Kurzfassung

The interpretation of the results obtained from immunomonitoring of clinical trials is a difficult task due to the variety of methods and protocols available to detect vaccine-specific T-cell responses. The enzyme-linked immunospot (ELISPOT) assay, staining with HLA-peptide multimers and intracellular cytokine staining (ICS) are technologies commonly used for the monitoring of antigen-specific immune responses. For these three assays, a huge variety of different protocols are available...The interpretation of the results obtained from immunomonitoring of clinical trials is a difficult task due to the variety of methods and protocols available to detect vaccine-specific T-cell responses. The enzyme-linked immunospot (ELISPOT) assay, staining with HLA-peptide multimers and intracellular cytokine staining (ICS) are technologies commonly used for the monitoring of antigen-specific immune responses. For these three assays, a huge variety of different protocols are available worldwide. This heterogeneity, together with the lack of standards and the fact that the sensitivity of the individual protocols can vary significantly, makes a comparison of the results obtained in different trials a difficult task and has led to significant scepticism towards published results. Moreover, an increasing number of new technologies are constantly being introduced to the field, which makes interpretations even more complex. It is clear that there is an urgent need to ensure that the results generated by the tests are reproducible and sensitive, independently of the place where they have been performed. Previously, a working group was founded under the aegis of the Association for Immunotherapy of Cancer (“CIMT”) in order to compare techniques and protocols applied for the enumeration of antigen-specific T-cell responses. After the first series of inter-laboratory testing projects, in which individual laboratories could compare their performance, express their needs and exchange experience in order to improve their local assays, at least, 3 bottle necks were identified:

1. Co-ordination of efforts between scientists from different fields or different countries and establishment of centers of excellence that can provide services and education to a broad group of users over many years.

2. Cell samples that contain pre-defined numbers of antigen-specific T-cells are not available but are urgently needed.

In this project proposal we present 2 work packages (WP) which focus on resolving these bottle necks.
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