Aoyama T, Murase Y, Kato M, Iwai H, Iwata T
Department of Pediatrics, Keio University, School of Medicine, Tokyo, Japan.
Am J Dis Child. 1989 Jun;143(6):655-9. doi: 10.1001/archpedi.1989.02150180033015.
Acellular pertussis vaccines, which have been used in Japan since 1981, vary in antigenic constituents among manufacturers. First, to assess the immunogenicity by manufacturer and patient age, 161 children aged 3 months to 2 years were immunized by acellular pertussis vaccine from one of three Japanese manufacturers, Biken, Takeda, or Kitasato. Anti-pertussis toxin antibody responses for children immunized with Takeda and Kitasato vaccines were comparable with patients with pertussis in the convalescent stage, and anti-pertussis toxin antibody response for Biken vaccine was far higher than those of convalescing patients. Anti-filamentous hemagglutinin antibody responses for the children given the three vaccines were far higher than those of the patients. Weak serotype 1.3 agglutinin responses were observed only in children administered the Takeda vaccine. Comparing these antibody responses among various age groups, the immunogenicity of acellular vaccines in children aged 3 to 6 months was comparable with children aged 2 years. Second, to assess the manufacturer-specific efficacy, 495 households of patients with pertussis were surveyed from 1981 to 1988. The estimated efficacy of the acellular pertussis vaccines in children aged 2 to 8 years was 82%, and there were no major differences in the secondary attack rates among children immunized with acellular pertussis vaccine from each manufacturer, ie, 12.5% (1/8) for Biken, 11.1% (2/18) for Takeda, and 5.9% (1/17) for Kitasato. We conclude from these two studies that similar efficacy was observed in children aged 2 years or older for acellular pertussis vaccines from the three manufacturers, which produced anti-pertussis toxin antibody responses comparable with patients with pertussis and far higher antifilamentous hemagglutinin antibody responses than in the convalescing patients, and that age did not affect the immunogenicity of acellular vaccines.
自1981年起在日本使用的无细胞百日咳疫苗，不同制造商生产的疫苗其抗原成分有所不同。首先，为评估不同制造商生产的疫苗以及不同年龄患儿的免疫原性，选取了161名年龄在3个月至2岁之间的儿童，分别接种了来自日本三家制造商（北里研究所、武田制药、日本生物制品研究所）之一生产的无细胞百日咳疫苗。接种武田制药和北里研究所生产疫苗的儿童，其抗百日咳毒素抗体反应与处于恢复期的百日咳患者相当，而接种日本生物制品研究所疫苗的儿童，其抗百日咳毒素抗体反应远高于处于恢复期的患者。接种这三种疫苗的儿童，其抗丝状血凝素抗体反应均远高于百日咳患者。仅在接种武田制药疫苗的儿童中观察到微弱的1.3型血清凝集素反应。比较不同年龄组之间的这些抗体反应发现，3至6个月龄儿童接种无细胞疫苗的免疫原性与2岁儿童相当。其次，为评估不同制造商生产的疫苗的特异性效力，在1981年至1988年期间对495户百日咳患者家庭进行了调查。估计无细胞百日咳疫苗对2至8岁儿童的效力为82%，不同制造商生产的无细胞百日咳疫苗免疫儿童的继发感染率无显著差异，即日本生物制品研究所生产的疫苗为12.5%（1/8），武田制药生产的疫苗为11.1%（2/18），北里研究所生产的疫苗为5.9%（1/17）。从这两项研究中我们得出结论，对于三家制造商生产的无细胞百日咳疫苗，在2岁及以上儿童中观察到了相似的效力，这些疫苗产生的抗百日咳毒素抗体反应与百日咳患者相当，且抗丝状血凝素抗体反应远高于处于恢复期的患者，并且年龄并未影响无细胞疫苗的免疫原性。
