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[重组乙型肝炎疫苗的疗效评估]

[Evaluation of the efficacy of a recombinant hepatitis B vaccine].

作者信息

Polywka S, Gatermann S, von Wulffen H, Laufs R

机构信息

Institut für Medizinische Mikrobiologie und Immunologie der Universität Hamburg.

出版信息

Immun Infekt. 1988 Oct;16(5):175-8.

PMID:3209233
Abstract

A recombinant vaccine against hepatitis B derived from yeast cells (Gen-HB-Vax, Co. MSD/Behring) has been evaluated in 59 healthy young volunteers (37 men, 22 women) with an average age of 24.4 years. The seroconversion rate was 100%, and no major side effects were observed. During a follow-up period of 24 months concentrations of antibodies against HBsAg were shown to decline to one tenth within 16 to 17 months. Triple vaccination led to protective antibody titres for about 27 months on average. Based on these findings we suggest the following recommendations concerning revaccination: an anti-HBs titre of more than 10,000 mIU/ml four weeks after third vaccination should be reassessed 3-5 years later, and titres between 1000 and 10,000 mIU/ml after 2-3 years. A control of the antibody titre should be performed after 1-2 years if the titre is 200-1000 mIU/ml after the third vaccination, and after 6-12 months if it is 100-200 mIU/ml. Antibody titres between 10 and 100 mIU/ml should already be reassessed about 3-6 months later. We recommend an immediate revaccination for persons with anti-HBs titres below 10 mIU/ml. This corresponds to the course of antibody concentrations which could be seen in former studies with the conventional serum-derived vaccine. Maximum anti-HBs titres are slightly below those observed with the serum-derived vaccine.

摘要

一种源自酵母细胞的重组乙肝疫苗(Gen-HB-Vax,默克/贝林公司)在59名健康年轻志愿者(37名男性,22名女性)中进行了评估,他们的平均年龄为24.4岁。血清转化率为100%,未观察到重大副作用。在24个月的随访期内,抗HBsAg抗体浓度在16至17个月内降至十分之一。三次接种平均可产生约27个月的保护性抗体滴度。基于这些发现,我们就再次接种提出以下建议:第三次接种四周后抗HBs滴度超过10,000 mIU/ml的情况应在3至5年后重新评估,2至3年后滴度在1000至10,000 mIU/ml之间的情况也应重新评估。如果第三次接种后滴度为200至1000 mIU/ml,应在1至2年后检查抗体滴度;如果滴度为100至200 mIU/ml,则应在6至12个月后检查。抗HBs滴度在10至100 mIU/ml之间的情况应在约3至6个月后重新评估。我们建议抗HBs滴度低于10 mIU/ml的人立即重新接种。这与以前使用传统血清衍生疫苗的研究中观察到的抗体浓度变化过程一致。最大抗HBs滴度略低于使用血清衍生疫苗时观察到的滴度。

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