F Fabrizi1, S V Ganeshan, V Dixit, P Martin. 1. Division of Nephrology and Dialysis, Maggiore Hospital, IRCCS, Milano, Italy. fabrizi@policlinico.mi.it
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. 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.
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.
Authors: Rachel R Bailey; Dianna R Stuckey; Bryan A Norman; Andrew P Duggan; Kristina M Bacon; Diana L Connor; Ingi Lee; Robert R Muder; Bruce Y Lee Journal: Infect Control Hosp Epidemiol Date: 2011-05 Impact factor: 3.254
Authors: Bruce Y Lee; Randy M Stalter; Kristina M Bacon; Julie H Y Tai; Rachel R Bailey; Shanta M Zimmer; Michael M Wagner Journal: Am J Kidney Dis Date: 2011-03-10 Impact factor: 8.860