白喉-破伤风-无细胞百日咳-脊髓灰质炎灭活疫苗的临床免疫原性研究进展(续)

Progress in development on clinical immunogenicity of diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (continued)

目前,国内许多疫苗生产厂家都在致力于研制以白喉-破伤风-无细胞组分百日咳疫苗(diphtheria,tetanus,acelluar component pertussis vaccine,DTacP)为基础的联合疫苗,而国外不同厂家该类联合疫苗在临床试验中的免疫后抗体检测方法和保护性评判标准有较大差异。此文旨在通过比较不同DTacP-脊髓灰质炎灭活疫苗的临床免疫原性结果,包括血清保护率/血清阳转率和不同方法测定的抗体几何平均滴度,为临床试验方案设计提供依据和思路。

At present, many vaccine manufacturers in China are focusing on the development of combined vaccines based on diphtheria, tetanus, acellular component pertussis vaccine (DTacP). There are great differences in antibody detection methods and protective evaluation criteria in clinical trials of different manufacturers abroad.This paper is aimed to provide experimental evidence and ideas for the design protocol of clinical trial by comparing the immunogenicity results of different DTacP-inactivated poliovirus vaccines, including seroprotection/seroconversion rates and geographic mean titers measured by various detection methods.