Intervention Review

Vaccines for preventing hepatitis B in health-care workers

  1. Wendong Chen1,*,
  2. Christian Gluud2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 19 OCT 2005

Assessed as up-to-date: 14 AUG 2005

DOI: 10.1002/14651858.CD000100.pub3


How to Cite

Chen W, Gluud C. Vaccines for preventing hepatitis B in health-care workers. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD000100. DOI: 10.1002/14651858.CD000100.pub3.

Author Information

  1. 1

    Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Departments of Health Policy Management and Evaluation, and Pharmacy, Toronto, Ontario, Canada

  2. 2

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

*Wendong Chen, Departments of Health Policy Management and Evaluation, and Pharmacy, Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Room 679, 6th floor, Leslie L. Dan Pharmacy Building, 144 College Street, Toronto, Ontario, M5S 3M2, Canada. wdchen@uhnres.utoronto.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 OCT 2005

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Hepatitis B virus (HBV) causes acute and chronic liver diseases. Hepatitis B vaccination is recommended for health-care workers.

Objectives

To assess the beneficial and harmful effects of hepatitis B vaccination in health-care workers.

Search methods

We searched the trial registers of The Cochrane Hepato-Biliary Group, The Cochrane Library, MEDLINE, and EMBASE to February 2003.

Selection criteria

Randomised trials comparing any dose, injection route, injection site, or schedule of hepatitis B plasma-derived vaccines (PDV) or recombinant vaccines (RV) versus placebo, no intervention, or another hepatitis B vaccine in health-care workers.

Data collection and analysis

Two reviewers extracted the data independently. The reviewers assessed the methodological quality of the trials regarding generation of the allocation sequence, allocation concealment, double blinding, and follow-up. The results were presented as relative risk (RR) with 95% confidence intervals (CI).

Main results

We identified 21 randomised trials, all with one or more methodological weaknesses. Four trials demonstrated that PDV versus placebo significantly decreased hepatitis B events at maximum follow-up (RR 0.51, 95% CI 0.35 to 0.73). RV did not differ significantly from PDV in eliciting a protective hepatitis B surface antibody (anti-HBs) level in two trials. Both vaccines were well tolerated. Low-dose vaccine (1 or 2 µg) by the intradermal route resulted in significantly more participants without protective anti-HBs level compared with high-dose (10 or 20 µg) by the intramuscular route (RR 1.41, 95% CI 1.13 to 1.76). The intradermal route caused significantly more local adverse events, while the intramuscular route caused significantly more systemic adverse events. The gluteal injection produced significantly more participants without protective anti-HBs level than the deltoid injection. The prevalence of anti-HBs seroconversion by rapid vaccination (0, 1, and 2 months) was significantly lower than that by standard vaccination (0, 1, and 6 months). Booster vaccinations with different RV doses (2.5, 5, 10, 20, or 40 µg) produced similar prevalence of anti-HBs seroconversion in three trials assessing participants who did not respond to previous HBV vaccination.

Authors' conclusions

PDV significantly prevents hepatitis B events. RV seems to be able to elicit similar protective anti-HBs levels. The intramuscular route with 20 µg RV was significantly more effective compared with the intradermal route with 2 µg RV as was the standard schedule compared with a rapid schedule and deltoid intramuscular injection compared with the gluteal intramuscular injection. It is unclear if booster vaccination of non-responders offers higher anti-HBs seroconversion and hepatitis B vaccine prevents the infection of hepatitis B mutants in health-care workers.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Hepatitis B vaccine prevents hepatitis B infection in health-care workers

Plasma-derived vaccine significantly prevents hepatitis B events in health-care workers. Recombinant vaccine does not significantly differ from plasma-derived vaccine in eliciting protective hepatitis B surface antibody levels. Both vaccines are well tolerated. The intramuscular route causes significantly more systemic adverse events, and the intradermal route causes significantly more local adverse events. The deltoid injection seems more effective than the gluteal injection in eliciting antibodies. The standard vaccination schedule (0, 1, and 6 months) elicits a better antibody response than a rapid vaccination schedule (0, 1, and 2 months). It is unknown whether hepatitis B vaccine protects health-care workers from infection of mutated hepatitis B virus.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

B型肝炎疫苗對於健康照護者的保護作用

B型肝炎病毒(HBV)會引起急性和慢性肝臟疾病.健康照護者建議施打B型肝炎疫苗.

目標

評估健康照護者施打B型肝炎疫苗的益處與害處.

搜尋策略

作者搜尋直到2003年2月The Cochrane HepatoBiliary Group的試驗登記資料, The Cochrane Library, MEDLINE, 以及EMBASE等資料庫.

選擇標準

在任何劑量、注射途徑、注射部位或注射時程下,此隨機試驗乃是比較健康照護者接受B型肝炎血漿製劑疫苗(PDV)或合成疫苗(RV),與接受安慰劑、沒有治療、或接受其他B型肝炎疫苗之間的差異。

資料收集與分析

二位作者獨立地選取數據。作者根據分配順序的產生,分配的隱密情形,雙盲和追蹤來評估試驗上方法學的品質。研究的結果以相對危險性(RR)和95%信賴區間(CI)表示。

主要結論

作者選出21個隨機試驗,全部的試驗都有一個或更多方法學上的弱點。4個隨機試驗證明在最大的期間追蹤下,B型肝炎血漿製劑疫苗比安慰劑有顯著地下降B型肝炎的發生(RR 0.51,95% CI 0.35 to 0.73)。有兩個試驗結果顯示合成疫苗並沒有比B型肝炎血漿製劑疫苗更能夠產生保護性的B型肝炎表面抗體(antiHBs)。兩種疫苗都能夠被病患接受。低劑量的疫苗(1或2 μg)經皮內途徑給予與高劑量的(10或20μg) 經肌肉途徑給予相比較,前者參與者B型肝炎表面抗體未達保護程度顯著較多(RR 1.41,95% CI 1.13 to 1.76)。皮內注射途徑引起較多的局部不良反應,而肌肉內途徑引起較多的全身性不良反應。臀部注射與三角肌部位注射比較,B型肝炎表面抗體未達保護程度參與者顯著較多。迅捷接種疫苗療程(0,1,以及2個月)對於B型肝炎表面抗體的血清陽轉率顯著低於標準接種疫苗療程(0,1,以及6個月)的血清陽轉率。3個試驗的結果顯示對先前B型肝炎疫苗無反應的參與者,不同劑量的合成疫苗追加接種(2.5, 5, 10, 20, 或40μg)產生的B型肝炎表面抗體的血清陽轉率相似。

作者結論

B型肝炎血漿製劑疫苗有意義性地預防B型肝炎的發生。合成疫苗似乎也能產生相似的保護性B型肝炎表面抗體數值。肌肉內途徑20μg合成疫苗比2μg皮內注射更有效,而且標準接種疫苗療程比迅速接種疫苗,以及三角肌部位肌肉注射比臀部肌肉注射更有效。是否對於B型肝炎疫苗無反應者追加接種提供更高的B型肝炎表面抗體的血清陽轉率以及B型肝炎疫苗是否對於健康照護者B型肝炎病毒突變株有預防作用是不清楚的。

翻譯人

本摘要由臺中榮民總醫院王建得翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

B型肝炎疫苗可以預防健康照護者B型肝炎病毒感染B型肝炎血漿製劑疫苗顯著地預防B型肝炎感染。合成疫苗與血漿製劑疫苗對於保護性B型肝炎表面抗體數值的產生並無差異。兩種疫苗都能夠被病患接受。皮內注射途徑引起較多的局部不良反應,而肌肉內途徑引起較多的全身性不良反應。三角肌部位肌肉注射比臀部肌肉注射更有效的產生抗體。標準接種疫苗療程(0,1,以及6個月)比迅捷接種疫苗療程(0,1,以及2個月)可以產生更好的B型肝炎表面抗體反應。B型肝炎疫苗是否可以預防健康照護者感染B型肝炎病毒突變株是不清楚的。