About the ImmunoAssay Proficiency Panel Program

Monitoring the antigen-specific immune response has become an important end point in the clinical evaluation of specific cancer immunotherapeutics. The early identification of such responses allows prioritizing vaccines for further clinical evaluation.

Furthermore, study of the immune response to cancer vaccination may lead to the identification of surrogate markers of effective anti-cancer immunization, which could provide enough prognostic data to meet regulatory standards of clinical effectiveness of new therapies, potentially shortening the time for demonstrating a new therapy's clinical benefit.

The Cancer Immunotherapy Consortium (formerly the Cancer Vaccine Consortium) has established an ImmunoAssay Working Group to help facilitate and harmonize the immune monitoring approaches in the larger cancer vaccine community. The program’s objectives are: 1) to offer an external validation program, and 2) to enhance assay harmonization.

The Proficiency Panel Program seeks to:

• Identify:
  • issues and deficiencies of current assay practices;
  • sources for assay variability within and among institutions;
  • protocol details that optimize assay performance.
• Define criteria for and support harmonization & validation of the assay for individual member laboratories.
• Determine the value of resulting criteria in the cancer immunotherapy community.
• Offer training programs to the cancer immunotherapy community to enhance assay performance and comparability between laboratories.
• Establish immune assays as standard monitoring tools, if feasible.

Each assay panel is under specific scientific supervision as follows:

• ELISPOT -- Dr. Sylvia Janetzki, ZellNet Consulting
• ICS -- Dr. Lisa McNeil, Wyeth
• Multimer (Tetramer/Pentamer) Staining -- Dr. Pedro Romero, Ludwig Institute for Cancer Research, Lausanne, Switzerland, and Dr. Cedrik Britten, University of Leiden, The Netherlands

Central laboratory services, cells, and shipping are provided by the Immunology Quality Assurance Center (IQAC) of the Duke Human Vaccine Institute (Durham, NC) under the leadership of Dr. Thomas Denny."

Data management is organized via our centralized web site: http://cvc.assaymgmt.webbasix.com/

Statistical analysis is being provided by Leah Ben-Porath.

If you are interested in participation in any of these panels or any combination of those, please contact Assay Working Group coordinator Sylvia Janetzki: sylvia@zellnet.com, (201) 346-0710.

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Panel participants: Click here to access the data management website.

View the Cancer Immunotherapy Consortium Protocol Recommendations 

You can also access publications produced by the ImmunoAssay Working Group:

"Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI)" Cancer Immunology Immunotherapy.

"Toward the harmonization of immune monitoring in clinical trials: Quo vadis?" Cancer Immunology Immunotherapy.

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