Measuring Human Immunity
Reported trials of cancer immunotherapy, including vaccines, are demonstrating the ability to elicit detectable tumor specific immunity in cancer patients. There are no standard immunologic monitoring methods that will allow comparison of immune based clinical strategies between labs or will even allow accurate assessment of the immunogenicity of a particular approach. Standardization and development of reproducible and clinical grade immunologic assays to determine the magnitude of tumor specific immune responses generated in the context of clinical trials of cancer immunotherapy is an area of research in the CVI.
A goal of the CVI is to develop immunologic correlates of cancer vaccine efficacy. The precedent for the identification of well accepted surrogates to vaccine efficacy has been set in infectious disease models where many vaccines are associated with laboratory measures which correlate to protection from disease. In addition, novel highly quantitative methods for the enumeration of T cells and the assessment of their function are being developed.
The CVI houses an Immunologic Monitoring Laboratory (IML) that executes both clinically validated assays as well as research on novel methods of measuring immunity. The IML allows for clinical development of laboratory based assays such as ELISPOT, flow cytometry for intracellular cytokine staining, MHC tetramers, and class and isotype quantitative antibody assays. It is essential to determine the accuracy, precision, sensitivity, specificity, and reliability of these technologies. Whereas assay validation is straightforward, in many respects, for serologic studies, validations of T cell based techniques require the expertise of both molecular and cellular immunologists at the CVI in generating standards for analysis and novel design of validation approaches. The IML also allows for clinical development and troubleshooting of techniques in well defined antigen systems and demonstration of applied principles to cancer antigen models.
How CVI Measures Immunity
We have developed clinical grade assays for both tumor specific T cell and antibody evaluation and have collaborated with investigators around the world to analyze samples collected on a variety of clinical trials.
We have defined the accuracy and precision of the most common T cell assays and demonstrated how those measurements correlate with each other.
Our core laboratory serves as a training resource for those scientists who would like to develop similar clinical immunologic monitoring cores.