The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved Human Peripheral Blood Mononuclear Cells

Journal of Immunological Methods

Volumn 409, Issue , 2014, Pages 21-30

  Sarzotti Kelsoe, Marcella ^a   Needham, Leila K ^a   Rountree, Wes ^a   Bainbridge, John ^a   Gray, Clive M ^b,f   Fiscus, Susan A ^c   Ferrari, Guido ^a   Stevens, Wendy S ^d,e   Stager, Susan L ^a   Binz, Whitney ^a   Louzao, Raul ^a   Long, Kristy O ^a   Mokgotho, Pauline ^b   Moodley, Niranjini ^b,e   Mackay, Melanie ^b,e   Kerkau, Melissa ^c   McMillion, Takesha ^c   Kirchherr, Jennifer ^a   Soderberg, Kelly A ^a   Haynes, Barton F ^a   Denny, Thomas N ^a   more..

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^e Clinical Laboratory Services   (South Africa)

^f UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

Biorepository; Cryopreservation; HIV; Human clinical trials; PBMC; Vaccine

Indexed keywords

AFRICA; ARTICLE; CELL VIABILITY; CONTROLLED STUDY; CRYOPRESERVATION; GOOD LABORATORY PRACTICE; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY CONTROL; THAWING; UNITED STATES;

BIOREPOSITORY; CRYOPRESERVATION; HIV; HUMAN CLINICAL TRIALS; PBMC; VACCINE;

AFRICA; AIDS VACCINES; CELL SURVIVAL; CLINICAL TRIALS AS TOPIC; CONSENSUS; COOPERATIVE BEHAVIOR; CRYOPRESERVATION; GUIDELINE ADHERENCE; HIV INFECTIONS; HUMANS; IMMUNOLOGIC TESTS; INTERNATIONAL COOPERATION; LABORATORIES; LABORATORY PROFICIENCY TESTING; LEUKOCYTES, MONONUCLEAR; LONGITUDINAL STUDIES; MONITORING, IMMUNOLOGIC; OBSERVER VARIATION; PRACTICE GUIDELINES AS TOPIC; PREDICTIVE VALUE OF TESTS; PROGRAM DEVELOPMENT; PROGRAM EVALUATION; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECIMEN HANDLING; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; WORKFLOW;

EID: 84906318244     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2014.05.013     Document Type: Article

References (25)

1. Afonso G., Scotto M., Renand A., Arvastsson J., Vassilieff D., Cilio C.M., Mallone R. Critical parameters in blood processing for T-cell assays: validation on ELISpot and tetramer platforms. J. Immunol. Methods 2010, 359:28.
2. Aziz N., Margolick J.B., Detels R., Rinaldo C.R., Phair J., Jamieson B.D., Butch A.W. Value of a quality assessment program in optimizing cryopreservation of peripheral blood mononuclear cells in a multicenter study. Clin. Vaccine Immunol. 2013, 20:590.
3. Bull M., Lee D., Stucky J., Chiu Y.L., Rubin A., Horton H., McElrath M.J. Defining blood processing parameters for optimal detection of cryopreserved antigen-specific responses for HIV vaccine trials. J. Immunol. Methods 2007, 322:57.
4. Cox J.H., Ferrari G., Kalams S.A., Lopaczynski W., Oden N., D'Souza M.P., E.C.S Group Results of an ELISPOT proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials. AIDS Res. Hum. Retrovir. 2005, 21:68.
5. Disis M.L., dela Rosa C., Goodell V., Kuan L.Y., Chang J.C.C., Kuus-Reichel K., Clay T.M., Lyerly H.K., Bhatia S., Ghanekar S.A., Maino V.C., Maecker H.T. Maximizing the retention of antigen specific lymphocyte function after cryopreservation. J. Immunol. Methods 2006, 308:13.
6. Ducar C., Smith D., Pinzon C., Stirewalt M., Cooper C., McElrath M.J., Hural J., the NIAID HIV Vaccine Trials Network Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal. J. Immunol. Methods 2014, 409:9.
7. Dyer W.B., Pett S.L., Sullivan J.S., Emery S., Cooper D.A., Kelleher A.D., Lloyd A., Lewin S.R. Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation quality assurance program using single donor samples. Clin. Vaccine Immunol. 2007, 14:52.
8. Ezzelle J., Rodriguez-Chavez I.R., Darden J.M., Stirewalt M., Kunwar N., Hitchcock R., Walter T., D'Souza M.P. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J. Pharm. Biomed. Anal. 2008, 46:18.
9. Garcia A., Keinonen S., Sanchez A.M., Ferrari G., Denny T.M., Moody M.A. Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs. J. Immunol. Methods 2014, 409:99. (in this issue).
10. Kierstead L.S., Dubey S., Meyer B., Tobery T.W., Mogg R., Fernandez V.R., Long R., Guan L., Gaunt C., Collins K., Sykes K.J., Mehrotra D.V., Chirmule N., Shiver J.W., Casimiro D.R. Enhanced rates and magnitude of immune responses detected against an HIV vaccine: effect of using an optimized process for isolating PBMC. AIDS Res. Hum. Retrovir. 2007, 23:86.
11. Kleeberger C.A., Lyles R.H., Margolick J.B., Rinaldo C.R., Phair J.P., Giorgi J.V. Viability and recovery of peripheral blood mononuclear cells cryopreserved for up to 12years in a multicenter study. Clin. Diagn. Lab. Immunol. 1999, 6:14.
12. Kreher C.R., Dittrich M.T., Guerkov R., Boehm B.O., Tary-Lehmann M. CD4+ and CD8+ cells in cryopreserved human PBMC maintain full functionality in cytokine ELISPOT assays. J. Immunol. Methods 2003, 278:79.
13. Olemukan R.E., Eller L.A., Ouma B.J., Etonu B., Erima S., Naluyima P., Kyabaggu D., Cox J.H., Sandberg J.K., Wabwire-Mangen F., Michael N.L., Robb M.L., de Souza M.S., Eller M.A. Quality monitoring of HIV-1-infected and uninfected peripheral blood mononuclear cell samples in a resource-limited setting. Clin. Vaccine Immunol. 2010, 17:910.
14. Ramachandran H., Laux J., Moldovan I., Caspell R., Lehmann P.V., Subramanian R.A. Optimal thawing of cryopreserved peripheral blood mononuclear cells for use in high-throughput human immune monitoring studies. Cells 2012, 1:313.
15. Reimann K.A., Chernoff M., Wilkening C.L., Nickerson C.E., Landay A.L., ACTG Immunology Advanced Technology Laboratories Preservation of lymphocyte immunophenotype and proliferative responses in cryopreserved peripheral blood mononuclear cells from human immunodeficiency virus type 1-infected donors: implications for multicenter clinical trials. Clin. Diagn. Lab. Immunol. 2000, 7:352.
16. Riou C., Ganusov V.V., Campion S., Mlotshwa M., Liu M.K., Whale V.E., Goonetilleke N., Borrow P., Ferrari G., Betts M.R., Haynes B.F., McMichael A.J., Gray C.M. Distinct kinetics of Gag-specific CD4+ and CD8+ T cell responses during acute HIV-1 infection. J Immunol. 2012 Mar 1, 188(5):2198-2206. Epub 2012 Jan 27. 10.4049/jimmunol.1102813.
17. Sarzotti-Kelsoe M., Cox J., Cleland N., Denny T., Hural J., Needham L., Ozaki D., Rodriguez-Chavez I.R., Stevens G., Stiles T., Tarragona-Fiol T., Simkins A. Evaluation and recommendations on Good Clinical Laboratory Practice (GCLP) guidelines for phase I-III clinical trials. PLoS Med. 2009, 6(5):e1000067. 10.1371/journal.pmed.1000067.
18. Sleasman J.W., Leon B.H., Aleixo L.F., Rojas M., Goodenow M.M. Immunomagnetic selection of purified monocyte and lymphocyte populations from peripheral blood mononuclear cells following cryopreservation. Clin. Diagn. Lab. Immunol. 1997, 4:653.
19. Smith J.G., Liu X., Kaufhold R.M., Clair J., Caulfield M.J. Development and validation of a gamma interferon ELISPOT assay for quantitation of cellular immune responses to varicella-zoster virus. Clin. Diagn. Lab. Immunol. 2001, 8:871.
20. Smith J.G., Joseph H.R., Green T., Field J.A., Wooters M., Kaufhold R.M., Antonello J., Caulfield M.J. Establishing acceptance criteria for cell-mediated-immunity assays using frozen peripheral blood mononuclear cells stored under optimal and suboptimal conditions. Clin. Vaccine Immunol. 2007, 14:527.
21. Stiles T., Grant V., Mawbey N. Good clinical laboratory practice. A Quality System for Laboratories which undertake the Analyses of Samples from Clinical Trials 2003, 1. British Association of Research Quality Assurance, Ipswich, United Kingdom.
22. Weinberg A., Zhang L., Brown D., Erice A., Polsky B., Hirsch M.S., Owens S., Lamb K. Viability and functional activity of cryopreserved mononuclear cells. Clin. Diagn. Lab. Immunol. 2000, 7:714.
23. Weinberg A., Louzao R., Mussi-Pinhata M.M., Cruz M.L., Pinto J.A., Huff M.F., de Castro A.C., Sucupira M.C., Denny T.N. Quality assurance program for peripheral blood mononuclear cell cryopreservation. Clin. Vaccine Immunol. 2007, 14:1242.
24. Weinberg A., Song L.Y., Wilkening C., Sevin A., Blais B., Louzao R., Stein D., Defechereux P., Durand D., Riedel E., Raftery N., Jesser R., Brown B., Keller M.F., Dickover R., McFarland E., Fenton T., Pediatric ACTG Cryopreservation Working Group Optimization and limitations of use of cryopreserved peripheral blood mononuclear cells for functional and phenotypic T-cell characterization. Clin. Vaccine Immunol. 2009, 16:1176.
25. Weinberg A., Song L.Y., Wilkening C.L., Fenton T., Hural J., Louzao R., Ferrari G., Etter P.E., Berrong M., Canniff J.D., Carter D., De Fawe O.D., Garcia A., Garrelts T.L., Gelman R., Lambrecht L.K., Pahwa S., Pilakka-Kanthikeel S., Shugarts D.L., Tustin N.B. Optimization of storage and shipment of cryopreserved peripheral blood mononuclear cells from HIV-infected and uninfected individuals for ELISPOT assays. J. Immunol. Methods 2010, 363:42.