Abstract :
Background: HBV vaccination is recommended to prevent superimposed acute or chronic HBV infec-
tion in chronic liver disease patients. The immune response in patients with liver cirrhosis is rather low with the standard dose. We conducted a randomized study comparing a high-dose schedule of hepatitis B vaccine (Engerix B®; 40 mg at 0, 1, 2, and 6 months) and the standard-dose schedule (20 mg at 0, 1, and 6 months) in cirrhotic patients.
Patients and methods: A total of 40 patients were randomized to receive either the standard dose or the high-dose regimen. The anti-HBs titer was measured at the 7th month after administration of the first vaccine dose. Responders were defined as those with an anti-HBs titer ≥ 10 mIU/mL.
Results: 38 subjects completed the study. Sixteen of 18 (88.9%) patients administered with the high-dose regimen seroconverted, compared with 16 of 20 (80%) in the standard-dose group (p=0.663). The mean anti-HBs titer in the high-dose group was significantly greater than of the standard-dose group (754.93 vs. 363.67 mIU/ mL, p=0.01). No other factors including adverse drug reactions showed significant differences between the two study groups (p > 0.05).
Conclusion: There was no significant difference in the response rates between the high-dose and the standard-dose vaccine schedule in cirrhotic patients, although the high-dose regimen was associated with a better response rate.
Key words : High dose, Hepatitis B vaccine, Cirrhosis, Thai |