新生儿接种流感嗜血杆菌乙型肝炎偶联疫苗(COMVAX^(TM))的安全性和免疫效果研究  

Safety and immunogenicity study on infants with COMVAX^(TM)

作　　者：吴晓音[1] 李亚楠[1] 李艳萍[1] 梁争论[1] 石继春[1] 叶强[1] 张华远[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《微生物学免疫学进展》2001年第3期27-29,共3页Progress In Microbiology and Immunology

摘　　要：将出生时接种过重组酵母乙肝疫苗的 131名HBsAg阴性母亲的新生儿 ,随机分为两组 ,一组接种COM VAXTM,另一组接种单价乙肝疫苗和单价流感嗜血杆菌偶联疫苗 ,出生时第一针乙肝疫苗接种后 ,应用 2、4、13月程序免疫。在 2、4月免疫后 ,接种COMVAXTM组和对照组新生儿中无一例发生重度副反应。接种COMVAXTM 组新生儿第一针免前 (2月 )和二针免后一个月 (5月 )的抗 HBs阳转率分别为 5 3 73 %和 95 0 0 % ,抗体GMT分别为10 4 10和 5 6 2 9,均与接种单价组无显著差异。第二针免后一个月接种COMVAXTM组 96 0 0 %新生儿抗 PRP抗体达到长期保护临界值 (1 0 μg/ml)水平 ,而接种单价流感嗜血杆菌疫苗组新生儿为 95 2 0 %。结果表明 ,对于健康母亲所生的新生儿 ,接种COMVAXTM疫苗 ,抗 HBs和抗 PRP抗体阳转率及滴度均不低于接种单价疫苗组。infants who were born from HBsAg negative mothers received yeast derived hepatitis B vaccine at birth and randomly divided into two groups,one group injected with COMVAX TM (lot number:907H)and the other with hepatitis B vaccine and Haemophilus influenzae type b(Hib)conjugate vaccine(lot number:W5022,MSD),according the profocol for 2,4,13 months.No serious side effect were found COMVAX TM group and control group after 2 and 4 months injections.The anti HBs seroconversion rates of COMVAX TM group before the first dose COMVAX TM (2 months)and one month after the second dose(5 months)were 53.73% and 95.00%,and the anti HBs GMT were 104.10 and 56.29,respectively which were the same as that of infants,received yest derived hepatitis B vaccine.96.00% and 95.20% of infants of COMVAX TM group and Hib group anti PRP reached protective value level(1.0 μg/ml),one month after second infection.This results showed that the anti HBs seroconversion rates,GMT and anti PRP of the COMVAX TM group were not less than those from received single valency vaccine group.

关 键 词：重组酵母乙肝疫苗 b型流感嗜血杆菌偶联疫苗 安全性 免疫效果 新生儿 接种 

分 类 号：R392-33[医药卫生—免疫学]