吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂人体接种反应和血清学效果观察报告  

An Observation on immunization Reaction and Serological Effect of Adsorbed Purified Pertussis-Diphtheria-Tetanus Combined Vaccine

作　　者：He Changming, Pen Youyuan, Qin Jingcai, Yang Chaoen et al Lanzhou Institute of Biological Products Ministry of Public Health 

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

出　　处：《微生物学免疫学进展》1993年第3期6-17,共12页Progress In Microbiology and Immunology

摘　　要：在陕西省大荔县所辖的五个乡(镇)、二个工厂319名3～6月龄婴幼儿中进行吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂人体接种反应及血清学效果观察。从人体接种反应观察结果中看出,新研制的吸附精制百、白、破混合制剂的全身反应中没有出现中、强反应,而老百、白、破混合制剂则出现中反应9例(占接种人数的8.6％)、强反应2例(占0.92％);局部反应中前者中反应1例(占0.96％),后者为10例(占9.28％);局部硬结反应中,前者没有出现中、强反应,而后者出现5例(占4.58％)。说明新研制的吸附精制百、白、破混合制剂的接种反应极为轻微,安全性上明显地优于老百、白、破混合制剂。血清学测定结果表明,吸附精制百、白、破混合制剂免疫后产生出五种抗体应答,百日咳凝集素水平≥1:320者为73％,免疫后较免疫前增长167.18倍(P<O.01);抗LPF抗体和抗FHA抗体水平分别为52.40EU/ml和131.37EU/ml;抗白喉抗体水平分布于0.01～4.0HAU/ml之间,≥0.01HAU/ml者为100％;抗破伤风抗体水平分布于0.01～16HAU/ml之间,≥0.01HAU/ml者为100％。说明新研制的吸附精制百、白、破混合制剂配方合理,免疫后显示出良好的免疫效果。An observation on immunization reaction and serological effect of Adsorbed Purified Pertussis-Diphtheria-Tetanus combined Vaccine for the first time in China had been Carried out in Shangxi. Field trial showed that the Adsorbed Purified Pertussis-Diphtheria-Tetanus combined Vaccine manifested trivial reaction, none developed moderate or severe temperature reaction(38.1 -39℃ Or 39.1 ℃ ) occurred in 100 children after 3 doses. Whereas, 9 ( 0.94% ) person-times of moderate reaction and 2 person-times of severe temperature reaction occurred after receiving the Whole cell Pertussis-Diphtheria-Tetanus combined Vaccine. None showed local severe reaction(5.1cm) after receiving the Adsorbed Purified Pertussis-Diphtheria-Tetanus combined Vaccine and Whole cell Pertussis-Diphtheria-Tetanus combined Vaccine, and only 1 ( 0.16% ) person-time of moderate local reaction occurred after receiving the Adsorbed Purified Pertussis-Diphtheria-Tetanus combined Vaccine, Whereas, 5 ( 0. 78% ) person-times of moderate local reaction and 5(1.58%) person-times of moderate induration reaction ( 2.6-5.0cm ) occurred after receiving the Whole cell Pertussis-Diphtheria-Tetanus combined Vaccine. Satisfactory immunogenicity of the Adsorbed Purified Pertussis-Diphtheria-Tetanus combined Vaccine was confirmed. The high serum hemagglutinin titer was achieved in 100 children, the GMT reached 187.24(1.12 for pre-immunization ) , and titers reaching 1:320 and over accounted for 73%. The average levels of anti-LPF and anti-FHA antibodies in 56 and 56 persons attained to 52.40 ± 6.50EU/ml ( 0.21 ±0.02 for perimmunization ) and 131.37±17.47EU/ml (0.46 ± 0.30 for preimmunization) , respectively. The High serum Diphtheria and Tetanus antitoxin were also achieved in 89 and 88 persons, the GMT reached 0.509 HAD/ml (0.02 for preimmunization, >0.01 HAU/ml was 100% ) and 2.179 HAU/ml ( 0.007 for preimmunization, >0.01 HAU/ml was 100% ) , respectively.

关 键 词：百日咳 白喉 破伤风 混合菌苗 吸附 

分 类 号：R392－33[医药卫生—免疫学]