新兵(学员)预防接种20μg重组乙型肝炎疫苗(酿酒酵母)的免疫效果分析  

Immune effect of 20μg dosages of recombinant hepatitis B vaccine derived Saccharomyces Cerevisiae Yest in recruits

作　　者：唐玥[1] 杨益[1] 孙走南[1] 李瑾慧 苏文莉[1] 张洁[1] 黄留玉[1] 常国辉[1] TANG Yue YANG Yi SUN Zou-Nan LI Jin-Hui SU Wen-Li ZHANG Jie HUANG Liu- Yu CHANG Guo-Hui(Institute of Disease Control and Prevention ,Academy of Military Medical Sciences, Beijing 100071, China)

机构地区：[1]军事医学科学院疾病预防控制所免疫规划中心,北京100071

出　　处：《中国免疫学杂志》2017年第3期356-359,364,共5页Chinese Journal of Immunology

基　　金：国家新药创制重大专项课题(2012ZX09J12106-01B)

摘　　要：目的:分析评价军队某部乙型肝炎表面抗体(Antibody to hepatitis B virus surface antigen,抗-HBs)阴性/弱阳性的新入伍人员,接种剂型为20μg/ml的酿酒酵母重组乙型肝炎疫苗(Recombinant hepatitis B vaccine derived Saccharomyces Cerevisiae Yest,Hep B-SCY)后的免疫效果。方法:利用酶联免疫吸附法(Enzyme-linked immunosorbent assay,ELISA)和放射免疫法(Radioimmunoassay,RIA),筛选抗-HBs为阴性的3 251名和弱阳性的1 090名新兵(学员)为实验观察对象,按照0、1和6的接种程序,接种20μg/ml剂型的Hep B-SCY,分别在每针接种后第28天采血,用化学粒子发光免疫分析法(Chemiluminescence immunoassay,CLIA)检测血清抗体的几何平均浓度(Geometric mean titer,GMT)。结果:观察对象全程免疫后,在弱阳性新兵(学员)中,第1、2和3针接种后阳转率分别为90.24%、97.82%和99.52%,第2针免疫后的阳转率明显优于1针免疫后阳转率(χ~2=25.65,P<0.01),而第2与3针免疫后的阳转率之间无统计学差异(χ~2=4.66,P>0.01);第1和第2针免疫后乙肝表面抗体的GMT值分别为1 575.92 m U/ml(374.94~4 606.45)和2 144.592 m U/ml(757.078~6 089.4),二者的GMT水平存在统计学差异(Z=-2.372,P<0.01)。在阴性人群中,第2和第3针接种后阳转率分别为86.13%和98.72%,其中,高应答反应阳转率分别为56.43%和87.53%,第3针免疫后的阳转率明显优于第2针(χ~2=118.5,P<0.05),第3针免疫后的高应答反应率也明显高于第2针(χ~2=231.07,P<0.05);第1、2和3针免疫后的GMT值分别为101.352 m U/ml(2.11~409.23)、155.812 m U/ml(26.76~840.78)和747.312 m U/ml(228.60~1893.6),第2和3针的GMT水平之间差异存在统计学意义(Z=-23.042,P<0.01),第1和2针的GMT水平之间差异也存在统计学意义(Z=-3.099,P<0.01)。结论:接种20μg/ml剂型的Hep B-SCY可激发机体产生较高水平的抗-HBs,并可有效提高群体的阳转率和高应答反应率。Objective： To evaluate the immune effect of 20 microgram dosages of recombinant hepatitis B vaccine derived Saccharomyces Cerevisiae Yest（ Hep B-SCY） in recruits. Methods： A total of 4 341 subjects whose antibody to hepatitis B virus surface antigen（ anti-HBs） was weak positive or negative tested by Enzyme-linked Immunosorbent Assay（ ELISA） and Radioimmunoassay（ RIA） were received a Hep B-SCY vaccine intramuscularly at 0,1,and 6 months. Anti-HBs concentrations were evaluated by a Chemiluminescence Immunoassay（ CLIA） at 28 days after every injection. Results： After the first,second and third dose,the 20 microgram dosages of Hep B-SCY increased the seroconversion（ anti-hepatitis B surface antigen） rate to 90. 24%,97. 82% and 99. 52% in weak positive recruits,respectively. There were significant differences between the second dose and the first one（ χ~2= 25. 65,P〈0. 01）,but there were no significant differences between the third dose and the second one（ χ~2= 4. 66,P〉0. 01）. Geometric mean titer（ GMT） of anti-hepatitis B surface antigen（ anti-HBs） were more than 1 575. 92 m U / ml（ 374. 94- 4 606. 45） after the first dose and up to2 144. 59 m U / ml（ 757. 078-6 089. 4） after the second dose in weak positive recruits,showing significant difference between them（ Z =-2. 372,P〈0. 01）. After the second dose and the third one,seroconversion rates in the negative recruits were 86. 13% and 98. 72%,respectively. And the high-responding seroconversion rates were 56. 43% and 87. 53%,respectively. Both of them indicating significant difference between the second dose and the third one（χ~2= 118. 5,P〈0. 05）,（χ~2= 231. 07,P〈0. 05）. The GMT in the negative recruits were 101. 35 m U / ml（ 2. 11-409. 23）,155. 81 m U / ml（26. 76-840. 78） and 747. 31 m U / ml（228. 60-1893. 6） after the first dose,the second and the third one,respectively. There were significant different between the second dose and the third one（Z =- 23. 042,P 〈0. 01）,the s

关 键 词：新兵(新学员) 重组乙肝疫苗 免疫效果 

分 类 号：R186.3[医药卫生—流行病学] R183.7[医药卫生—公共卫生与预防医学]