不同剂量国产重组酵母乙型肝炎疫苗成年人免疫效果及影响因素研究
불동제량국산중조효모을형간염역묘성년인면역효과급영향인소연구
Study on the immuno-effects and influencing factors of Chinese Hamster Ovary (CHO) cell hepatitis B vaccine among adults, under different dosages
  • 万方数据
    中华流行病学杂志 중화류행병학잡지
    CHINESE JOURNAL OF EPIDEMIOLOGY
    2010年 7期 767-770 ,共4页

    张卫%林长缨%韩莉莉%李立秋%高培%林晖%龚晓红%黄芳%唐雅清%马建新%张海燕%王晨%杨鹏%李辉%孙美平%贺雄%庞星火

    장위%림장영%한리리%리립추%고배%림휘%공효홍%황방%당아청%마건신%장해연%왕신%양붕%리휘%손미평%하웅%방성화

    乙型肝炎疫苗,国产重组酵母%乙型肝炎表面抗体%随机双盲对照试验%多因素分析 乙型肝炎疫苗,國產重組酵母%乙型肝炎錶麵抗體%隨機雙盲對照試驗%多因素分析
    을형간염역묘,국산중조효모%을형간염표면항체%수궤쌍맹대조시험%다인소분석
    Recombinant CHO hepatitis B vaccine%Anti-HBs%Randomized double-blind controlled trials%Multivariate analysis
    目的 通过随机双盲对照试验,评价10μg和20μg国产重组酵母(CHO)乙型肝炎(乙肝)疫苗应用于成年人的免疫效果,以及影响免疫效果的个体因素.方法 在北京市4个区县范围内选择18～45岁未接种乙肝疫苗、乙肝五项指标均为阴性的642名成年人作为研究对象,随机分为两组,按照"0-1-6"程序分别接种10μg和20μg CHO乙肝疫苗,通过问卷方法调查每个对象可能影响乙肝疫苗免疫效果的个体因素.于接种第三针1个月后采血,以雅培化学发光的方法检测抗-HBs滴度值,抗-HBs阴性者采用荧光定量PCR方法进一步检测HBV DNA,利用logistic回归分析方法分析影响抗-HBs阳转的个体因素.结果 10μg和20μg两个剂量组抗-HBs阳转率分别为88.8%(95%CI:85.4%～92.2%)和95.3%(95%CI:93.0%～97.6%).按照抗-HBs＜100 mIU/ml为低无应答标准,低无应答率分别为34.3%和17.4%;抗体几何平均滴度(GMT)分别为173.42 mIU/ml和588.51 mIU/ml.多因素分析表明:患糖尿病、配偶为乙肝病毒感染者以及大年龄组人群是抗体阳转不利因素,而20μg疫苗剂量有利于抗体阳转.结论 CHO乙肝疫苗20μg免疫效果优于10μg,乙肝疫苗免疫效果评价应考虑多因素的影响.
    목적 통과수궤쌍맹대조시험,평개10μg화20μg국산중조효모(CHO)을형간염(을간)역묘응용우성년인적면역효과,이급영향면역효과적개체인소.방법 재북경시4개구현범위내선택18～45세미접충을간역묘、을간오항지표균위음성적642명성년인작위연구대상,수궤분위량조,안조"0-1-6"정서분별접충10μg화20μg CHO을간역묘,통과문권방법조사매개대상가능영향을간역묘면역효과적개체인소.우접충제삼침1개월후채혈,이아배화학발광적방법검측항-HBs적도치,항-HBs음성자채용형광정량PCR방법진일보검측HBV DNA,이용logistic회귀분석방법분석영향항-HBs양전적개체인소.결과 10μg화20μg량개제량조항-HBs양전솔분별위88.8%(95%CI:85.4%～92.2%)화95.3%(95%CI:93.0%～97.6%).안조항-HBs＜100 mIU/ml위저무응답표준,저무응답솔분별위34.3%화17.4%;항체궤하평균적도(GMT)분별위173.42 mIU/ml화588.51 mIU/ml.다인소분석표명:환당뇨병、배우위을간병독감염자이급대년령조인군시항체양전불리인소,이20μg역묘제량유리우항체양전.결론 CHO을간역묘20μg면역효과우우10μg,을간역묘면역효과평개응고필다인소적영향.
    Objective To evaluate the immuno-effect and related influencing factors on 10 μg and 20 μg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population. Methods A total of 642 adults aged 18-45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 tg and 20 μg recombinant CHO hepatitis B vaccination by 0-1-6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject. Results The anti-HBs seroconversion rates on 10 μg and 20 μg dose groups were 88.8%(95%CI: 85.4%-92.2%) and 95.3%(95%CI: 93.0%-97.6%)respectively. Taking the anti-HBs level＜100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers(GMT)of anti-HBs were 173.42 mIU/ml for the 10 μg dose group and 588.51 mIU/ml for the 20 μg dose group. Data from the Multivariate analysis showed that: diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 μg dose of the vaccine was conducive to seroconversion.Conclusion 20 μg CHO hepatitis B vaccine seemed better than 10 μg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines.
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