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10微克和20微克乙肝疫苗的免疫原性、疗效及安全性比较:一项前瞻性随机试验

Comparison of the immunogenicity, efficacy and safety of 10 micrograms and 20 micrograms of a hepatitis B vaccine: a prospective randomized trial.

作者信息

Yeoh E K, Lai C L, Chang W K, Lo H Y

出版信息

J Hyg (Lond). 1986 Jun;96(3):491-9. doi: 10.1017/s0022172400066298.

DOI:10.1017/s0022172400066298
PMID:2942599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2129698/
Abstract

Four thousand and one hospital staff were screened for hepatitis B virus (HBV) markers in a vaccination programme in Hong Kong. The seropositivity rate for HBsAg, anti-HBs and anti-HBc were significantly higher in the 3160 existing hospital staff than in 841 new recruits. Of the subjects negative for HBV markers, 605 were randomized to receive three doses of either 10 or 20 micrograms of the Merck Institute vaccine (HB-VAX). Compared with the 20 micrograms dose, vaccination with the 10 micrograms dose results in equal immunogenicity and efficacy at the completion of the three injections but induced a slower response rate and lower anti-HBs titres with the first two doses. The commonest side-effect of local soreness was less with the 10 micrograms dose. We conclude that (1) hospital staff working in high endemic areas should be vaccinated on recruitment and (2) the 10 micrograms dose of HB-VAX can replace the recommended 20 micrograms dose for adults, being cheaper and as efficacious.

摘要

在香港的一项疫苗接种计划中,对4001名医院工作人员进行了乙肝病毒(HBV)标志物筛查。3160名在职医院工作人员的HBsAg、抗-HBs和抗-HBc血清阳性率显著高于841名新入职人员。在HBV标志物呈阴性的受试者中,605人被随机分为两组,分别接种3剂10微克或20微克的默克研究所疫苗(HB-VAX)。与20微克剂量相比,10微克剂量的疫苗在完成3次注射后具有相同的免疫原性和效力,但在前两剂注射时诱导的反应率较慢,抗-HBs滴度较低。10微克剂量的疫苗最常见的局部疼痛副作用较少。我们得出结论:(1)在高流行地区工作的医院工作人员应在入职时接种疫苗;(2)10微克剂量的HB-VAX可以替代推荐的20微克成人剂量,价格更便宜且效果相同。

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Comparison of the immunogenicity, efficacy and safety of 10 micrograms and 20 micrograms of a hepatitis B vaccine: a prospective randomized trial.10微克和20微克乙肝疫苗的免疫原性、疗效及安全性比较:一项前瞻性随机试验
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引用本文的文献

1
Adverse events after hepatitis B vaccination.乙肝疫苗接种后的不良事件。
CMAJ. 1992 Oct 1;147(7):1023-6.

本文引用的文献

1
Immunogenic effect of inactivated hepatitis B vaccine: comparison of 20 microgram and 40 microgram doses.灭活乙型肝炎疫苗的免疫原性效应:20微克和40微克剂量的比较
J Med Virol. 1981;8(2):119-21. doi: 10.1002/jmv.1890080205.
2
Comparison of safety and immunogenicity of ADW and AYW hepatitis B vaccines.ADW型和AYW型乙型肝炎疫苗的安全性和免疫原性比较。
J Med Virol. 1982;9(3):231-6. doi: 10.1002/jmv.1890090310.
3
A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report.乙肝疫苗(Heptavax B)疗效的对照临床试验:最终报告
Hepatology. 1981 Sep-Oct;1(5):377-85. doi: 10.1002/hep.1840010502.
4
Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States.乙肝疫苗:在美国高危人群的对照临床试验中疗效的证明
N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.
5
The immune response of healthy Nigerian adults to small doses of hepatitis B vaccine: comparison of 10- and 20-micrograms doses.
J Med Virol. 1984;13(3):223-5. doi: 10.1002/jmv.1890130304.
6
Reduction of the dose of hepatitis B vaccine.降低乙肝疫苗剂量。
J Infect. 1983 Jul;7 Suppl 1:69-70. doi: 10.1016/s0163-4453(83)96718-x.
7
Immune responses to active and passive-active vaccination against hepatitis B.针对乙肝主动及被动-主动疫苗接种的免疫反应。
J Infect. 1983 Jul;7 Suppl 1:21-5. doi: 10.1016/s0163-4453(83)96534-9.
8
Human hepatitis B vaccine from recombinant yeast.重组酵母乙型肝炎疫苗
Nature. 1984;307(5947):178-80. doi: 10.1038/307178a0.
9
Clinical evaluation in healthy adults of a hepatitis B vaccine made by recombinant DNA.重组DNA乙肝疫苗在健康成年人中的临床评估。
JAMA. 1984 Jun 1;251(21):2812-5.
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Hepatitis B virus infection in dentists.牙医中的乙型肝炎病毒感染
N Engl J Med. 1975 Oct 9;293(15):729-34. doi: 10.1056/NEJM197510092931501.