Zaĭtsev E M, Poddubikov A V, Britsina M V, Mertsalova N U, Bazhanova I G, Ozeretskovskaia M N, Nazirov M P, Mazurova I K, Petrova M S, Popova O P, Zakharova N S
Zh Mikrobiol Epidemiol Immunobiol. 2009 Nov-Dec(6):76-9.
To assess antigenic composition consistency and serological characteristics of domestic acellular pertussis vaccine.
Amount of pertussis toxin, filamentous hemagglutinin, agglutinogens types 1, 2, and 3 in experimental batches of vaccine was measured by enzyme immunoassay. Levels of antibodies to aforementioned antigens as well as to lipopolysaccbaride in serum samples obtained from patients with pertussis and healthy vaccinated children were measured by the same method. The amount of lypopolysaccharide was determined by LAL test.
Studied batches of vaccine were standard on amount of all protein antigens as well as lipopolysaccharide. Spectrum of antibodies to vaccine components in serum samples from patients with pertussis and healthy vaccinated children included antibodies to individual antigens: pertussis toxin, filamentous hemagglutinin, lipopolysaccharide, agglutinogens types 1, 2, and 3.
Developed technology for manufacturing acellular pertussis vaccine allows to consistently produce preparations with standard amount of all components. Vaccine components interact with antibodies to wide spectrum of B. pertussis antigens.
评估国产无细胞百日咳疫苗的抗原组成一致性和血清学特征。
采用酶免疫测定法检测实验批次疫苗中百日咳毒素、丝状血凝素、1、2和3型凝集原的含量。采用相同方法检测百日咳患者和健康接种儿童血清样本中上述抗原以及脂多糖的抗体水平。脂多糖的含量通过鲎试剂法测定。
所研究批次的疫苗在所有蛋白质抗原以及脂多糖含量方面均符合标准。百日咳患者和健康接种儿童血清样本中针对疫苗成分的抗体谱包括针对单个抗原的抗体：百日咳毒素、丝状血凝素、脂多糖、1、2和3型凝集原。
所开发的无细胞百日咳疫苗生产技术能够持续生产出所有成分含量均符合标准的制剂。疫苗成分与针对多种百日咳杆菌抗原的抗体相互作用。
