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AIM:The study was initiated to evaluate the reactogenicityand immunogenicity of a recombinant hepatitis B vaccine inage group >40 years and to study the response of a singlebooster dose in primary non-responders to the hepatitis Bvaccination.METHODS:A total of 102 volunteers without markers ofhepatitis B infection (negative for HBsAg,anti-HBc antibody,HBeAg and anti-HBs antibody) received 20μg of recombinantHB vaccine intramuscularly at 0,1,and 6 months.Anti HBstiters were evaluated by a quantitative Elisa kit at 90 and210 days.A booster dose of 20μg HB vaccine was givenafter 6 months of the 3~(rd) vaccine dose to the 15 non-responders and anti-HBs titers were measured after i month.RESULTS:Seroprotection (anti-HBs GMT~3 10 IU/L) wasachieved in 85.3 % (87/102) volunteers.The mean GMT titersof the vaccine responders was 136.1 IU/L.Of the seroprotectedindividuals,there were 32.4% (33/102) hyporesponders (anti-HBs titers <10-99 mIU/ml) and 52.9% (54/102) wereresponders (anti-HBs titers >100 IU/L).All the non-responders(15/15) responded to a single dose of the booster dose ofrecombinant HB vaccine and their mean anti-HBs antibodytiters were more than 100.5 mIU/ml after the booster dose.CONCLUSION:Recombinant hepatitis B vaccine offers goodseroprotection in the age group >40 years and has a goodsafety profile.A single booster dose after 6 months in primarynon-responders leads to good seroprotective anti-HBsantibody titers.However,larger population based studiesare needed to evaluate the role of a booster dose in selectedgroup of non-responders and whether such an approachwill be cost effective.
AIM: The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine inage group> 40 years and to study the response of a singlebooster dose in primary non-responders to the hepatitis B virus. METHODS: A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg, anti-HBc antibody, HBeAg and anti-HBs antibody) was 20 μg of recombinant HB vaccine intramuscularly at 0, 1 and 6 months. Anti HBstiters were evaluated by a quantitative Elisa kit at 90 and 210 days. A booster dose of 20 μg HB vaccine was give after about 6 months of the 3 ~ (rd) vaccine dose to the 15 non-responders and anti-HBs titers were measured after 1 month .RESULTS: Seroprotection (anti-HBs GMT ~ 3 10 IU / L ) wereachieved in 85.3% (87/102) volunteers. The mean GMT titers of the vaccine responders were 136.1 IU / L.Of the seroprotected individuals, there were 32.4% (33/102) hyporesponders (anti-HBs titers <10-99 mIU / ml) and 52.9% (54/102) wereresponders (anti-HBs titers > 100 IU / L) .All the non-responders (15/15) responded to a single dose of the booster dose ofrecombinant HB vaccine and their mean anti-HBs antibodytiters were more than 100.5 mIU / ml after the booster dose. CONCLUSION: Recombinant hepatitis B vaccine offers good protection in the age group> 40 years and has a goods safety profile. A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody body. Host, Large population based studiesare needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach beill be cost effective.