中华预防医学杂志
中華預防醫學雜誌
중화예방의학잡지
CHINESE JOURNAL OF
2014年
12期
1043-1047
,共5页
颜丙玉%吕静静%刘甲野%冯艺%徐爱强%陈士玉%周立波%梁晓峰%崔富强%王富珍%张丽
顏丙玉%呂靜靜%劉甲野%馮藝%徐愛彊%陳士玉%週立波%樑曉峰%崔富彊%王富珍%張麗
안병옥%려정정%류갑야%풍예%서애강%진사옥%주립파%량효봉%최부강%왕부진%장려
成年人%肝炎疫苗,乙型%免疫接种,加强%低应答者%免疫持久性
成年人%肝炎疫苗,乙型%免疫接種,加彊%低應答者%免疫持久性
성년인%간염역묘,을형%면역접충,가강%저응답자%면역지구성
Adult%Hepatitis B vaccine%Immunization,secondary%Low-respond%Immune persistence
目的:评价成年人乙型肝炎疫苗( HepB)初次免疫低应答者加强免疫后24个月的免疫持久性效果。方法于2009年9月,以山东省济南章丘市3个乡镇共79个村为研究场所,按照整群随机抽样原则,选取既往无乙型肝炎病毒( HBV)感染史和HepB免疫史、居住6个月以上、健康状况良好的18~49岁居民,共24237名,采集静脉血3~5 ml,采用酶联免疫吸附试验法检测乙型肝炎表面抗原( HBsAg)、乙型肝炎表面抗体(抗-HBs)和乙型肝炎核心抗体(抗-HBc)。经检测以上3项指标均为阴性者11590名,采用整群随机抽样方法,将其分为4组,再按照0-1-6免疫程序,分别采用20μg重组酵母 HepB(HepB-SC)、20μg 重组中国仓鼠卵巢细胞(HepB-CHO)、10μg HepB-SC 和10μg重组汉逊酵母HepB(HepB-HP)进行初次免疫。初次免疫后,按照0-1-6程序,采用以上4种HepB,对初次免疫低应答者进行加强免疫,其所属组别不变。于加强免疫后1个月( T1)、24个月( T24)分别采集静脉血5 ml,采用化学发光微粒子免疫分析法检测抗-HBs和抗-HBc。结果8592名调查对象完成3剂次HepB初次免疫并采集静脉血,其初次免疫低应答率为15.20%(1306/8592),完成加强免疫并于T1、T24时采集静脉血的调查对象占54.98%(718/1306),其中,20μg HepB-SC组、20μgHepB-CHO组、10μg HepB-SC组和10μg HepB-HP组分别占32.3%(232/718)、25.8%(185/718)、19.3%(139/718)、22.6%(162/718)。 T1时,低应答者的抗体阳性率为77.6%(557/718),高于T24时[35.6%(256/718);χ2=256.87,P<0.01]。 T24时,20μg HepB-SC 组、20μg HepB-CHO 组、10μg HepB-SC组和10μg HepB-HP组的抗-HBs阳性率分别为38.8%(90/177)、39.5%(73/185)、25.2%(35/139)和35.8%(58/162)(χ2=8.81,P=0.032)。 T1时,总抗体几何平均浓度(GMC)(95%CI)为443.53(385.11~510.82) mIU/ml,高于 T24时[48.98(42.66~57.54) mIU/ml](F =439.41,P <0.01)。 T24时,4组的抗体 GMC(95%CI)水平分别为60.26(45.71~77.62)、51.29(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)。 T24时,接种10μg HepB-SC疫苗者的抗-HBs阳性率和抗体GMC水平分别是接种20μg HepB-SC者0.56(0.35~0.91)与-0.20(-0.39~-0.02)倍。 T24时,无HBsAg阳性者,抗-HBc阳性率为2.6%(18/692)。结论成年人HepB初次免疫低应答者3剂次加强免疫后24个月时抗-HBs水平降低,其长期抗体水平主要与加强免疫所用疫苗种类有关,采用20μg HepB-SC进行加强免疫者的免疫持久性优于采用10μg HepB-SC者。
目的:評價成年人乙型肝炎疫苗( HepB)初次免疫低應答者加彊免疫後24箇月的免疫持久性效果。方法于2009年9月,以山東省濟南章丘市3箇鄉鎮共79箇村為研究場所,按照整群隨機抽樣原則,選取既往無乙型肝炎病毒( HBV)感染史和HepB免疫史、居住6箇月以上、健康狀況良好的18~49歲居民,共24237名,採集靜脈血3~5 ml,採用酶聯免疫吸附試驗法檢測乙型肝炎錶麵抗原( HBsAg)、乙型肝炎錶麵抗體(抗-HBs)和乙型肝炎覈心抗體(抗-HBc)。經檢測以上3項指標均為陰性者11590名,採用整群隨機抽樣方法,將其分為4組,再按照0-1-6免疫程序,分彆採用20μg重組酵母 HepB(HepB-SC)、20μg 重組中國倉鼠卵巢細胞(HepB-CHO)、10μg HepB-SC 和10μg重組漢遜酵母HepB(HepB-HP)進行初次免疫。初次免疫後,按照0-1-6程序,採用以上4種HepB,對初次免疫低應答者進行加彊免疫,其所屬組彆不變。于加彊免疫後1箇月( T1)、24箇月( T24)分彆採集靜脈血5 ml,採用化學髮光微粒子免疫分析法檢測抗-HBs和抗-HBc。結果8592名調查對象完成3劑次HepB初次免疫併採集靜脈血,其初次免疫低應答率為15.20%(1306/8592),完成加彊免疫併于T1、T24時採集靜脈血的調查對象佔54.98%(718/1306),其中,20μg HepB-SC組、20μgHepB-CHO組、10μg HepB-SC組和10μg HepB-HP組分彆佔32.3%(232/718)、25.8%(185/718)、19.3%(139/718)、22.6%(162/718)。 T1時,低應答者的抗體暘性率為77.6%(557/718),高于T24時[35.6%(256/718);χ2=256.87,P<0.01]。 T24時,20μg HepB-SC 組、20μg HepB-CHO 組、10μg HepB-SC組和10μg HepB-HP組的抗-HBs暘性率分彆為38.8%(90/177)、39.5%(73/185)、25.2%(35/139)和35.8%(58/162)(χ2=8.81,P=0.032)。 T1時,總抗體幾何平均濃度(GMC)(95%CI)為443.53(385.11~510.82) mIU/ml,高于 T24時[48.98(42.66~57.54) mIU/ml](F =439.41,P <0.01)。 T24時,4組的抗體 GMC(95%CI)水平分彆為60.26(45.71~77.62)、51.29(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)。 T24時,接種10μg HepB-SC疫苗者的抗-HBs暘性率和抗體GMC水平分彆是接種20μg HepB-SC者0.56(0.35~0.91)與-0.20(-0.39~-0.02)倍。 T24時,無HBsAg暘性者,抗-HBc暘性率為2.6%(18/692)。結論成年人HepB初次免疫低應答者3劑次加彊免疫後24箇月時抗-HBs水平降低,其長期抗體水平主要與加彊免疫所用疫苗種類有關,採用20μg HepB-SC進行加彊免疫者的免疫持久性優于採用10μg HepB-SC者。
목적:평개성년인을형간염역묘( HepB)초차면역저응답자가강면역후24개월적면역지구성효과。방법우2009년9월,이산동성제남장구시3개향진공79개촌위연구장소,안조정군수궤추양원칙,선취기왕무을형간염병독( HBV)감염사화HepB면역사、거주6개월이상、건강상황량호적18~49세거민,공24237명,채집정맥혈3~5 ml,채용매련면역흡부시험법검측을형간염표면항원( HBsAg)、을형간염표면항체(항-HBs)화을형간염핵심항체(항-HBc)。경검측이상3항지표균위음성자11590명,채용정군수궤추양방법,장기분위4조,재안조0-1-6면역정서,분별채용20μg중조효모 HepB(HepB-SC)、20μg 중조중국창서란소세포(HepB-CHO)、10μg HepB-SC 화10μg중조한손효모HepB(HepB-HP)진행초차면역。초차면역후,안조0-1-6정서,채용이상4충HepB,대초차면역저응답자진행가강면역,기소속조별불변。우가강면역후1개월( T1)、24개월( T24)분별채집정맥혈5 ml,채용화학발광미입자면역분석법검측항-HBs화항-HBc。결과8592명조사대상완성3제차HepB초차면역병채집정맥혈,기초차면역저응답솔위15.20%(1306/8592),완성가강면역병우T1、T24시채집정맥혈적조사대상점54.98%(718/1306),기중,20μg HepB-SC조、20μgHepB-CHO조、10μg HepB-SC조화10μg HepB-HP조분별점32.3%(232/718)、25.8%(185/718)、19.3%(139/718)、22.6%(162/718)。 T1시,저응답자적항체양성솔위77.6%(557/718),고우T24시[35.6%(256/718);χ2=256.87,P<0.01]。 T24시,20μg HepB-SC 조、20μg HepB-CHO 조、10μg HepB-SC조화10μg HepB-HP조적항-HBs양성솔분별위38.8%(90/177)、39.5%(73/185)、25.2%(35/139)화35.8%(58/162)(χ2=8.81,P=0.032)。 T1시,총항체궤하평균농도(GMC)(95%CI)위443.53(385.11~510.82) mIU/ml,고우 T24시[48.98(42.66~57.54) mIU/ml](F =439.41,P <0.01)。 T24시,4조적항체 GMC(95%CI)수평분별위60.26(45.71~77.62)、51.29(38.90~69.18)、35.48(25.70~48.98)화46.77(33.88~6.07) mIU/ml(F=1.97,P=0.117)。 T24시,접충10μg HepB-SC역묘자적항-HBs양성솔화항체GMC수평분별시접충20μg HepB-SC자0.56(0.35~0.91)여-0.20(-0.39~-0.02)배。 T24시,무HBsAg양성자,항-HBc양성솔위2.6%(18/692)。결론성년인HepB초차면역저응답자3제차가강면역후24개월시항-HBs수평강저,기장기항체수평주요여가강면역소용역묘충류유관,채용20μg HepB-SC진행가강면역자적면역지구성우우채용10μg HepB-SC자。
Objective 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.Methods 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) , 20μg hepatitis B vaccine made by Chinese hamster ovary cell ( HepB-CHO) , 10μg 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 1month( T1 ) and 24 month( T24 ) after the 3 dose revaccination, respectively.Anti-HBs and anti-HBc was detected by Chemiluminescence Microparticle Imunoassay( CMIA) . Results 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 .Conclusion 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.20μgHepB-SC seemed better than 10 μg HepB-SC.