Clinical trials with allergen products: in search of biological markers of efficacy.

摘要: I discuss herein our efforts to identify biological markers of efficacy in support the development sublingual allergy vaccines. Biomarkers are major interest facilitate clinical development, for example by predicting safety and candidate vaccines or their components (e.g. adjuvants formulations) on basis immunogenicity evaluated humans. They will be mandatory future evaluate customized recombinant designed upon component-resolved diagnosis. In this regard, they must ideally both qualitative quantitative. Such would also useful confirm foreseen mechanisms action potentially associated with successful immunotherapy Treg hypothesis). The recent availability sophisticated technologies (referred here as technology push) assess details humoral cellular arms immune system provides new opportunities such markers. documenting natural responses, most particularly allergen-specific T cell responses healthy persons, is critical immunological correlates protection, thus design optimal