title: Meta-analysis: the adjuvant role of granulocyte macrophage-colony stimulating factor on immunological response to hepatitis B virus vaccine in end-stage renal disease.
abstract: BACKGROUND
  Chronic dialysis patients often fail to produce protective antibodies to hepatitis B virus surface antigen after vaccination towards hepatitis B virus (HBV). Several authors suggested a benefit for granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant to HBV vaccination in patients with end-stage renal disease (ESRD). However, consistent information is still lacking.
  
  
  OBJECTIVE
  To evaluate efficacy and safety of GM-CSF as adjuvant to hepatitis B vaccine in patients with ESRD by performing a systematic review with a meta-analysis of prospective controlled clinical trials (CCTs).
  
  
  METHODS
  Only trials comparing the seroresponse rate in study (GM-CSF plus HBV vaccine) versus control (HBV vaccine alone) patients were included. We used the random effects model of DerSimonian and Laird, with heterogeneity and sensitivity analyses. The end-point of interest was the rate of patients showing seroprotective anti-hepatitis B titers at completion of HBV vaccine schedule in study versus control groups.
  
  
  RESULTS
  We identified seven studies involving 187 unique patients with ESRD. Only prospective CCTs were included. Pooling of study results showed a significant increase in response rates among study (GM-CSF plus HBV vaccine) versus control (HBV vaccine alone) patients (pooled Odds Ratio, 4.63 [95% Confidence Intervals, 1.42; 15.14]). The P-value was 0.02 for our test of study heterogeneity.
  
  
  CONCLUSIONS
  Our meta-analysis showed improved seroprotection rates with HBV vaccine after GM-CSF administration.
authors.affiliation: Division of Nephrology and Dialysis, Maggiore Hospital, IRCCS, Milano, Italy. fabrizi@policlinico.mi.it
authors.forename: F
authors.initials: F
authors.lastname: Fabrizi
authors.forename: S V
authors.initials: SV
authors.lastname: Ganeshan
authors.forename: V
authors.initials: V
authors.lastname: Dixit
authors.forename: P
authors.initials: P
authors.lastname: Martin
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000276:immunology* / Q000627:therapeutic use; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000276:immunology*; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D016178:Granulocyte-Macrophage Colony-Stimulating Factor