title: Meta-analysis: levamisole improves the immune response to hepatitis B vaccine in dialysis patients.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Maggiore Hospital, IRCCS Foundation, Milano, Italy. fabrizi@policlinico.mi.it
authors.forename: F
authors.initials: F
authors.lastname: Fabrizi
authors.forename: V
authors.initials: V
authors.lastname: Dixit
authors.forename: P
authors.initials: P
authors.lastname: Messa
authors.forename: P
authors.initials: P
authors.lastname: Martin
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003956:Dialysis / Q000379:methods*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000276:immunology* / Q000627:therapeutic use; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000276:immunology*; D007978:Levamisole / Q000276:immunology* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007978:Levamisole