Immunology Quality Assurance Center Awarded $4.5 Million


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January 18, 2008

The Human Vaccine Institute at Duke University Medical Center was awarded $4.5 million from the National Institutes of Health last month to establish the Peripheral Blood Mononuclear Cell (PBMC) Quality Assurance Program.  This new program will offer proficiency testing of PBMC cryopreservation at sites funded by the National Institute of Allergy and Infectious Disease (NIAID).  Use of PBMC’s for HIV research has dramatically increased in recent years as vaccine discovery efforts and multi-center clinical trial networks have expanded. 

Peripheral Blood Mononuclear Cells (PBMC’s) such as CD4+ cells are invaluable for HIV research.  The levels of CD4+ cells, a primary target of HIV infection, can indicate how the immune system is responding to infection over a specific period of time.  Cryopreserved PBMC’s are particularly handy because they can be used after the conclusion of a clinical trial if questions arise due to new developments in the field.  They also allow for testing in a single laboratory, which eliminates any inter-laboratory variability that can occur with multi-site studies.  Additionally, researchers can conduct batch testing with cryopreserved PBMC’s where multiple time points from an individual study participant are all tested at the same time, which in turn reduces inter-assay variability. 
The Immunology Quality Assurance Center (IQAC) launched at the Duke Human Vaccine Institute in early 2007 will lead the PBMC Quality Assurance project.  The IQAC, headed by Thomas Denny, currently supports the Center for HIV/AIDS Vaccine Immunology (CHAVI) and the Gates Collaborative AIDS Vaccine Discovery Initiative (CAVD) investigator-initiated projects by offering flow cytometry, functional immunology, core virology, assay development and cryopreservation / repository services.
For this new PBMC QA program, the IQAC team will develop sensitive functional and phenotypic assays to monitor the quality of frozen PBMC’s including cell recovery, cell viability, and biological function.  They will carefully evaluate the existing cell yield, cell viability, and time from processing to cryopreservation at laboratories managing clinical specimens.  The team will also provide Quality Control (QC) mechanisms to assess the ability of sites to process, freeze, store and ship viable PBMC’s for future use.  As part of this initiative, the IQAC will establish a Data Management Center and will provide statistical analysis of the QC results.  Finally, with the help of this grant the IQAC will establish and maintain a PBMC cell bank harvested from donors participating in the ongoing CHAVI leukapheresis program. 
The PBMC QA grant follows a $7.6 million grant awarded by the NIAID to the IQAC team in October 2007 to improve CD4 rapid testing at NIAID funded clinical sites.  For more information on this award, please read the press release, “Duke’s Human Vaccine Institute Awarded $7.6 Million.”