CAJ | 학술논문

目的：观察不同剂量和剂次乙型肝炎疫苗对低／无应答婴儿的再免疫效果及持久性。方法随机选取按0、1、6个月免疫程序接种5μg重组乙型肝炎疫苗（酿酒酵母）后，抗-HBs低／无应答（抗-HBs＜100 mIU／mL），且HB-sAg和HBV DNA均为阴性的7～12月龄婴儿163名为观察对象。随机分为2组，按照0、1、6个月免疫程序，分别用5μg或10μg重组乙型肝炎疫苗进行再免疫，分别于再免疫1剂、3剂后1个月及免疫后4年采集静脉血，用化学发光法检测抗-HBs，比较不同剂量、不同剂次、不同基础免疫状态抗-HBs水平。结果所有研究对象在随访期间均未发生乙肝病毒感染。再免疫1剂和3剂后，两种疫苗均获得较高的免疫应答，10μg汉逊酵母乙肝疫苗组抗-HBs GMC高于5μg酿酒酵母乙肝疫苗组，差异有统计学意义，但4年后差异无统计学意义。对低／无应答婴幼儿再免疫效果分层分析发现，再免疫1剂、3剂和再免疫后4年，低应答组抗-HBs阳性率和GMC均高于无应答组，差异均有统计学意义。结论低／无应答儿童再免疫效果良好，应答水平10μg／剂次组高于5μg／剂次组，但4年后差异无统计学意义。再免疫后的持久性免疫应答效果与初次免疫应答状态有关。
목적：관찰불동제량화제차을형간염역묘대저／무응답영인적재면역효과급지구성。방법수궤선취안0、1、6개월면역정서접충5μg중조을형간염역묘（양주효모）후，항-HBs저／무응답（항-HBs＜100 mIU／mL），차HB-sAg화HBV DNA균위음성적7～12월령영인163명위관찰대상。수궤분위2조，안조0、1、6개월면역정서，분별용5μg혹10μg중조을형간염역묘진행재면역，분별우재면역1제、3제후1개월급면역후4년채집정맥혈，용화학발광법검측항-HBs，비교불동제량、불동제차、불동기출면역상태항-HBs수평。결과소유연구대상재수방기간균미발생을간병독감염。재면역1제화3제후，량충역묘균획득교고적면역응답，10μg한손효모을간역묘조항-HBs GMC고우5μg양주효모을간역묘조，차이유통계학의의，단4년후차이무통계학의의。대저／무응답영유인재면역효과분층분석발현，재면역1제、3제화재면역후4년，저응답조항-HBs양성솔화GMC균고우무응답조，차이균유통계학의의。결론저／무응답인동재면역효과량호，응답수평10μg／제차조고우5μg／제차조，단4년후차이무통계학의의。재면역후적지구성면역응답효과여초차면역응답상태유관。
Objective To observe immunization persistence and effect of booster immunization by hepatitis B vaccine with different dosage and schedule for low/no immune response infants after primary immunization.Methods A total of 163 in-fants were selected ,who were age from 7 to 12 months and had been screened for low/no immune response ( anti-HBs<100 mIU/L) , with both negative for HBsAg and HBV DNA after immunization with 5 μg Saccharomyces cerevisiae vaccine, following up“0,1,6” schedule.The subjects were randomly divided into 2 groups, in accordance with“0,1,6” immuniza-tion schedule with 5μg or 10μg of the vaccine.The blood sample was collected one month after 1,3 doses and 4 years af-ter booster immunization, the detection of anti-HBs was by using chemiluminescence method, and compared the anti-HBs level of different doses, different schedule, different basic immune state.Results During the follow-up period all subjects had no hepatitis B virus infection.The immune responses of 1 dose and 3 doses vaccines were all higher.The anti -HBs GMC of 10μg for the vaccine ( Hansenula yeast) group was higher than that of 5μg for the hepatitis vaccine ( Saccharomy-ces cerevisiae) group, the difference was statistical significance, but 4 years after booster immunization the difference had no statistical significance.The stratified analysis showed that the group for low/no immune response infants with the positive rate of anti-HBs and GMC of low response group were higher than those of no response group, and the difference was statis-tically significant.Conclusion The booster immunization was obtained good results. The immune response after booster immunization of 10 μg dose was better than 5 μg dose, but the difference was not statistically significant 4 years after immuniza-tion.The immune response and persistence after booster immunization were associated with the primary immune response.