20微克重组乙型肝炎疫苗对成人免疫安全性的研究  

Research on immunological safety of 20 micrograms dose of recombinant hepatitis B vaccine in adults

作　　者：王萍[1] 李艳萍[2] 韦琳[1] 农艺[2] 谢昌平[1] 杨兵华[1] 蓝剑[1] 

机构地区：[1]广西壮族自治区柳州市疾病预防控制中心,545007 [2]广西壮族自治区疾病预防控制中心

出　　处：《职业与健康》2013年第14期1712-1717,共6页Occupation and Health

基　　金：柳州市科学技术局计划课题"成人剂型20μg重组乙型肝炎疫苗(汉逊酵母)免疫原性和安全性研究"(项目编号:2011J030204);广西壮族自治区卫生厅自筹经费科研课题"成人剂型20μg重组乙型肝炎疫苗(汉逊酵母)免疫原性和安全性研究"(项目编号:Z2011268)

摘　　要：目的观察不同剂量重组乙肝疫苗(汉逊酵母)对成人的安全性。方法选择无乙肝疫苗接种史和疫苗接种禁忌证,实验室筛检乙型肝炎标志物HBsAg、抗-HBs及抗-HBc均阴性、丙氨酸转氨酶正常,年龄为15岁以上的在校学生1 600人作为观察对象。采用随机、双盲、对照原则,将入选的观察对象分为试验组和对照组,各800人,以0-1-6月全程接种方案,分别接种20μg重组乙肝疫苗(汉逊酵母)和10μg重组乙肝疫苗(汉逊酵母),受试者在免疫前、全程接种后第4周采集静脉血以检测血清抗-HBs,进行免疫原性评价。结果试验组和对照组分别观察到463和437例不良反应,反应率57.88%和54.63%,中度以上反应率9.25%和8.25%。局部反应率为42.50%和36.007%,2级以上局部反应率为5.00%和3.25%。全身反应率为37.38%和35.50%,2级以上全身反应率为4.63%和5.63%。试验组和对照组总反应率、全身不良反应率和2级以上局部反应率差异无统计学意义,局部反应症状主要为疼痛和发红,全身反应症状主要为发热,未收集到与疫苗接种相关的严重不良反应。20μg重组乙肝疫苗是安全的,并可诱导较高的乙肝抗体应答。结论 20μg重组乙肝疫苗(汉逊酵母)具有10μg重组乙肝疫苗相同的安全性,显示加大疫苗剂量后未增加不良反应的发生率,但免疫应答优于10μg重组乙肝疫苗。[ Objective]To observe the safety of different doses of recombinant hepatitis B vaccine （Hansenula polymorpha） in a- dults. [ Methods] 1600 students who were over 15 years old, without hepatitis B vaccination history and contraindications to vacci- nation, were selected as the object of observation, while all of their hepatitis B markers, including HBsAg, anti-HBs and anti-HBc, were negative by laboratory screening, as well as ALT level were normal. By using random, double blind and the control principle, the students were divided into the experiment group and the control group, 800 people in each group. According to 0,1,6 months schedule, the experiment group was given 20 p^g of recombinant hepatitis B vaccine （ Hansenula polymorpha） and the control group was given 10 p.g of recombinant hepatitis B vaccine （ Hansenula polymorpha）. The venous blood samples were collected before im- munization and the 4th weeks after whole course vaccination, to evaluate the immunogenieity by serum anti-HBs detection. [ Results] There were 463 and 437 cases of adverse reactions in the experimental group and the control group, which the incidence rate was 57.88% and 54.63% respectively. The incidence rate of moderate and over adverse reactions was 9.25% and 8.25% re- spectively. The incidence rate of local reactions was 42.50% and 36. 007% respectively, while the rate of local reactions over Grade 2 was 5.00% and 3.25% respectively. The incidence rate of general reactions was 37.38% and 35.50% respectively, while the rate of general reactions over Grade 2 was 4.63% and 5.63% respectively. There was no significant difference in total in- cidence rate of adverse reactions, incidence rate of general reactions and incidence rate of local reactions over Grade 2 between two groups. The main local adverse reactions included pain and redness, and the general reaction was mainly fever. The severe adverse reactions related to vaccination were not reported. 20 micrograms dose of recombinant hepatitis B vaccine was safe, and it can

关 键 词：重组乙肝疫苗 随机对照临床试验 安全性 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]