU/ml,差异无统计学意义(t=-1.17,P=0.25)。所有接种对象未发现明显的异常接种反应。结论20μg康泰重组酿酒酵母乙肝疫苗与20μg葛兰素史克重组酿酒酵母乙肝疫苗均有较好的免疫原性和安全性。

Objective To compare the immunization effect of and side effects induced by the inoculation of domestic and import recombinant hepatitis B vaccine(saccharomyces cerevisiae） among adults. Methods Healthy adults negative for HBs Ag,anti-HBs,HBe Ag,anti-HBe,and anti-HBc were divided into two groups randomly and were vaccinated following the schedule of0-1-6 month with 20 μg domestic and import Hep B-SYC. Questionare investigation was made and blood samples were collected for each person. Anti-HBs was detected by chemiluminescence microparticle immunoassay. Results There were 121 adults who received 20 μg Kangtai Hep B-SYC(domestic group） and 118 adults who received 20 μg Glaxo Smith Kline Hep B-SYC(import group）. In domestic group,the rate of non-low-normal-and high response were 1. 65%,1. 65%,33. 88%,62. 82% respectively. In import group,the corresponding rates were 4. 23%,10. 17%,18. 64%,66. 96% respectively. The rate of non-and high response didn＇ t show significant differences. No obvious adverse reactions were observed among the subjects between the two groups. The GMCs of anti-HBs were 630. 74 m IU/ml and 470. 18 m IU/ml. Conclusion The two kinds of hepatitis B vaccines have the same immunization effect and safety.