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对一种国产重组乙型肝炎疫苗无反应的发生率:在一家三级医院对南印度医护人员开展的一项研究。

Prevalence of non-responsiveness to an indigenous recombinant hepatitis B vaccine: a study among South Indian health care workers in a tertiary hospital.

作者信息

Thomas R J, Fletcher G J, Kirupakaran H, Chacko M P, Thenmozhi S, Eapen C E, Chandy G, Abraham P

机构信息

Department of Clinical Virology, Christian Medical College Hospital, Vellore, Tamil Nadu, India.

出版信息

Indian J Med Microbiol. 2015 Feb;33 Suppl:32-6. doi: 10.4103/0255-0857.150877.

DOI:10.4103/0255-0857.150877
PMID:25657153
Abstract

BACKGROUND AND AIM

Health care workers (HCW) are at higher risk of contracting HBV infection. Non-response to HBV vaccine is one of the major impediments to prevent healthcare associated HBV infection (HAHI). We estimated the prevalence of non-responsiveness to initial 3-dose regimen of an indigenous recombinant HBV vaccine (GeneVac-B) among South Indian HCWs and typed the HLA in non-responders.

STUDY DESIGN AND METHOD

Of the 778 subjects screened over 1 year, 454 completed all three doses of the hepatitis B vaccination. Anti-HBs titers were estimated by microparticle enzyme immunoassay AxSYM AUSAB, (Abbott, Germany). HLA typing was done using SSP-PCR assay AllSet+™ Gold SSP (Invitrogen, USA).

RESULTS

The overall seroconversion rate (anti-HBs>10 mIU/mL) was 98.89% wherein 90.8% had titers>1000mIU/mL, 7.6% had titers 100-1000mIU/mL, 0.43% had titers<100 mIU/mL and 1.1% were non-responsive (<10 mIU/mL) to the initial 3-dose regimen. Antibody titers<1000 mIU/mL were significantly associated with the highest quartile of body mass index (BMI) (P<0.001). We found no significant difference in seroprotection rate between gender (P=0.088). There was no difference in seroprotection rates among various ethnic groups (P=0.62). Subjects who were non-responsive in our study had at least one HLA allele earlier known to be associated with non-responsiveness to the vaccine.

CONCLUSION

Our findings suggest that non-response to HBV vaccine is not a major impediment to prevent HAHI. Robust seroprotection rates can be achieved using this indigenous HBV vaccine. However, gender and BMI might influence the level of anti-HBs titers. We recommend the use of this cost effective HBV vaccine as well as postvaccination anti-HBs testing to prevent HAHI among HCWs.

摘要

背景与目的

医护人员感染乙肝病毒(HBV)的风险更高。对乙肝疫苗无应答是预防医疗相关HBV感染(HAHI)的主要障碍之一。我们估算了印度南部医护人员对国产重组乙肝疫苗(GeneVac - B)初始3剂接种方案无应答的流行率,并对无应答者进行了HLA分型。

研究设计与方法

在1年多的时间里筛选了778名受试者,其中454人完成了全部3剂乙肝疫苗接种。采用微粒酶免疫分析法AxSYM AUSAB(德国雅培公司)检测抗 - HBs滴度。使用SSP - PCR分析法AllSet +™ Gold SSP(美国英杰公司)进行HLA分型。

结果

总体血清转化率(抗 - HBs>10 mIU/mL)为98.89%,其中90.8%的滴度>1000 mIU/mL,7.6%的滴度为100 - 1000 mIU/mL,0.43%的滴度<100 mIU/mL,1.1%对初始3剂接种方案无应答(<10 mIU/mL)。抗体滴度<1000 mIU/mL与体重指数(BMI)最高四分位数显著相关(P<0.001)。我们发现性别之间的血清保护率无显著差异(P = 0.088)。不同种族之间的血清保护率也无差异(P = 0.62)。在我们的研究中无应答的受试者至少有一个先前已知与疫苗无应答相关的HLA等位基因。

结论

我们的研究结果表明,对乙肝疫苗无应答并非预防HAHI的主要障碍。使用这种国产乙肝疫苗可实现较高的血清保护率。然而,性别和BMI可能会影响抗 - HBs滴度水平。我们建议使用这种经济有效的乙肝疫苗以及接种后进行抗 - HBs检测,以预防医护人员中的HAHI。

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