Bernstein D I, Smith V E, Schiff G M, Rathfon H M, Boscia J A
James N. Gamble Institute of Medical Research, Cincinnati, OH 45219.
Pediatr Infect Dis J. 1993 Feb;12(2):131-5. doi: 10.1097/00006454-199302000-00005.
The safety and immunogenicity of a booster dose of a new acellular pertussis component diphtheria-tetanus toxoids-pertussis vaccine (DTaP) were compared with whole cell pertussis component diphtheria-tetanus toxoids-pertussis vaccine (DTwP). Fifty children ages 15 to 18 months and 50 children ages 4 to 6 years were studied. The incidence of adverse reactions observed during the first 72 hours after vaccination in the DTaP/DTwP vaccinees were: pain, 32%/92% (P < 0.001); redness, 14%/24% (P = 0.2); swelling, 2%/14% (P < 0.03); fever, 52%/90% (P < 0.001); drowsiness, 14%/34% (P < 0.05); fussiness, 32%/88% (P < 0.001); and unusually poor appetite, 6%/42% (P < 0.001). The geometric mean titers of anti-pertussis toxin and anti-filamentous hemagglutinin antibody were also significantly (P < 0.001) higher in the DTaP compared to the DTwP recipients. When administered as a booster dose this DTaP vaccine, which has been chosen by the NIH for the second pertussis vaccine clinical efficacy trial, was more immunogenic for pertussis toxin and filamentous hemagglutinin and caused fewer and less severe adverse reactions compared with the Connaught DTwP vaccine used in this study.
将新型无细胞百日咳组分白喉破伤风类毒素百日咳疫苗（DTaP）加强剂量的安全性和免疫原性与全细胞百日咳组分白喉破伤风类毒素百日咳疫苗（DTwP）进行了比较。研究了50名15至18个月大的儿童和50名4至6岁的儿童。DTaP/DTwP疫苗接种者在接种后72小时内观察到的不良反应发生率为：疼痛，32%/92%（P<0.001）；发红，14%/24%（P=0.2）；肿胀，2%/14%（P<0.03）；发热，52%/90%（P<0.001）；嗜睡，14%/34%（P<0.05）；烦躁，32%/88%（P<0.001）；以及食欲异常减退，6%/42%（P<0.001）。与DTwP疫苗接种者相比，DTaP疫苗接种者的抗百日咳毒素和抗丝状血凝素抗体的几何平均滴度也显著更高（P<0.001）。作为加强剂量使用时，这种被美国国立卫生研究院选用于第二项百日咳疫苗临床疗效试验的DTaP疫苗，与本研究中使用的康诺特DTwP疫苗相比，对百日咳毒素和丝状血凝素的免疫原性更强，且引起的不良反应更少、更轻。
