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成人接种甲乙肝联合疫苗(安在时)后的十年抗体持久性。

Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults.

作者信息

Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B

机构信息

Centre for the Evaluation of Vaccination, WHO Collaborating Centre for Prevention and Control of Viral Hepatitis, Unit of Epidemiology and Social Medicine, University of Antwerp - Campus Drie Eiken, Wilrijk, Belgium.

出版信息

Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20.

Abstract

BACKGROUND

Hepatitis A and B infections are prevalent worldwide and cause significant morbidity and mortality. A combined vaccine providing dual protection against hepatitis A and B is available (Twinrix, GlaxoSmithKline Biologicals).

METHOD

Two cohorts of adults aged 17-43 years were vaccinated with Twinrix according to a 0, 1, 6 months schedule and followed up for 10 years.

RESULTS

One month after the primary vaccination course (Month 7), all subjects were seropositive for anti-HAV and all had anti-HBs> or = 10 mIU/ml. At month 120, 100% of subjects (N=34; N=29) in both cohorts were seropositive for anti-HAV; 94.1% and 86.2% of subjects had anti-HBs > or = 10 mIU/ml. The geometric mean concentrations (GMC; mIU/ml) were 373.9 and 674.6 in the two cohorts for anti-HAV, and 103.8 and 320.0, respectively, for anti-HBs. None of the serious adverse events reported throughout the follow-up period were considered by the investigator to be causally related to vaccination.

CONCLUSIONS

Combined hepatitis A and B vaccine, Twinrix, is safe, well-tolerated and has demonstrated a highly immunogenic profile. Persistence of anti-HAV and anti-HBs antibodies in adults remains high for at least 10 years after primary vaccination.

摘要

背景

甲型和乙型肝炎感染在全球范围内普遍存在,会导致严重的发病和死亡。有一种联合疫苗(安在时,葛兰素史克生物制品公司)可提供针对甲型和乙型肝炎的双重保护。

方法

两组年龄在17 - 43岁的成年人按照0、1、6个月的接种程序接种安在时,并进行了10年的随访。

结果

在初次接种疫苗疗程后1个月(第7个月),所有受试者抗甲型肝炎病毒(anti - HAV)血清学呈阳性,且所有受试者抗乙型肝炎表面抗体(anti - HBs)≥10 mIU/ml。在第120个月时,两个队列中的所有受试者(N = 34;N = 29)抗甲型肝炎病毒均呈血清学阳性;94.1%和86.2%的受试者抗乙型肝炎表面抗体≥10 mIU/ml。两个队列中抗甲型肝炎病毒的几何平均浓度(GMC;mIU/ml)分别为373.9和674.6,抗乙型肝炎表面抗体的几何平均浓度分别为103.8和320.0。在整个随访期间报告的严重不良事件,研究者均认为与接种疫苗无因果关系。

结论

甲型和乙型肝炎联合疫苗安在时安全、耐受性良好,并已显示出高度的免疫原性。初次接种疫苗后,成年人中抗甲型肝炎病毒和抗乙型肝炎表面抗体至少10年内持续保持高滴度。

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