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.
CITAÇÃO DO ARTIGO Expert Rev Vaccines. 2009 Jan;8(1):43-50
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