Aluminum salts in vaccines - US perspective
Aluminum salts in vaccines - US perspective
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DOI：
10.1016/s0264-410x(02)00166-4
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发表时间：
2002-05-31
期刊：
影响因子：
5.5
通讯作者：
Richman, P
中科院分区：
文献类型：
--
作者：
Baylor, NW;Egan, W;Richman, P
氢氧化铝、磷酸铝或明矾形式的铝通常被用作美国食品和药物管理局(FDA)许可的许多疫苗的佐剂。美国联邦法规第21章[610.15(A)]将包括疫苗在内的生物制品中的铝含量限制在0.85毫克/剂。目前在美国获得许可的疫苗中的铝含量在0.8-0.125毫克/剂之间。临床研究表明，铝能增强白喉和破伤风类毒素等疫苗的抗原性。此外，铝吸附白喉和破伤风类毒素对儿童的初次免疫明显比普通液体类毒素有效。普通类毒素和吸附类毒素在加强免疫方面差异不大。铝佐剂的安全性已被证明超过60年；然而，这些佐剂与严重的局部反应有关，如红斑、皮下结节和接触性过敏。爱思唯尔科学有限公司出版。
Aluminum in the form of aluminum hydroxide, aluminum phosphate or alum has been commonly used as an adjuvant in many vaccines Licensed by the US Food and Drug Administration. Chapter 21 of the US Code of Federal Regulations [610.15(a)] limits the amount of aluminum in biological products, including vaccines, to 0.85 mg/dose. The amount of aluminum in vaccines currently licensed in the US ranges from 0.85-0.125 mg/dose. Clinical studies have demonstrated that aluminum enhances the antigenicity of some vaccines such as diphtheria and tetanus toxoids. Moreover, aluminium-adsorbed diphtheria and tetanus toxoids are distinctly more effective than plain fluid toxoids for primary immunization of children. There is little difference between plain and adsorbed toxoids for booster immunization. Aluminum adjuvants have a demonstrated safety profile of over six decades; however, these adjuvants have been associated with severe local reactions such as erythema, subcutaneous nodules and contact hypersensitivity. Published by Elsevier Science Ltd.