Yan Bingyu, Lyu Jingjing, Liu Jiaye, Feng Yi, Xu Aiqiang, Chen Shiyu, Zhou Libo, Liang Xiaofeng, Cui Fuqiang, Wang Fuzhen, Zhang Li
Division Expanded Program Immunization, Shandong Provincial Center for Disease Control and Prevention, Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Jinan 250014, China.
Email: ZL9127@163. com.
Zhonghua Yu Fang Yi Xue Za Zhi. 2014 Dec;48(12):1043-7.
To assess the 24-month efficacy after booster vaccination with 3 doses of hepatitis B vaccine among low-response adults in Zhangqiu county of Shandong province.
A total of 24 237 adults aged 18-49 years old, never received HepB vaccination, without HBV infection history, and had been living at 3 towns of Zhangqiu county in Shandong province for more than half a year in september, 2009, were collected blood samples of 3-5 ml. A total of 11 590 adults who were negative for hepatitis B virus (HBV) surface antigen (HBsAg) , antibody to HBsAg (Anti-HBs) and antibody to HBV core antigen (Anti-HBc), were divided into four groups randomly and were vaccinated following the schedule of 0-1-6 with 20 µg hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Saccharomyces cerevisiae (HepB-SC), 20 µg hepatitis B vaccine made by Chinese hamster ovary cell (HepB-CHO), 10 µg HepB-SC and 10 µg hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Hansenula Polymorpha (HepB-HP), respectively. The adults who were low-response to the primary hepatitis B vaccination (10 mU/ml ≤ anti-HBs<100 mU/ml) were divided into four groups by cluster random sampling. These groups were revaccinated with 3-dose of above-mentioned four kinds of HepB respectively. Blood samples were drawn from 1 month (T1) and 24 month (T24) after the 3 dose revaccination, respectively. Anti-HBs and anti-HBc was detected by Chemiluminescence Microparticle Imunoassay (CMIA).
Out of the 8 592 adults who have accepted the primary vaccination of hepatitis B and been collected the blood samples, 1 306 subjects showed low-response. A total of 718 low-response subjects were collected blood samples after T1 and T24 following 3 doses of booster vaccination. The proportion of the four groups was 32.3% (232/718), 25.8% (185/718) , 19.3% (139/718) , 22.6% (162/718) , respectively. The average proportion of anti-HBs ≥ 100 mIU/ml were decreased from 77.58% after T1 to 35.63% after T24 (χ² = 256.87, P < 0.01). The proportion of anti-HBs ≥ 100 mIU/ml in T24 were 38.8% (90/177), 39.5% (73/185), 25.2% (35/139) and 35.8% (58/162) in four groups, respectively. The proportion of anti-HBs>100 mIU/ml in T24 was significantly different among groups (χ² = 8.81, P = 0.032). The average geometric mean concentration (GMC) was significantly reduced from 443.53 mIU/ml after T1 to 48.98 mIU/ml after T24 (F = 439.41, P < 0.01). The GMC was 60.26 (45.71-77.62), 1.29 (38.90-69.18) , 35.48 (25.70-48.98) and 46.77 (33.88-6.07) mIU/ml in four groups, respectively (F = 1.97, P = 0.117) . Compared with vaccinated 20 µg HepB-SC, the proportion of anti-HBs ≥ 100 mIU/ml and GMC was 0.56 (0.35-0.91) and -0.20 (-0.39--0.02) times. The positive of HBsAg was not found and the positive rate of anti-HBc was 2.6% (18/692) in T24.
Protective antibody following booster vaccination with three doses of hepatitis B vaccines among low-response adults after 2 years fade faster. Antibody level of anti-HBs in T24 was corrected with the booster vaccine type and age. 20 µgHepB-SC seemed better than 10 µg HepB-SC.
评估山东省章丘市低应答成人接种3剂乙肝疫苗后的24个月疗效。
收集2009年9月共24237名年龄在18 - 49岁、从未接种过乙肝疫苗、无乙肝病毒感染史且在山东省章丘市3个镇居住半年以上的成年人的3 - 5 ml血样。共11590名乙肝病毒（HBV）表面抗原（HBsAg）、抗HBsAg抗体（Anti - HBs）和抗HBV核心抗原抗体（Anti - HBc）均为阴性的成年人被随机分为四组，分别按照0 - 1 - 6程序接种重组脱氧核糖核酸技术在酿酒酵母中制备的20μg乙肝疫苗（HepB - SC）、中国仓鼠卵巢细胞制备的20μg乙肝疫苗（HepB - CHO）、10μg HepB - SC和重组脱氧核糖核酸技术在多形汉逊酵母中制备的10μg乙肝疫苗（HepB - HP）。对初次乙肝疫苗接种低应答（10 mU/ml≤抗 - HBs＜100 mU/ml）的成年人通过整群随机抽样分为四组，分别用上述四种乙肝疫苗各3剂进行复种。在3剂复种后1个月（T1）和24个月（T24）分别采集血样。采用化学发光微粒子免疫分析（CMIA）法检测抗 - HBs和抗 - HBc。
在8592名接受过乙肝初次接种并采集血样的成年人中，1306名受试者显示低应答。共718名低应答受试者在3剂加强接种后的T1和T24采集了血样。四组比例分别为32.3%（232/718）、25.8%（185/718）、19.3%（139/718）、22.6%（162/718）。抗 - HBs≥100 mIU/ml的平均比例从T1后的77.58%降至T24后的35.63%（χ² = 256.87，P＜0.01）。四组在T24时抗 - HBs≥100 mIU/ml的比例分别为38.8%（90/177）、39.5%（73/185）、25.2%（35/139）和35.8%（58/162）。T24时抗 - HBs＞100 mIU/ml的比例在组间有显著差异（χ² = 8.81，P = 0.032）。平均几何平均浓度（GMC）从T1后的443.53 mIU/ml显著降至T24后的48.98 mIU/ml（F = 439.41，P＜0.01）。四组的GMC分别为60.26（45.71 - 77.62）、1.29（38.90 - 69.18）、35.48（25.70 - 48.98）和46.77（33.88 - 6.07）mIU/ml（F = 1.97，P = 0.117）。与接种20μg HepB - SC相比，抗 - HBs≥100 mIU/ml的比例和GMC分别为0.56（0.35 - 0.91）倍和 - 0.20（ - 0.39 - - 0.02）倍。T24时未发现HBsAg阳性，抗 - HBc阳性率为2.6%（18/692）。
低应答成人接种3剂乙肝疫苗加强免疫2年后保护性抗体消退更快。T24时抗 - HBs抗体水平与加强疫苗类型和年龄有关。20μg HepB - SC似乎优于10μg HepB - SC。
