Black S B, Shinefield H R, Bergen R, Hart C, Kremers R, Lavetter A, Lemesurier J, Morozumi P A, Ray P, Lewis E M, Fireman B, Schwalbe J, Hallam P, Shandling M, Dekker C, Granoff D M, Izu A, Podda A
Pediatric Vaccine Study Group, Kaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Pediatr Infect Dis J. 1997 Jan;16(1):53-8. doi: 10.1097/00006454-199701000-00012.
To evaluate the safety and immunogenicity of the recombinant acellular pertussis-diphtheria-tetanus (aPDT) vaccine (C-aPDT, Chiron/Biocine).
This is a randomized blinded trial evaluating the safety and immunogenicity of the recombinant aPDT vaccine (C-aPDT, Chiron/Biocine) in 2000 infant recipients compared with 498 controls who received whole cell diphtheria-pertussis-tetanus (wDPT; Connaught) vaccine at 2, 4 and 6 months of age. In addition the safety and immunogenicity of the same C-aPDT vaccine were evaluated as a booster dose in a subset of the same population when given at 15 to 18 months of age and compared with licensed Lederle aPDT vaccine.
The C-aPDT vaccine was associated with very few local or systemic reactions when compared with wDPT. In toddlers the local and systemic side effects observed were similar after either acellular vaccine. When the immunogenicity of the C-aPDT vaccine was compared with the wDPT (Connaught) in infancy, the vaccines were equivalent for anti-diphtheria response, the wDPT developed higher anti-tetanus response and the C-aPDT vaccine was significantly more immunogenic for all other antigens tested. In toddlers the C-aPDT acellular vaccine exhibited equal or improved immunogenicity for antigens tested as compared with Lederle aPDT except for a higher anti-filamentous hemagglutinin response with the Lederle aPDT vaccine.
The Chiron/Biocine aPDT vaccine offers an improved safety profile as well as improved immunogenicity when compared with a licensed wDPT product.
评估重组无细胞百日咳-白喉-破伤风（aPDT）疫苗（C-aPDT，Chiron/Biocine）的安全性和免疫原性。
这是一项随机双盲试验，在2000名婴儿接种者中评估重组aPDT疫苗（C-aPDT，Chiron/Biocine）的安全性和免疫原性，并与498名在2、4和6月龄时接种全细胞白喉-百日咳-破伤风（wDPT；Connaught）疫苗的对照组进行比较。此外，在同一人群的一个亚组中，于15至18月龄时给予相同的C-aPDT疫苗作为加强剂量，评估其安全性和免疫原性，并与已获许可的Lederle aPDT疫苗进行比较。
与wDPT相比，C-aPDT疫苗引起的局部或全身反应极少。在幼儿中，两种无细胞疫苗接种后观察到的局部和全身副作用相似。在婴儿期将C-aPDT疫苗的免疫原性与wDPT（Connaught）进行比较时，两种疫苗在抗白喉反应方面相当，wDPT产生的抗破伤风反应更高，而C-aPDT疫苗对所有其他检测抗原的免疫原性明显更强。在幼儿中，与Lederle aPDT相比，C-aPDT无细胞疫苗对检测抗原的免疫原性相同或有所提高，但Lederle aPDT疫苗的抗丝状血凝素反应更高。
与已获许可的wDPT产品相比，Chiron/Biocine aPDT疫苗具有更好的安全性和免疫原性。
