Cancer immunotherapy is based on the premise that the patient's own immune system can be activated to eliminate preexisting cancer. Investigating immunological parameters during cancer vaccine therapy is referred to as immune monitoring. Monitoring cellular immune responses is essential for rational cancer vaccine development. The primary objectives of immune monitoring after vaccination are (a) to document the induction of vaccine-specific and tumor-specific immune responses and (b) to correlate the presence and magnitude of vaccine-induced immune responses to clinical outcome. Despite advances in the development of immune monitoring assays during the past decade, it has been difficult to establish significant correlations between the vaccine-induced immune responses and clinical outcome. Therefore, there is a general consensus that further studies are required to investigate reasons for this lack of correlations between different aspects of T-cell function and clinical efficacy. Vaccine-induced immune responses against cancer are likely a balance between immune responses of various subsets of both effector and suppressor T cells.

The main focus of this special issue will be on the strengths, weaknesses, and applications of current cellular immune monitoring assays in recent cancer vaccine clinical trials. We are particularly interested in manuscripts that report on cellular immune monitoring assays in cancer vaccine trials with vaccines showing evidence of clinical benefit; efficacy implies a more definitive level of evidence, essentially what the FDA requires for approval or novel immune assays applied in clinical trials of all stages. Potential topics include, but are not limited to:

• Quality control, quality assurance, standardization, validation of cellular immune monitoring methods, and minimal information about T cell assays
• Comparisons of immune monitoring methods to help in selection of optimal assays
• Innate immune responses (NK cells, sMICA, NKG2D)
• Novel cellular immune monitoring assays
• Evaluation of the potency of cancer vaccine therapies: including regulators of immune response (regulatory T cells, myeloid suppressor cells, NK T cells, and others)
• Assessment of the correlation between cellular immune responses and clinical responses
• Comparison of antibody responses with cellular immune responses
• Genomic applications for monitoring of cellular immune responses
• Statistical analyses of serial immunologic measurements

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