Production, characterization and control of MenB-vaccine "Folkehelsa": an outer membrane vesicle vaccine against group B meningococcal disease.

NIPH annals Pub Date : 1991-12-01
J H Fredriksen, E Rosenqvist, E Wedege, K Bryn, G Bjune, L O Frøholm, A K Lindbak, B Møgster, E Namork, U Rye
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引用次数: 0

Abstract

A vaccine against serogroup B meningococcal disease has been prepared from a B:15:P1.7,16 meningococcal strain (44/76) by fermentor growth and extraction of the bacteria with the detergent deoxycholate. Outer membrane vesicles (OMV) were purified by ultracentrifugation and adsorbed to aluminium hydroxide adjuvant. OMV contained the major class 1, 3, 4 and 5 proteins and some minor high molecular weight protein components. Relative to protein, the vaccine also contained about 8% phospholipid, 7% lipopolysaccharide and 16% deoxycholate. The product was generally non-pyrogenic to humans in ordinary doses and was highly immunogenic in mice and humans. Production and control steps, physical, chemical and immunological data for the vaccine are described.

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“Folkehelsa”脑膜炎疫苗的生产、鉴定和控制:一种针对B群脑膜炎球菌病的外膜囊泡疫苗。
以B:15:P1.7,16脑膜炎球菌菌株(44/76)为原料,通过发酵罐培养和脱氧胆酸洗剂提取,制备了血清B群脑膜炎球菌病疫苗。采用超离心纯化外膜囊泡(OMV),并将其吸附在氢氧化铝佐剂上。OMV主要含有1、3、4、5类蛋白和少量高分子量蛋白组分。与蛋白质相比,该疫苗还含有约8%的磷脂、7%的脂多糖和16%的脱氧胆酸。该产品一般在普通剂量下对人体无热原性,在小鼠和人类中具有高度的免疫原性。介绍了疫苗的生产和控制步骤、物理、化学和免疫学数据。
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