辅助剂临床评价的欧盟法规指南

B. Klug, P. Celis, Robin Ruepp, J. Robertson
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引用次数: 2

摘要

佐剂已被纳入疫苗几十年,以提高免疫应答疫苗抗原。在开发新疫苗或仅仅改进现有疫苗的过程中,对佐剂的兴趣迅速增长,有各种类型的佐剂(一些是新型的;有些已被纳入临床研究或正在开发的特定疫苗中。佐剂的开发通常与特定疫苗的开发密切相关。由于佐剂是最终药品的组成部分,目前的立法没有预见到将佐剂作为独立产品授予授权。专门的欧盟指南涉及疫苗佐剂的非临床和临床开发的质量,该指南需要与一般药品的具体指南一起考虑。本文概述了开发或修改佐剂疫苗的要求。作者还讨论了2009年H1N1大流行性流感佐剂疫苗获得的经验及其影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
EU regulatory guidelines for the clinical evaluation of adjuvants
Abstract Adjuvants have been incorporated into vaccines for decades to improve the immune response to vaccine antigens. In developing new vaccines or simply improving existing vaccines, interest in adjuvants has been growing rapidly, with various types of adjuvant (some novel; some already incorporated into specific vaccines) used in clinical research or under development. The development of adjuvants is generally closely linked to the development of a specific vaccine. With the adjuvant being an integral constituent of the final medicinal product, current legislation does not foresee authorization being granted for an adjuvant as a stand-alone product. A dedicated EU guideline addresses the quality non-clinical and clinical development of vaccine adjuvants, and this guidance needs to be considered alongside the specific guidelines for medicinal products in general. This paper provides an overview of the requirements for developing or modifying an adjuvanted vaccine. The authors also address the experience gained for the adjuvanted 2009 H1N1 pandemic influenza vaccine and its implications.
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