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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Comparison of diphtheria-tetanus-two component acellular pertussis vaccines in United States and Japanese infants at 2, 4, and 6 months of age.
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Comparison of diphtheria-tetanus-two component acellular pertussis vaccines in United States and Japanese infants at 2, 4, and 6 months of age.

机译：美国和日本2、4、6个月大婴儿的白喉-破伤风-两种成分脱细胞百日咳疫苗的比较。

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OBJECTIVE: We compared the diphtheria and tetanus toxoids and bicomponent acellular pertussis vaccine (DTaP) responses in Japanese and United States infants. DESIGN: This was a double-blind, comparative study. SETTING: Private pediatric practices in Japan and the U.S. participated. SUBJECTS: One hundred eighty-nine healthy 2-month old infants were tested. INTERVENTIONS: Infants were immunized at 2, 4, and 6 months of age. The Japanese formulation (DTaP-J) contained 20 micrograms of pertussis toxin (PT) and 20 micrograms of filamentous hemagglutinin (FHA); the U.S. formulation (DTaP-US) contained 23.4 micrograms of each antigen. Parents used a standard form to record average adverse experiences. Serum was obtained before the first immunization, 2 months after the second immunization, and 1 month after the third immunization. MEASUREMENTS: Differences in DTaP-J and DTaP-US were evaluated in Japanese infants immunized subcutaneously (s.c.). Differences due to ethnicity and to route of administration were compared in U.S. infants immunized with DTaP-US s.c. or intramuscularly (i.m.). An indirect enzyme-linked immunosorbent assay was used to determine immunoglobulin G antibody responses to PT, FHA, and tetanus toxoid. Neutralizing antibody to PT was measured by a Chinese hamster ovary call assay. Diphtheria antitoxin was assayed by serum neutralization on VERO cells. RESULTS: Statistical differences (P < .05) in adverse events included less fatigue after immunization with DTaP-US compared with DTaP-J. Erythema of more than 2.5 cm was more frequent, but erythema less than 2.5 cm was less frequent in Japanese infants compared with U.S. infants. Fewer Japanese infants were febrile ( > 38 degrees C), tired, or irritable. Subcutaneous immunization resulted in a greater frequency of erythema and induration. The DTaP-US resulted in an equivalent response to PT and a greater response to FHA. More Japanese infants demonstrated at least a fourfold response over preimmunization antibody values to FHA. In U.S. infants, antibody responses to the contained pertussis antigens were equivalent after i.m. and s.c. administration. Compared with Japanese infants receiving DTaP-J s.c., U.S. infants receiving DTaP-US i.m. had equivalent responses to PT and a greater response to FHA. CONCLUSIONS: United States infants receiving an i.m. injection of a U.S. -produced bicomponent DTaP vaccine produced antibody responses to the contained pertussis antigens at least equal to those of Japanese infants receiving a similar bicomponent DTaP vaccine shown to be effective in older Japanese children.
机译：目的：我们比较了日本和美国婴儿的白喉和破伤风类毒素及双组分无细胞百日咳百日咳疫苗（DTaP）的反应。设计：这是一项双盲比较研究。地点：日本和美国的私人儿科医师参加了活动。研究对象：189名2个月大健康婴儿。干预措施：在2、4和6个月大时对婴儿进行了免疫。日本制剂（DTaP-J）含有20微克的百日咳毒素（PT）和20微克的丝状血凝素（FHA）;美国制剂（DTaP-US）包含23.4微克的每种抗原。父母使用标准表格记录平均不良经历。在第一次免疫前，第二次免疫后2个月和第三次免疫后1个月获得血清。测量：在日本皮下免疫接种的婴儿中评估了DTaP-J和DTaP-US的差异（s.c.）。在美国接受DTaP-US s.c.免疫的婴儿中，比较了由于种族和给药途径引起的差异。或肌肉内（i.m.）。间接酶联免疫吸附试验用于确定免疫球蛋白G抗体对PT，FHA和破伤风类毒素的反应。通过中国仓鼠卵巢检定法测量抗PT的中和抗体。通过在VERO细胞上的血清中和来测定白喉抗毒素。结果：不良事件的统计学差异（P <.05）包括DTaP-US免疫后的疲劳少于DTaP-J。与美国婴儿相比，日本婴儿中红斑超过2.5厘米的频率更高，但低于2.5厘米的红斑的频率更低。较少的日本婴儿发烧（> 38摄氏度），疲倦或易怒。皮下免疫导致红斑和硬结的频率更高。 DTaP-US对PT的反应相同，对FHA的反应更大。更多的日本婴儿表现出超过针对FHA的免疫前抗体值至少四倍的反应。在美国婴儿中，在下午2点后，对所含百日咳抗原的抗体反应是相同的。和s.c.行政。与接受DTaP-J s.c.的日本婴儿相比，美国接受DTaP-US i.m.婴儿。对PT的反应相同，对FHA的反应更大。结论：美国婴儿接受I.m.注射美国生产的双组分DTaP疫苗可产生对所含百日咳抗原的抗体反应，至少相当于接受类似双组分DTaP疫苗的日本婴儿对日本大龄儿童有效。

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