Sato Y, Kimura M, Fukumi H
Lancet. 1984 Jan 21;1(8369):122-6. doi: 10.1016/s0140-6736(84)90061-8.
Antibodies against two physicochemically purified haemagglutinins (HAs) of Bordetella pertussis (filamentous HA and leucocytosis-promoting-factor HA) protect laboratory animals from pertussis. A vaccine containing these two HAs was prepared and tested in trials involving about 5000 children. Culture supernatant of Bordetella pertussis, phase I, was treated with ammonium sulphate, and a crude extract of the HAs was extracted from the precipitate by the use of concentrated sodium chloride. This crude extract was fractionated by sucrose density gradient centrifugation to obtain an HA preparation practically free of endotoxin. The HA preparation was treated with formalin to destroy its ability to induce leucocytosis and to cause histamine sensitisation. Aluminium hydroxide was added to the preparation as an adjuvant. The component vaccine is not only potent as judged by the mouse test but is also less than one-tenth as toxic as whole-cell vaccine as judged by leucocytosis promotion, histamine sensitisation, and endotoxicity tests. Field trials showed that component vaccine was as effective as and produced less side-effects than did conventional whole-cell vaccine. The vaccine has been used for mass immunisation in Japan since the autumn of 1981.
针对百日咳博德特氏菌两种经物理化学方法纯化的血凝素（丝状血凝素和促白细胞增多因子血凝素）的抗体可保护实验动物免受百日咳感染。制备了一种含有这两种血凝素的疫苗，并在约5000名儿童参与的试验中进行了测试。对I相百日咳博德特氏菌的培养上清液用硫酸铵处理，然后用浓氯化钠从沉淀物中提取血凝素粗提物。该粗提物通过蔗糖密度梯度离心进行分级分离，以获得几乎不含内毒素的血凝素制剂。对血凝素制剂用福尔马林处理，以破坏其诱导白细胞增多和引起组胺致敏的能力。向制剂中添加氢氧化铝作为佐剂。通过小鼠试验判断，该组分疫苗不仅效力高，而且通过白细胞增多促进、组胺致敏和内毒素测试判断，其毒性不到全细胞疫苗的十分之一。现场试验表明，组分疫苗与传统全细胞疫苗一样有效，且产生的副作用更少。自1981年秋季以来，该疫苗已在日本用于大规模免疫接种。
