Meta-analysis: The adjuvant role of granulocyte macrophage-colony stimulating factor on immunological response to hepatitis B virus vaccine in end-stage renal disease

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. Aims: 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.