摘要
为评价倍尔来福TM甲、乙型肝炎联合疫苗在成人中应用的安全性和免疫原性 ,在广西壮族自治区和河北省以16～ 2 0岁中学生为研究对象 ,按抗甲型肝炎 (甲肝 )病毒抗体 (抗 HAV )和乙型肝炎 (乙肝 )病毒 (HBV)感染 5项指标均阴性 ,抗 HAV阴性和HBV感染 5项指标阴性或阳性 ,HBV感染 5项指标阴性、抗 HAV阴性或阳性 ,分为AB组、A组和B组 ,按 0、1、6个月程序分别接种甲、乙型肝炎联合疫苗 ,甲肝灭活疫苗和重组 (酵母 )乙肝疫苗。疫苗剂量为每剂含HAV抗原 5 0 0U和乙肝病毒表面抗原 10 μg。观察接种疫苗后 72h内局部反应和全身反应 ,检测免疫后 2个月和7个月的血清抗 HAV阳转率、乙肝病毒表面抗体 (抗 HBs)保护率及抗体滴度。结果表明 :AB组局部副反应主要为—过性疼痛 ,全身副反应以低热为主 ,并在 72h内自行恢复。免疫后 7个月 ,AB组与A组抗 HAV阳转率均为 10 0 % ;几何平均滴度 (GMT)分别为 2 2 6 6 3mIU/ml和 2 3311mIU/ml;抗 HBs保护率AB组和B组分别为 97 71%和 96 89% ;GMT分别为 10 7mIU/ml和 97mIU/ml,两组阳转率、保护率及GMT差异均无显著的统计学意义。因此 ,在成人中应用甲、乙型肝炎联合疫苗与单价甲肝灭活疫苗和单价重组 (酵母 )乙肝疫苗具有相同的安全性和免疫原性。
To evaluate the safety and immunogenicity of a combined hepatitis A and hepatitis B-Bilive TM vaccine in healthy adult volunteers in Guangxi province and Hebei province of China,adult volunteers were selected from 16 year-old to 20 year-old students of a senior high school.Those who were susceptible to both HAV and HBV,HAV only and HBV only were assigned to group AB,A and B,respectively,who were then vaccinated with three doses(0,1 and 6 month schedule)of combined hepatitis A and B vaccine,respectively.The dosage was 500U for hepatitis A antigen and 10μg for hepatitis B surface antigen.The potential adverse effects were observed within 72 hours after vaccination.The serum samples were collected for the testing of anti-HAV and anti-HBs at month 2 and 7 after initial dose.The local and systemic adverse reactions after the primary immunization and the booster immunization were slight and temporary in AB group;the systemic adverse effect was low fever.Both of local and systemic adverse effects were disappeared without treatment within 72 hours.The sero-conversion rate of HAV in AB and A group was 100% one month after 3 doses;the GMT was 22 663 mIU/ml and 23 311mIU/ml respectively.The sero-conversion rate of HBV in AB and B group was 97.71% and 96.89% one month after 3 doses;the GMT was 107mIU/ml and 97mIU/ml respectively.There was no statistically significant difference on sero-conversion rate and GMT among combined group and control groups.Therefore,it has the same safety and immunogemicity to apply the combined hepatitis A and B vaccine to volunteers as compared to mono- valent inativated HA vaccine and recombinant yeast-derived monovalent HB vaccine.
出处
《中国计划免疫》
2004年第3期129-132,共4页
Chinese Journal of Vaccines and Immunization
关键词
甲、乙肝联合疫苗
安全性
免疫原性
A combined hepatitis A and hepatitis B vaccine
Safety
Immunogenicity
