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
目的评价甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine，Inactivated；HepA—I）和甲乙型肝炎联合灭活疫苗（Hepatitis A and B Combined Vaccine，Inactivated；HepAB—I）一剂再免疫的血清学效果和安全性。方法采用开放式临床研究...目的评价甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine，Inactivated；HepA—I）和甲乙型肝炎联合灭活疫苗（Hepatitis A and B Combined Vaccine，Inactivated；HepAB—I）一剂再免疫的血清学效果和安全性。方法采用开放式临床研究设计，选择210名已经完成乙型肝炎（乙肝）疫苗（Hepatitis B Vaccine，HepB）全程免疫、且接种甲肝减毒活疫苗（Hepatitis A Attenuated Live Vaccine，HepA-L）≥6个月的24-38月龄儿童，分为2个试验组，分别接种1剂HepA—J和HepAB—I，并在免疫前和免疫后1个月，对受试者采血检测抗甲肝病毒抗体（Antibodyto Hepatitis A Virus，Anti—HAV）与抗乙肝病毒表面抗原抗体（Antibodvto Hepatitis B Virtus Surface Antigen，Anti-HBs），并对受试者连续3d测体温，并观察可能发生的任何临床症状和随访，以评价两种疫苗的安全性。结果HepA—I组受试者再免疫1个月后，Anti—HAV阳性[≥20毫国际单位（mIU）／毫升（ml）]率由免疫前的95．1％上升到100．0％，几何平均浓度（Geometric Mean Concentration，GMC）由免疫前的124．41mIU／ml上升到7269.31mIU／ml，增长55．74倍。HepAB—I组，Anti—HAV阳性率由免疫前的88．8％上升到98．9％，GMC由免疫前的98．03mIU／ml上升到5174．76mlU／ml，增长58．35倍。HepAB—I组Anti—HBs阳性[≥10mIU／m1]率由免疫前的72．9％上升到97．8％；GMC由免疫前的22．20mlU／ml上升到1226．14mIU／ml，增长54．49倍。此次试验共观察到12例不良反应，均为发热，发生率为5．7％；未发现其他不良反应。结论在健康幼儿再免疫1剂HepA—I、HepAB—I后，血清学效果和安全性良好。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 评价不同细胞基质制备的肠道病毒71型（EV71）灭活疫苗上市后常规免疫安全性。 方法 EV71灭活疫苗疑似预防接种异常反应（AEFI）数据来源于中国免疫规划信息管理系统，为2017年接种EV71 灭活疫苗后江苏省报告的监测数据；受种儿童人口学信息和接种剂次数来源于江苏省预防接种信息管理系统。 结果 2017年江苏省共接种EV71灭活疫苗316 889剂，报告AEFI 208例，报告发生率为65.64/10万剂（95% CI ：56.72/10万剂～74.56/10万剂），其中一般反应55.54/10万剂（95% CI ：47.34/10万剂～63.74/10万剂），异常反应 7.89/10万剂（95% CI ：4.80/10万剂～10.98/10万剂）；不同细胞基质的疫苗AEFI发生率（χ 2 =35.61， P ＜0.01）和一般反应发生率（χ 2 =34.09， P ＜0.01）差异有统计学意义，异常反应发生率差异无统计学意义（χ 2 =1.88， P =0.17），均未见严重异常反应，208例AEFI均未住院且均痊愈。EV71灭活疫苗（Vero细胞）首剂接种一般反应发生率高于第二剂（χ 2 =6.94， P ＜0.01），不同季度接种EV71灭活疫苗（人二倍体细胞）一般反应发生率差异有统计学意义（χ 2 =18.86， P ＜0.01）。 结论 不同细胞基质的EV71灭活疫苗在常规免疫接种中AEFI发生率均不高，有良好的安全性；一般反应以发热为主，异常反应以过敏性-荨麻疹、过敏性皮疹和过敏性斑丘疹等过敏性反应为主。
文摘目的评价甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine，Inactivated；HepA—I）和甲乙型肝炎联合灭活疫苗（Hepatitis A and B Combined Vaccine，Inactivated；HepAB—I）一剂再免疫的血清学效果和安全性。方法采用开放式临床研究设计，选择210名已经完成乙型肝炎（乙肝）疫苗（Hepatitis B Vaccine，HepB）全程免疫、且接种甲肝减毒活疫苗（Hepatitis A Attenuated Live Vaccine，HepA-L）≥6个月的24-38月龄儿童，分为2个试验组，分别接种1剂HepA—J和HepAB—I，并在免疫前和免疫后1个月，对受试者采血检测抗甲肝病毒抗体（Antibodyto Hepatitis A Virus，Anti—HAV）与抗乙肝病毒表面抗原抗体（Antibodvto Hepatitis B Virtus Surface Antigen，Anti-HBs），并对受试者连续3d测体温，并观察可能发生的任何临床症状和随访，以评价两种疫苗的安全性。结果HepA—I组受试者再免疫1个月后，Anti—HAV阳性[≥20毫国际单位（mIU）／毫升（ml）]率由免疫前的95．1％上升到100．0％，几何平均浓度（Geometric Mean Concentration，GMC）由免疫前的124．41mIU／ml上升到7269.31mIU／ml，增长55．74倍。HepAB—I组，Anti—HAV阳性率由免疫前的88．8％上升到98．9％，GMC由免疫前的98．03mIU／ml上升到5174．76mlU／ml，增长58．35倍。HepAB—I组Anti—HBs阳性[≥10mIU／m1]率由免疫前的72．9％上升到97．8％；GMC由免疫前的22．20mlU／ml上升到1226．14mIU／ml，增长54．49倍。此次试验共观察到12例不良反应，均为发热，发生率为5．7％；未发现其他不良反应。结论在健康幼儿再免疫1剂HepA—I、HepAB—I后，血清学效果和安全性良好。
