Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysisBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.38719.435833.7C (Published 09 February 2006) Cite this as: BMJ 2006;332:328
- Chuanfang Lee, clinical pharmacist1,
- Yan Gong, research assistant ()2,
- Jesper Brok, research assistant2,
- Elizabeth H Boxall, consultant clinical scientist3,
- Christian Gluud, head of department2
- 1 Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Copenhagen University Hospital; Department of Pharmacy Practice, Tri-Service General Hospital, Taipei, Taiwan
- 2 Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, H:S Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark
- 3 Health Protection Agency, Public Health Laboratory, Heart of England NHS Trust, Birmingham
- Correspondence to: Y Gong
- Accepted 14 November 2005
Objective To evaluate the effects of hepatitis B vaccine and immunoglobulin in newborn infants of mothers positive for hepatitis B surface antigen.
Design Systematic review and meta-analysis of randomised clinical trials.
Data sources Electronic databases and hand searches.
Review methods Randomised clinical trials were assessed for methodological quality. Meta-analysis was undertaken on three outcomes: the relative risks of hepatitis B occurrence, antibody levels to hepatitis B surface antigen, and adverse events.
Results 29 randomised clinical trials were identified, five of which were considered high quality. Only three trials reported inclusion of mothers negative for hepatitis B e antigen. Compared with placebo or no intervention, vaccination reduced the occurrence of hepatitis B (relative risk 0.28, 95% confidence interval 0.20 to 0.40; four trials). No significant difference in hepatitis B occurrence was found between recombinant vaccine and plasma derived vaccine (1.00, 0.71 to 1.42; four trials) and between high dose versus low dose vaccine (plasma derived vaccine 0.97, 0.55 to 1.68, three trials; recombinant vaccine 0.78, 0.31 to 1.94, one trial). Compared with placebo or no intervention, hepatitis B immunoglobulin or the combination of plasma derived vaccine and hepatitis B immunoglobulin reduced hepatitis B occurrence (immunoglobulin 0.50, 0.41 to 0.60, one trial; vaccine and immunoglobulin 0.08, 0.03 to 0.17, three trials). Compared with vaccine alone, vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (0.54, 0.41 to 0.73; 10 trials). Hepatitis B vaccine and hepatitis B immunoglobulin seem safe, but few trials reported adverse events.
Conclusion Hepatitis B vaccine, hepatitis B immunoglobulin, and vaccine plus immunoglobulin prevent hepatitis B occurrence in newborn infants of mothers positive for hepatitis B surface antigen.
Contributors CL developed the search strategy, identified trials, extracted data, carried out the statistical analyses, and drafted parts of the review. YG extracted data, carried out the statistical analyses, drafted parts of the review, and revised the review. YG is the guarantor. JB validated the assessment of methodological quality of the included trials, validated data from six randomly selected trials, drafted parts of the review, and revised the review. EHB has research experience in this topic. She provided trials for this review, validated data extraction, and revised the review. CG coordinated the review, functioned as an adjudicator in cases of disagreement, drafted parts of the review, and revised the review.
Funding Tri-Service General Hospital, Taiwan; Copenhagen Trial Unit, Copenhagen University Hospital, Denmark; SC Van Foundation, Denmark; and Public Health Laboratory Service, United Kingdom.
Competing interests None declared.
Ethical approval Not required.