Meta-analysis: levamisole improves the immune response to hepatitis B vaccine in dialysis patients

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http://www3.interscience.wiley.com/journal/123587914/abstract?CRETRY=1 & SRETRY=0

Alimentary Pharmacology & Therapeutics

Early View (Articles online in advance of print)

Published Online: 20 Jul 2010

Journal compilation © 2010 Blackwell Publishing Ltd

Meta-analysis: levamisole improves the immune response to hepatitis B vaccine in

dialysis patients

F. Fabrizi*,†, V. Dixit † , P. Messa* & P. †

*Division of Nephrology and Dialysis, Maggiore Hospital, IRCCS Foundation,

Milano, Italy.

† Division of Hepatology, School of Medicine, University of Miami, Miami, FL,

USA.

Correspondence to Dr F. Fabrizi, Division of Nephrology and Dialysis, Maggiore

Hospital, IRCCS Foundation, Pad. Croff, Via Commenda 15, 20122, Milano, Italy.

E-mail: fabrizi@...

Copyright Journal compilation © 2010 Blackwell Publishing Ltd

ABSTRACT

Background Patients undergoing maintenance dialysis often fail to mount

protective antibodies to hepatitis B virus surface antigen (HBsAg) following

vaccination against hepatitis B virus (HBV). Some authors have suggested that

levamisole improves immune response to HBV vaccine in dialysis population.

However, consistent information on this issue does not exist.

Aim To evaluate efficacy and safety of levamisole as adjuvant to hepatitis B

virus (HBV) vaccine in dialysis patients by performing a systematic review of

the literature with a meta-analysis of clinical trials.

Methods We used the random-effects model of DerSimonian and Laird, with

heterogeneity and sensitivity analyses. Only trials comparing the seroresponse

rate in study subjects (levamisole plus HBV vaccine) vs. controls (HBV vaccine

alone) were included. The end point of interest was the rate of patients showing

seroprotective anti-hepatitis B titres at completion of HBV vaccine schedule in

study vs. control groups.

Results We identified four studies involving 328 unique patients on regular

dialysis. Only prospective, randomized clinical trials (RCTs) were included.

Pooling of study results showed a significant increase in response rates among

study (levamisole plus HBV vaccine) vs. control (HBV vaccine alone) patients;

the pooled Odds Ratio was 2.432 (95% Confidence Intervals, 1.34; 4.403), P =

0.002. No study heterogeneity was found. These results did not change in various

subgroups of interest.

Conclusions Our meta-analysis showed that levamisole significantly improves

immune response to hepatitis B vaccine in dialysis population. The limited

number of patients precluded more conclusions.

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Publication data Submitted 5 June 2010 First decision 21 June 2010 Resubmitted

23 June 2010 Accepted 25 June 2010

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1365-2036.2010.04410