Intradermal vs intramuscular vaccine against hepatitis B infection in dialysis patients: a meta-analysis of randomized trials

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http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2010.01354.x/abstract

Intradermal vs intramuscular vaccine against hepatitis B infection in dialysis

patients: a meta-analysis of randomized trials

F. Fabrizi1,2, V. Dixit2, P. Messa1, P. 2

Article first published online: 31 AUG 2010

DOI: 10.1111/j.1365-2893.2010.01354.x

© 2010 Blackwell Publishing Ltd

Issue

Journal of Viral Hepatitis

Volume 18, Issue 10, pages 730–737, October 2011

*Correspondence: Dr Fabrizio Fabrizi, Divisione Nefrologica, Ospedale Maggiore,

Pad. Croff, Via Commenda 15, 20122 Milano, Italy. E-mail:

fabrizi@...

Publication History

Issue published online: 14 SEP 2011

Article first published online: 31 AUG 2010

Received April 2010; accepted for publication May 2010

Summary.  Chronic dialysis patients are at risk of contracting hepatitis B

virus infection and have a diminished immune response to hepatitis B virus

vaccine. Recent reports support intradermal administration of hepatitis B virus

vaccine in patients on regular dialysis but the efficacy and safety of this

approach remain unclear. We conducted a meta-analysis of randomized, controlled

clinical trials to compare seroprotection achieved by intradermal vs

intramuscular hepatitis B vaccine, in patients on maintenance dialysis.

Meta-analysis of data from 718 adults (14 trials) on long-term dialysis

demonstrated that intramuscular hepatitis B vaccination was less likely to

achieve seroprotection than intradermal vaccination, the pooled odds ratio was

0.454 (95% CI, 0.3; 0.67), P = 0.001. The test of study heterogeneity was not

significant. This difference did not persist during follow-up (6–60 months

after completing vaccine schedule), the pooled odds ratio being 0.718 (95% CI,

0.36; 1.47), NS. Some evidence of significant heterogeneity including

publication bias was present but stratified analysis in various subgroups showed

that this issue did not meaningfully change our results. Intradermal hepatitis B

vaccine was safe and well tolerated. We conclude that intradermal hepatitis B

vaccine induces a superior response rate compared to intramuscular route at

completion of vaccine cycle, despite a lower vaccine dose. No significant

advantage was found over longer follow-up. It remains unclear whether the higher

seroprotection rate achieved with intradermal route translates into a lower

frequency of de novo hepatitis B among patients on maintenance dialysis.