Mills E, Gold R, Thipphawong J, Barreto L, Guasparini R, Meekison W, Cunning L, Russell M, Harrison D, Boyd M, Xie F
McGill University, Montreal, QB, Canada.
Vaccine. 1998 Apr;16(6):576-85. doi: 10.1016/s0264-410x(97)00241-7.
Safety, immunogenicity and lot consistency of five-component pertussis combination vaccine (CPDT-IPV//PRP-T) in infants were compared to that of whole cell pertussis combination vaccine (DPT-IPV//PRP-T), as were separate and combined injections of CPDT-IPV and PRP-T. No significant differences in adverse event rates were observed between lots of CPDT-IPV//PRP-T or between separate or combined injections of CPDT-IPV and PRP-T. Minor differences in antibody responses were observed between lots of component pertussis vaccine. Higher concentrations of diphtheria and tetanus antitoxins were induced by separate than by combined injection of CPDT-IPV and PRP-T, but no other differences in immunogenicity were observed. Adverse reactions were more than twice as frequent after whole cell than after component pertussis vaccines. Antibody responses to pertussis toxoid, filamentous hemagglutin and pertactin were significantly greater after component vaccines, while the response to type 3 poliovirus was higher after whole cell vaccine. No significant differences were observed for other vaccine components. CPDT-IPV//PRP-T was safe and immunogenic in infants. Antibody results were similar to those observed in a Swedish field trial that demonstrated CPDT to be 85% effective in preventing clinical pertussis.
将五组分百日咳联合疫苗（CPDT-IPV//PRP-T）在婴儿中的安全性、免疫原性和批次一致性与全细胞百日咳联合疫苗（DPT-IPV//PRP-T）进行了比较，同时也比较了CPDT-IPV和PRP-T单独注射及联合注射的情况。在CPDT-IPV//PRP-T的不同批次之间，以及CPDT-IPV和PRP-T单独注射或联合注射之间，未观察到不良事件发生率有显著差异。在各批次的组分百日咳疫苗之间观察到抗体反应存在微小差异。与CPDT-IPV和PRP-T联合注射相比，单独注射诱导的白喉和破伤风抗毒素浓度更高，但未观察到其他免疫原性差异。全细胞百日咳疫苗后的不良反应发生率是组分百日咳疫苗后的两倍多。组分疫苗后对百日咳毒素、丝状血凝素和百日咳杆菌黏附素的抗体反应显著更强，而全细胞疫苗后对3型脊髓灰质炎病毒的反应更高。其他疫苗组分未观察到显著差异。CPDT-IPV//PRP-T在婴儿中是安全且具有免疫原性的。抗体结果与在瑞典一项现场试验中观察到的结果相似，该试验表明CPDT预防临床百日咳的有效性为85%。
