| 任银海,陈江婷,吴文婷,公雪杰,张玉成,薛伟华,任一丰,韩连军,康文学,李胜平,刘崇柏.孩尔来福甲型肝炎灭活疫苗0,12个月免疫程序研究[J].Chinese journal of Epidemiology,2003,24(11):1013-1015 |
| 孩尔来福甲型肝炎灭活疫苗0,12个月免疫程序研究 |
| The study on the 0,12 month vaccination schedule' of Healive inactivated hepatitis A vaccine in children |
| Received:March 06, 2003 |
| DOI： |
| KeyWord: 甲型肝炎灭活疫苗 免疫原性 安全性 免疫程序 |
| English Key Word: Inactivated hepatitis A vaccine Immunogenicity Safety Immunization-schedule |
| FundProject:国家“九五”医学科技攻关项目资助(969060304) |
| Author Name | Affiliation | | REN Yin-hai | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | CHEN Jiang-ting | 北京科兴生物制品有限公司 | | WU Wen-ting | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | GONG Xue-jie | 北京科兴生物制品有限公司 | | ZHANG Yu-cheng | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | XUE Wei-hua | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | REN Yi-feng | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | HAN Lian-jun | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | KANG Wen-xue | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | LI Sheng-ping | Health and Antieqidemic Station of Pingshan County, Pingshan 050400, China | | LIU Chong-bai | 中国疾病预防控制中心病毒病预防控制所 |
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| Abstract: |
| 目的对孩尔来福(HealiveR○)甲型肝炎(甲肝)灭活疫苗的安全性、免疫原性及适宜儿童的剂量进行研究。方法在某山区两个农村筛选4～10岁甲肝病毒抗体(抗HAV)阴性的85名易感儿童。以自然村随机分为两组,按0,12个月免疫程序分别接种北京科兴生物制品有限公司生产的每剂250U0.5ml和500U1ml甲肝灭活疫苗,观察免疫后局部反应和全身反应,检测初次免疫(初免)后21天、12个月及全程免疫后1个月抗HAV阳转率和抗体几何平均滴度(GMT)。结果两组均未见严重局部反应和全身反应;250U0.5ml组和500U1ml组初免后21天,抗HAV阳转率分别为94.4%和100.0%,GMT分别为195mIUml和370mIUml;初免后12个月抗HAV全部阳转,GMT分别达361mIUml和456mIUml(P>0.05);全程免疫后1个月,GMT分别达14893mIUml和21696mIUml。结论孩尔来福甲肝灭活疫苗的安全性和免疫原性好;每剂250U0.5ml适宜儿童;0,12个月免疫程序更适宜中国儿童 |
| English Abstract: |
| Objective To evaluate the safety, immunogenicity and fiTdosage of Healive inactivated hepatitis A vaccine( HAV)in children.Methods A total of 85 susceptible aged 4-10 years with HAV seronegative children, had been enrolled from two adjacenTvillages in a county.The volunteers were randomized allocated into two groups and toreceive a priming dose of 250 U 0. 5 ml dose or 500 U 1. 0 ml dose of Healive vaccine, produced by Sinovac Biotech Co, Ltd.A booster of the same dose was given aT12th month.Local and systemic side effects were examined and seroconversion rate as well as geometric mean titers of anti-HAvantibody were tested aT3-week, 12-month after the primary dose and aT1 month after the booster dose.Results The vaccine was well tolerated in both groups.AT21 days after the primary dose, the seroconversion rates were 94. 4%, 100. 0% and geometric mean titers( GMT)were 195 mIU ml and 370 mIU ml in 250 U and 500 U groups respectively. AT12 months after the primary dose, the seroconversion rate of anti-HAV was 100. 0%, and GMTraised to 361 mIU ml, 456 mIU ml ( P > 0. 05)respectively.One month after the booster dose, GMTraised to 14 893 mIU ml, 21 696 mIU ml. Conclusion GM Tof the 0, 12 month schedule was higher than other schedule after the booster vaccination.The HealiveR inactivated vaccine can be used for emergency vaccination.The HealiveR inactivated vaccine produced by Sinovac Company Ltd was safe and highly immunogenic. Two hundred and fifty U dose was considered appropriate for children. |
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