【Abstract】 Objective To evaluate the safety and efficacy of the recombinant HBV vaccine made in China in adult hemodialysis patients, and the factors influencing the response to the vaccination. Method We assigned 29 patients (aged 53.1±13.3 years) who had received hemodialysis for more than one month, without previous HBV vaccination, but with negative serum HBV and HCV antibodies and normal liver function, to be vaccinated intradermally with 10μg HBV vaccine 3 times at 0, 1st and 6th months. Anti-HBV antibodies were measured after the last vaccination for 3 months. The medical staffs working in the hemodialysis center with negative serum HBV and HBC antibodies were also vaccinated using the same vaccination schedule as the controls. Result The vaccine was well tolerated. Lower fever (＜38℃) was found in one patient and one control, but without other untoward reactions. All patients completed the 3 vaccinations and serum anti-HBV antibody assays. Positive response to the vaccine was found in 51.7% patients and 70% controls. After 5 years, 11 patients with response to the vaccine were still alive, of whom 9 remained serum positive HBV antibodies, and 2 turned to be negative (one became negative after 2 years, and one after 3 years). Conclusion Lower response to the vaccination exhibited in hemodialysis patients due to their impaired immunological function. In this study, no significant differences in age, sex, primary diseases, body weight, hematocrit, serum calcium and phosphorus, iPTH and dialysis efficacy, but significant differences in serum albumin and pre-albumin (P＜0.05) were found between patients responding to the vaccination and those without response to the vaccination, suggesting that nutrition status of hemodialysis patients may affect the response to the vaccination.