de Cerio Ascensión López-Díaz, Inogés Susana
Laboratory of Immunotherapy, Division of Oncology, Center for Applied Medical Research, University of Navarra, Pamplona, Spain.
Expert Rev Vaccines. 2009 Jan;8(1):43-50. doi: 10.1586/14760584.8.1.43.
During the last three decades, idiotypic vaccination has cleared all the hurdles between preclinical studies and randomized clinical trials, assuming the forerunner role among human therapeutic cancer vaccines. However, over the last few months, the very same Phase III clinical trials that were supposed to consecrate idiotype vaccines as the first such products to reach the market have, one after another, begun failing to achieve their main end points. While their negative outcome had been predicted long ago, it must be underlined that most clinical studies on idiotypic vaccination have shown a substantial correlation between induction of an idiotype-specific immune response and improvement of clinical outcome. Failures of late-stage clinical trials were due to severe pitfalls in their study design and not necessarily to idiotypic vaccination itself. Therefore, it is desirable that dedicated scientists and clinicians persevere until confirming ultimately the clinical benefit of a broadly and readily available idiotype vaccine.
在过去三十年中，独特型疫苗跨越了临床前研究与随机临床试验之间的所有障碍，在人类治疗性癌症疫苗领域扮演了先驱角色。然而，在过去几个月里，本应使独特型疫苗成为首批上市此类产品的三期临床试验却相继未能达到其主要终点。尽管其负面结果早已被预测到，但必须强调的是，大多数关于独特型疫苗接种的临床研究表明，独特型特异性免疫反应的诱导与临床结果的改善之间存在显著相关性。晚期临床试验的失败是由于其研究设计存在严重缺陷，而不一定是独特型疫苗接种本身的问题。因此，希望专业的科学家和临床医生坚持不懈，直至最终确认一种广泛且易于获得的独特型疫苗的临床益处。
