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作者对两种百日咳无细胞菌苗(APV)进行了研究。小剂量APV含百日咳类毒素(PT)10μg,丝状血凝素(FHA)5μg,菌毛抗原(FIM,凝集原2和3)5μg,69kDa蛋白3μg,白喉类毒素(DIP)15絮状反应单位(Lf),破伤风类毒素(TET)5Lf。大剂量APV含PT和FHA各20μg,其他成份含量相同。用随机双盲法对8个地区2050名婴儿进行初免。为了对大剂量抗原提供足够的安全性资料,婴儿人数分配比例按大剂量APV组:小剂量APV组=6:1。
The authors studied two B. pertussis acellular vaccine (APV). The low dose APV contained 10 μg of pertussis toxoid (PT), 5 μg of filamentous hemagglutinin (FHA), 5 μg of pilus antigen (FIM, agglutinogens 2 and 3), 3 μg of 69 kDa protein, DIP 15 flocculation Unit (Lf), tetanus toxoid (TET) 5Lf. High-dose APV containing PT and FHA each 20μg, other ingredients the same content. A randomized double-blind trial of 2050 infants in eight districts was performed. In order to provide enough safety information for high-dose antigens, the proportion of infants allocated to high-dose APV group: low-dose APV group = 6: 1.