[Comparing the effectiveness of a "short-term double-dose" hepatitis B vaccination schedule with the "standard 3-dose" schedule: a randomized clinical trial]

ABSTRACT

With respect to the importance of hepatitis B vaccination of high-risk groups such as prisoners, this study was performed to assess the comparability of a short-course double-dose vaccination schedule with the standard 3-dose schedule. Within a randomized clinical trial, a short-course vaccination [at months 0 and 1] with 20 microgram [double-dose] doses of the vaccine was compared to the standard method of hepatitis B vaccination [at months 0, 1 and 6, with 10-microgram doses] in 100 prisoners in Zahedan city in Iran in 2009. We made sure the sera from all the individuals were negative for markers of previous hepatitis B infection. Subsequently serum from all the participants was tested for anti-HBs antibody 1, 2 and 7 months after the first dose of vaccination. Seroconversion rates [HBsAb>10 mIU/ml] 1, 2 and 7 months after the first dose of vaccination were similar in the routine [11%, 79% and 94%, respectively] relative to the double-dose group [26%, 95% and 93%, respectively]. The mean values of anti-HBs antibody titers were similar in the 1st and 2nd months for the two groups but it was significantly higher [P=0.002] in the routine dose [514 mIU/ml] versus the double-dose group [130 mIU/mL], in the 7th month. Demonstrating comparable results with the standard 3-dose schedule, it seems that short-term double-dose vaccination for hepatitis B is a safe and acceptable method for use in high-risk groups such as prisoners