吸附无细胞百日咳-白喉-破伤风联合疫苗的安全性及免疫原性研究

The Safety and Immunogenicity of the Absorbed Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine

目的评价北京天坛生物制品股份有限公司生产市售的吸附无细胞百日咳一白喉一破伤风联合疫苗（Absorbed Diphtheria,Tetanusand Acellular Pertussis Combined Vaccine；DTaP），在儿童中应用的安全性和免疫原性。方法在浙江省4个县（市、区），选择3235名3～5月龄的初次免疫儿童和3198名18～23月龄加强免疫儿童，按照免疫程序接种此次观察的DTaP，进行接种后安全性观察。采用间接血凝试验（Indirect Hemagglutination Test，IHA）测定白喉、破伤风抗体（Antibodyto Diphtheria，Anti—D；Antibody to Tetanus，Anti—T），采用酶联免疫吸附试验（Enzyme．1inked Immunosorbent Assay，ELISA）检测抗百日咳毒素抗体（Antibody to Pertussis Toxin，Anti—PT）、抗丝状血凝素抗体（Antibodyto Filamentous Hemagglutinin，Anti—FHA），计算抗体阳转率。结果此次DTaP基础免疫共观察9560剂次，加强免疫3198剂次。基础免疫和加强免疫的不良反应发生率分别为6．31％和14．57％，以轻度反应最多，未见严重不良反应及新的、罕见的不良反应。基础免疫3剂后，Anti-D、Anti—T阳转率均达100％，Anti-FHA和Anti-PT阳转率分别为46．02％和95．58％；加强免疫后Anti—D、Anti-T阳性率100％，Anti-FHA和Anti-PT阳性率分别为80．53％和90．27％。结论此次观察的DTaP有良好的安全性；基础免疫和加强免疫后，Anti-D、Anti—T阳转率和Anti—PT阳转率均达到较高水平，但Anti—F-HA阳转率不高。

Objective To evaluate the safety, serological and epidemiological effect of the absorbed diphtheria, tetanus and aeellular pertussis combined vaccine （DTaP）. Methods 3235 3-5 months old children who were primary immunized and 3198 18-23 months old children who were booster immunized were selected. All children were observed for Adverse Events Following Immunization （AEFI） after vaccination. Indirect Hemagglutination Test （IHA） was used for Diphtheria and Tetanus antibody test while Enzyme-linked Immunosorbent Assay （ELISA） was used for Pertussis Toxin and Filamentous Hemagglutinin antibody test. Antibody conversion rate was calculated as well. Results The over all rate of adverse events was 6.31% and 14.57% among primary immunization （9560 doses totally） and booster immunization （3198 doses） respectively. Most adverse events were minor reaction. Severe, rare or new adverse events were not reported. The positive conversion rate of antibody to Diphtheria and Tetanus （Anti-D, Anti-T） were 100% respectively among primary immunizations. The positive conversion rate of antibody to filamentous hemagglutinin （Anti-FHA） and antibody to pertussis toxin （Anti-PT） were 46.90% and 95.58% in primary immunizations. The positive conversion rate of Anti-D and Anti-T were 100% among booster immunizations. The Anti-FHA and Anti-PT were 80.53%0 and 90.27% in booster immunization. Conclusion The DTaP vaccine was safe and effective. The positive conversion rate of Anti-D, Anti-T and Anti-PT were in high level but without the Anti-FHA.