Published online May 15, 2003. doi: 10.3748/wjg.v9.i5.1132
Revised: April 23, 2002
Accepted: May 10, 2002
Published online: May 15, 2003
AIM: The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group > 40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination.
METHODS: A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg, anti-HBc antibody, HBeAg and anti-HBs antibody) received 20 μg of recombinant HB vaccine intramuscularly at 0, 1, and 6 months. Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days. A booster dose of 20 μg HB vaccine was given after 6 months of the 3rd vaccine dose to the 15 non-responders and anti-HBs titers were measured after 1 month.
RESULTS: Seroprotection (anti-HBs GMT³ 10 IU/L) was achieved in 85.3% (87/102) volunteers. The mean GMT titers of the vaccine responders was 136.1 IU/L. Of the seroprotected individuals, there were 32.4% (33/102) hyporesponders (anti-HBs titers < 10-99 mlU/ml) and 52.9% (54/102) were responders (anti-HBs titers > 100 IU/L). All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose.
CONCLUSION: Recombinant hepatitis B vaccine offers good seroprotection in the age group > 40 years and has a good safety profile. A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers. However, larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.