吸附无细胞百日咳菌苗、白喉、破伤风类毒素混合制剂Ⅲ期临床人体接种反应和血清学效果观察报告  

A Phase Ⅲ clinical trial on immunization reaction and serological effect of adsorbed acellular pertussis vaccine-diphtheria and tetanus toxoid combined vaccine

作　　者：何长民[1] 陈爱荣[1] 陈平纡[1] 杨晓明[1] 王祖森[1] 秦力[1] 孙述学[1] 秦进才[2] 侯启明[2] 张路民[2] 王立兰[2] 田霖[2] 雷殿良[2] 吴承民[3] 何由成[3] 姚稳成 武蕊元 赵礼清 

机构地区：[1]卫生部兰州生物制品研究所 [2]中国药品生物制品检定所 [3]广东省卫生防疫站 [4]陕西省大荔县卫生防疫站

出　　处：《微生物学免疫学进展》1998年第4期25-28,共4页Progress In Microbiology and Immunology

摘　　要：吸附无细胞百、白、破混合制剂（ＤＴａｃＰ）于１９９５年６月至１９９７年９月在广东省４个市和陕西省大荔县进行了Ⅲ期临床人体接种反应和血清学效果观察，全程基础免疫婴幼儿６４９６１例，加强注射３８８６０例，总计为１０３８２１例，接种反应轻微，未发现有严重异常反应者。ＤＴａｃＰ在基免后１年和加强注射前抗ＰＴ和抗ＦＨＡ的抗体水平分别为１０１ＥＵ／ｍｌ和５１３ＥＵ／ｍｌ；加强注射后１个月，抗ＰＴ和抗ＦＨＡ的抗体水平显著增长，分别为２４３４ＥＵ／ｍｌ和３１１３ＥＵ／ｍｌ；加强免疫后１年，抗ＰＴ和抗ＦＨＡ的抗体水平均能维持在较高的抗感染水平，分别为２０１ＥＵ／ｍｌ和５８６ＥＵ／ｍｌ；ＤＴａｃＰ抗白喉和抗破伤风的抗体水平，不论是在基免后还是在加强注射后１个月或１年，其≥００１ＨＡＵ／ｍｌ的例数均为１００％，均显著超过儿童抗白喉和抗破伤风感染要求的保护水平（００１ＨＡＵ／ｍｌ）。A phase Ⅲ clinical trial on immunization reaction and serological effect of Adsorbed Acelluler Pertussis vaccine-Diphtheria and Tetanus Toxoid Combined Vaccine (DTacP) had been carried out in Guangdong and Shanxi.The results of phase Ⅲ field trial showed that the DTacP manifested trivial reaction,none developed local reaction and severe temperature reaction occurred in 64961 children after recieving 3 doses and in 38860 children after recieving 1 booster dose.Satisfactory immunogenicity of the DTacP was confirmed.Titers of agglutinin above 1∶320 in 70 children after receiving booster dose 1 month accounted for 71^43%.The average level of anti-LPF and anti-FHA antibodies after recieving 3 doses 1 year were 10.1EU/ml and 51.3EU/ml respectively,and after recieving booster dose 1 month attained to 243.4EU/ml and 311.3EU/ml respectively,after recieving booster dose 1 year were 20.1EU/ml and 58.6EU/ml respectively.The high serum Diphtheria and Tetanus antitoxin were also achieved,after immunized 3 doses with DTacP 1 year or after recieving booster dose 1 month and 1 year,both the ≥0.01HAU/ml cases of antibodies were 100%.

关 键 词：百日咳菌苗 白喉 破伤风类毒素 破伤风抗体 

分 类 号：R392-33[医药卫生—免疫学]