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...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 20μg 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 20μg HB vaccine was given after 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) 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 mIU/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.展开更多
目的 评价乙型肝炎(乙肝)疫苗(Hepatitis B vaccine, HepB)和乙肝免疫球蛋白(Hepatitis B immunoglobulin, HBIG)联合免疫阻断乙肝病毒(Hepatitis B virus, HBV)母婴传播的效果和影响因素。方法 在太原市产科医院招募2019-2022年乙肝表...目的 评价乙型肝炎(乙肝)疫苗(Hepatitis B vaccine, HepB)和乙肝免疫球蛋白(Hepatitis B immunoglobulin, HBIG)联合免疫阻断乙肝病毒(Hepatitis B virus, HBV)母婴传播的效果和影响因素。方法 在太原市产科医院招募2019-2022年乙肝表面抗原(Hepatitis B surface antigen, HBsAg)阳性母亲所生新生儿,出生后联合免疫首剂次HepB和HBIG,并完成HepB全程免疫,在新生儿8-24月龄检测血清HBsAg和乙肝表面抗体(Hepatitis B surface antibody, HBsAb),分析HBV母婴传播阻断成功率和影响因素。结果 共纳入HBsAg阳性母亲所生新生儿203名,HBV母婴阻断成功率为98.03%。多因素Logistic回归分析显示乙肝e抗原(Hepatitis B e antigen, HBeAg)同时阳性母亲所生新生儿的母婴传播阻断成功率较低(OR=0.11,95%CI:0.01-0.88)。结论 HepB和HBIG联合免疫对HBsAg阳性母亲所生新生儿的HBV母婴传播阻断总体效果较好,母亲HBeAg同时阳性是影响阻断效果的独立因素。展开更多
文摘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 20μg 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 20μg HB vaccine was given after 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) 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 mIU/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.
文摘目的 评价乙型肝炎(乙肝)疫苗(Hepatitis B vaccine, HepB)和乙肝免疫球蛋白(Hepatitis B immunoglobulin, HBIG)联合免疫阻断乙肝病毒(Hepatitis B virus, HBV)母婴传播的效果和影响因素。方法 在太原市产科医院招募2019-2022年乙肝表面抗原(Hepatitis B surface antigen, HBsAg)阳性母亲所生新生儿,出生后联合免疫首剂次HepB和HBIG,并完成HepB全程免疫,在新生儿8-24月龄检测血清HBsAg和乙肝表面抗体(Hepatitis B surface antibody, HBsAb),分析HBV母婴传播阻断成功率和影响因素。结果 共纳入HBsAg阳性母亲所生新生儿203名,HBV母婴阻断成功率为98.03%。多因素Logistic回归分析显示乙肝e抗原(Hepatitis B e antigen, HBeAg)同时阳性母亲所生新生儿的母婴传播阻断成功率较低(OR=0.11,95%CI:0.01-0.88)。结论 HepB和HBIG联合免疫对HBsAg阳性母亲所生新生儿的HBV母婴传播阻断总体效果较好,母亲HBeAg同时阳性是影响阻断效果的独立因素。