吸附精制百日咳菌苗、白喉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 combined Vaccine

在陕西省大荔县三个村222名4～6岁健康儿童中进行吸附精制百日咳菌苗。白喉类毒素混合制剂加强免疫。结果显示,新一代的吸附精制百、白混合制剂接种后没有出现局部硬结反应,而老百、白混合制剂则出现3例,占接种人数的2.86％。血清学测定,新百、白混合制剂接种后产生的四种免疫抗体水平,其中百日咳凝集素水平免后较免前升高33倍、抗LPF抗体升高468倍、抗FHA抗体升高104倍、抗白喉抗体分布于1.0～8.0HAU/ml之间,≥1.0HAU/ml者为100％。上述四种抗体用平均超过抗百日咳和抗白喉感染的保护水平,说明新研制的吸附精制百、白混合制剂是对人体接种反应轻微、免疫效果良好的优质制剂。

An observation on immunization reaction and serological effect of Adsorbed Purified Pertussis-Diphtheria combined Vaccine for the first time in China had been carried ou in Shangxi. Field trial showed that the Adsorbed Purified Pertussis-Diphtheria combined vaccine manifested trivial reaction, none developed moderate and severe temperature reaction (38.1 - 39℃ and 39.1℃ ) occurred in1 13 children after3doses. Whereas, 0.92% person-times of moderate reaction occurred afrer receiving the Whole cell Pertussis-Diphtheria combined vaccine. Both the Adsorbed Purificd Pertussis-Diphtheria combined vaccine and the Whole cell Pertussis-Diphtheria combined vaccine showed no local moderate, severe and induration reaction; amony mild local reaction, Adsorbed Purified Pertussis-Diphtheria-combined vaccine showed 1 (0.44%) person-time, Whole cell Pertussis-Diphtheria combined vaccine showed 5 (2.29%) person-times, none showed mild induration reaction (0.6-2.5cm)after receiving the Whole cell Pertussis-Diphtheria Combined vaccine, and no mildinduration reaction occurred after receiving the Adsorbed Purified Pertussis-Diphtheria combined vaccinc, whereas, 3 ( 2,86% ) person-times of mild induration reaction occurred after receiving the Whole cell Pertussis-Diphtheria Combined vaccine. Satisfectory immunogenicity of the Adsorbed Purified Pertussis-Diphtheria combined vaccine was confirmed. the high serum hemagglutinin titer was achieved in 100 children, the GMT reached 363.70(11.03 for preimmunization ) , and titers reaching 1:320 and over accounted for 76.23%. The average levels of anti-LPF and anti-FHA antibodies attained to 79.69 ± 24.00 EU/ml ( 0.17 ±0.04 EU/ml for preimmunization ) and 373.06± 87.33EU/ml ( 3.58± 1.94 EU/ml for preimmunization), respectively. The high serum Diphtheria antitoxin were also achieved, the GMT reached 3.631 HAU/ml ( 0.724 for preimmunization, >1.0 HAU/ml was 100% ) .