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

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. 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). 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. 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. Our meta-analysis showed improved seroprotection rates with HBV vaccine after GM-CSF administration.