Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers

Clinical Cancer Research

Volumn 17, Issue 10, 2011, Pages 3064-3076

  Butterfield, Lisa H ^a   Palucka, A Karolina ^c,d   Britten, Cedrik M ^t,u   Dhodapkar, Madhav V ^e   Håkansson, Leif ^y   Janetzki, Sylvia ^f   Kawakami, Yutaka ^z   Kleen, Thomas Oliver ^h   Lee, Peter P ⁱ   Maccalli, Cristina ^ab   Maecker, Holden T ⁱ   Maino, Vernon C ^j   Maio, Michele ^ad   Malyguine, Anatoli ^k   Masucci, Giuseppe ^x   Pawelec, Graham ^v   Potter, Douglas M ^b   Rivoltini, Licia ^ac   Salazar, Lupe G ^p   Schendel, Dolores J ^w   Slingluff Jr , Craig L ^q   Song, Wenru ^r   Stroncek, David F ^m   Tahara, Hideaki ^aa   Thurin, Magdalena ^o   Trinchieri, Giorgio ^l   Van Der Burg, Sjoerd H ^ae   Whiteside, Theresa L ^a   Wigginton, Jon M ^g   Marincola, Francesco ⁿ   Khleif, Samir ^o   Fox, Bernard A ^s   Disis, Mary L ^p,af   more..

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^c BAYLOR INSTITUTE FOR IMMUNOLOGY RESEARCH   (United States)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e YALE UNIVERSITY   (United States)

^f ZellNet Consulting Inc   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

^h Cellular Technology Limited   (United States)

ⁱ STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j BD BIOSCIENCES   (United States)

^k SAIC FREDERICK INC   (United States)

^l NATIONAL CANCER INSTITUTE   (United States)

^m CLINICAL CENTER   (United States)

ⁿ NIH ^*  (United States)

^o NATIONAL INSTITUTES OF HEALTH   (United States)

^p UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^q UNIVERSITY OF VIRGINIA   (United States)

^r PFIZER INC   (United States)

^s PROVIDENCE PORTLAND MEDICAL CENTER   (United States)

^t JOHANNES GUTENBERG UNIVERSITY   (Germany)

^u BIONTECH AG   (Germany)

^v UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^w TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^x KAROLINSKA INSTITUTE   (Sweden)

^y CamImGuide Therapeutics AB   (Sweden)

^z KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^aa UNIVERSITY OF TOKYO   (Japan)

^ab SAN RAFFAELE HOSPITAL   (Italy)

^ac NATIONAL CANCER INSTITUTE   (Italy)

^ad CENTRO DI RIFERIMENTO ONCOLOGICO   (Italy)

^ae LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^af UNIVERSITY OF WASHINGTON   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; BLOOD DERIVATIVE; CYTOKINE; DENDRITIC CELL VACCINE; DNA VACCINE; E 1696; GAMMA INTERFERON; HLA A2 ANTIGEN; INTERCELLULAR ADHESION MOLECULE 1; INTERLEUKIN 12P70; INTERLEUKIN 2; PEPTIDE VACCINE; TUMOR NECROSIS FACTOR; UNCLASSIFIED DRUG; VACCINIA VACCINE;

ANTIGEN SPECIFICITY; BIOLOGICAL THERAPY; BLOOD ANALYSIS; BLOOD STORAGE; CANCER IMMUNOTHERAPY; CRYOPRESERVATION; DIAGNOSTIC ACCURACY; ENZYME LINKED IMMUNOSPOT ASSAY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOLOGICAL MONITORING; IMMUNOLOGICAL PROCEDURES; LABORATORY TEST; MALIGNANT NEOPLASTIC DISEASE; MELANOMA; NATIONAL HEALTH ORGANIZATION; PERIPHERAL BLOOD MONONUCLEAR CELL; PHENOTYPE; PRIORITY JOURNAL; PROSTATE CARCINOMA; QUALITY CONTROL; REGULATORY T LYMPHOCYTE; REPRODUCIBILITY; REVIEW; TUMOR IMMUNITY; WORKSHOP;

CONSENSUS DEVELOPMENT CONFERENCES AS TOPIC; HEALTH PLANNING GUIDELINES; HUMANS; IMMUNOTHERAPY; INTERNATIONAL AGENCIES; MEDICAL ONCOLOGY; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; PRACTICE GUIDELINES AS TOPIC; SOCIETIES, MEDICAL; TUMOR MARKERS, BIOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79956000143     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-2234     Document Type: Review

References (94)

1. Dendreon. www.dendreon.com. Available from: http://investor.dendreon. com/phoenix.zhtml?c=120739&p=irol-newsArticle&ID=1398598&highlight=.
2. Kantoff PW HC, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, et al. Sepuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-81.
3. Available from: http://www.asco.org/ASCOv2/Meetings/Abstracts? &vmview=abst-detail-view&confID=65&abstractID=32035.
4. Schwartzentruber DJ, Lawson D, Richards J, Conry RM, Miller D, Triesman J, et al. A phase III multi-institutional randomized study of immunization with the gp100;209-217 (210M) peptide followed by high-dose IL-2 compared with high-dose IL-2 alone in patients with metastatic melanoma. J Clin Oncol 2009;27:18s.
5. Schuster SJ, Neelapu SS, Gause BL, Muggia FM, Gockerman JP, Sotomayor EM, et al. Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: phase III clinical trial results. ASCO Meeting Abstract. J Clin Oncol 2009;27:2.
6. Morgan RA, Dudley ME, Wunderlich JR, Hughes MS, Yang JC, Sherry RM, et al. Cancer regression in patients after transfer of genetically engineered lymphocytes. Science 2006;314:126-9. (Pubitemid 44547756)
7. Rosenberg SA, Restifo NP, Yang JC, Morgan RA, Dudley ME. Adoptive cell transfer: a clinical path to effective cancer immunotherapy. Nat Rev Cancer 2008;8:299-308. (Pubitemid 351430867)
8. Lee KH, Wang E, Nielsen MB, Wunderlich J, Migueles S, Connors M, et al. Increased vaccine-specific T cell frequency after peptide-based vaccination correlates with increased susceptibility to in vitro stimulation but does not lead to tumor regression. J Immunol 1999;163:6292-300.
9. Butterfield LH, Comin-Anduix B, Vujanovic L, Lee Y, Dissette VB, Yang JQ, et al. Adenovirus MART-1-engineered autologous dendritic cell vaccine for metastatic melanoma. J Immunother 2008;31:294-309. (Pubitemid 351441001)
10. Butterfield LH, Ribas A, Dissette VB, Amarnani SN, Vu HT, Oseguera D, et al. Determinant spreading associated with clinical response in dendritic cell-based immunotherapy for malignant melanoma. Clin Cancer Res 2003;9:998-1008. (Pubitemid 36323703)
11. Ribas A, Glaspy JA, Lee Y, Dissette VB, Seja E, Vu HT, et al. Role of dendritic cell phenotype, determinant spreading, and negative costimulatory blockade in dendritic cell-based melanoma immunotherapy. J Immunother 2004;27:354-67. (Pubitemid 39121924)
12. Keilholz U, Weber J, Finke JH, Gabrilovich DI, Kast WM, Disis ML, et al. Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy. J Immunother 2002;25:97-138. (Pubitemid 34260764)
13. Available from: http://www.cancer.gov/images/trwg/immune-oct08.pdf.
14. Available from: http://www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/ucm079855.pdf.
15. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/ CriticalPathInitiative/default.htm.
16. Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewycz AH, Koehler M, et al. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res 2010;16:1745-55.
17. Bull M, Lee D, Stucky J, Chiu YL, Rubin A, Horton H, et al. Defining blood processing parameters for optimal detection of cryopreserved antigen-specific responses for HIV vaccine trials. J Immunol Methods 2007;322:57-69. (Pubitemid 46560582)
18. Kierstead LS, Dubey S, Meyer B, Tobery TW, Mogg R, Fernandez VR, et al. Enhanced rates and magnitude of immune responses detected against an HIV vaccine: effect of using an optimized process for isolating PBMC. AIDS Res Hum Retroviruses 2007;23:86-92. (Pubitemid 46214176)
19. Ruitenberg JJ, Mulder CB, Maino VC, Landay AL, Ghanekar SA. VACUTAINER CPT and Ficoll density gradient separation perform equivalently in maintaining the quality and function of PBMC from HIV seropositive blood samples. BMC Immunol 2006;7:11.
20. Available from: http://www.irb.pitt.edu/irbmailings/listbot6-20-05.htm.
21. Disis ML, Dang Y, Slota MS, Childs J, Higgins D, Bates N, et al., and Members of the Immunologic Monitoring Consortium. [cited 2009] Available from: http://www.isbtc.org/meetings/access.php?content=workshop09pres&loc=/ meetings/am09/workshop09/presentations/ Disis-915am.pdf.
22. Nicolette CA, Healey D, Tcherepanova I, Whelton P, Monesmith T, Coombs L, et al. Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products. Vaccine 2007;25 Suppl 2:B47-60.
23. Sheikh NA, Jones LA. CD54 is a surrogate marker of antigen presenting cell activation. Cancer Immunol Immunother 2008;57:1381-90.
24. Mailliard RB, Wankowicz-Kalinska A, Cai Q, Wesa A, Hilkens CM, Kapsenberg ML, et al. alpha-type-1 polarized dendritic cells: a novel immunization tool with optimized CTL-inducing activity. Cancer Res 2004;64:5934-7. (Pubitemid 39129387)
25. Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009;115: 3670-9.
26. Butterfield LH, Gooding W, Whiteside TL. Development of a potency assay for human dendritic cells: IL-12p70 production. J Immunother 2008;31:89-100. (Pubitemid 351619408)
27. Draft guidance for industry-potency tests for cellular and gene therapy products. [cited 2008]. Available from: http://www.fda.gov/cber/gdlns/ testcellgene.htm.
28. Dang Y, Disis ML. Identification of immunologic biomarkers associated with clinical response after immune-based therapy for cancer. Ann N Y Acad Sci 2009;1174:81-7.
29. Available from: http://www.cms.hhs.gov/CLIA/05-CLIA-Brochures.asp.
30. ICH. Available from: http://www.ich.org/LOB/media/MEDIA417.pdf.
31. NCCLS. Performance of Single Cell Immune Response Assays: Proposed Guidelines. NCCLS document I/LA26-P [ISBN 1-56238-507-0]. Vol. 23, Number 25. Wayne, PA: NCCLS.; 2003.
32. Zhang W, Caspell R, Karulin AY, Ahmad M, Haicheur N, Abdelsalam A, et al. ELISPOT assays provide reproducible results among different laboratories for T-cell immune monitoring-even in hands of ELISPOT-inexperienced investigators. J Immunotoxicol 2009;6:227-34.
33. Janetzki S, Panageas KS, Ben-Porat L, Boyer J, Britten CM, Clay TM, et al. Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol Immunother 2008;57:303-15. (Pubitemid 350295382)
34. Maecker HT, Hassler J, Payne JK, Summers A, Comatas K, Ghanayem M, et al. Precision and linearity targets for validation of an IFNgamma ELISPOT, cytokine flow cytometry, and tetramer assay using CMV peptides. BMC Immunol 2008;9:9.
35. Britten CM, Gouttefangeas C, Welters MJ, Pawelec G, Koch S, Ottensmeier C, et al. The CIMT-monitoring panel: a two-step approach to harmonize the enumeration of antigen-specific CD8+ T lymphocytes by structural and functional assays. Cancer Immunol Immunother 2008;57:289-302. (Pubitemid 350295380)
36. Britten CM, Janetzki S, Ben-Porat L, Clay TM, Kalos M, Maecker H, et al. Harmonization guidelines for HLA-peptide multimer assays derived from results of a large scale international proficiency panel of the Cancer Vaccine Consortium. Cancer Immunol Immunother 2009;58:1701-13.
37. Britten CM, Janetzki S, Van Der Burg SH, Gouttefangeas C, Hoos A. Toward the harmonization of immune monitoring in clinical trials: quo vadis? Cancer Immunol Immunother 2008;57:285-8.
38. Mander A, Gouttefangeas C, Ottensmeier C, Welters MJ, Low L, van der Burg SH, et al. Serum is not required for ex vivo IFN-gamma ELISPOT: a collaborative study of different protocols from the European CIMT Immunoguiding Program. Cancer Immunol Immunother 2010;59:619-27.
39. Fahey JL, Aziz N, Spritzler J, Plaeger S, Nishanian P, Lathey JL, et al. Need for an external proficiency testing program for cytokines, chemokines, and plasma markers of immune activation. Clin Diagn Lab Immunol 2000;7:540-8. (Pubitemid 30463209)
40. Denny TN, Gelman R, Bergeron M, Landay A, Lam L, Louzao R, et al. A North American multilaboratory study of CD4 counts using flow cytometric panLeukogating (PLG): a NIAID-DAIDS Immunology Quality Assessment Program Study. Cytometry B Clin Cytom 2008; 74 Suppl 1:S52-64.
41. Boaz MJ, Hayes P, Tarragona T, Seamons L, Cooper A, Birungi J, et al. Concordant proficiency in measurement of T-cell immunity in human immunodeficiency virus vaccine clinical trials by peripheral blood mononuclear cell and enzyme-linked immunospot assays in laboratories from three continents. Clin Vaccine Immunol 2009; 16:147-55.
42. Smith SG, Joosten SA, Verscheure V, Pathan AA, McShane H, Ottenhoff TH, et al. Identification of major factors influencing ELI-Spot- based monitoring of cellular responses to antigens from Mycobacterium tuberculosis. PLoS One 2009;4:e7972.
43. Hanekom WA, Dockrell HM, Ottenhoff TH, Doherty TM, Fletcher H, McShane H, et al. Immunological outcomes of new tuberculosis vaccine trials:WHOpanel recommendations. PLoS Med 2008;5:e145.
44. Avache S, Panelli M, Marincola FM, Stroncek DF. Effects of storage time and exogenous protease inhibitors on plasma protein levels. Am J Clin Pathol 2006;126:174-84. (Pubitemid 44162561)
45. Kirkwood JM, Lee S, Moschos SJ, Albertini MR, Michalak JC, Sander C, et al. Immunogenicity and antitumor effects of vaccination with peptide vaccine+/-granulocyte-monocyte colony-stimulating factor and/or IFN-alpha2b in advanced metastatic melanoma: Eastern Cooperative Oncology Group Phase II Trial E1696. Clin Cancer Res 2009;15:1443-51.
46. Slingluff CL Jr, Petroni GR, Chianese-Bullock KA, Smolkin ME, Hibbitts S, Murphy C, et al. Immunologic and clinical outcomes of a randomized phase II trial of two multipeptide vaccines for melanoma in the adjuvant setting. Clin Cancer Res 2007;13:6386-95. (Pubitemid 350075028)
47. Dangoor A, Lorigan P, Keilholz U, Schadendorf D, Harris A, Ottensmeier C, et al. Clinical and immunological responses in metastatic melanoma patients vaccinated with a high-dose poly-epitope vaccine. Cancer Immunol Immunother 2010;59:863-73.
48. Welters MJ, Kenter GG, Piersma SJ, Vloon AP, Löwik MJ, Berendsvan der Meer DM, et al. Induction of tumor-specific CD4+ and CD8+ T-cell immunity in cervical cancer patients by a human papillomavirus type 16 E6 and E7 long peptides vaccine. Clin Cancer Res 2008;14:178-87. (Pubitemid 351377994)
49. Kenter GG, Welters MJ, Valentijn AR, Lowik MJ, Berends-van der Meer DM, Vloon AP, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med 2009;361:1838-47.
50. Welters MJ, Kenter GG, de Vos van Steenwijk PJ, Löwik MJ, Berendsvan der Meer DM, Essahsah F, et al. Success or failure of vaccination for HPV16-positive vulvar lesions correlates with kinetics and phenotype of induced T-cell responses. Proc Natl Acad Sci U S A 2010;107:11895-9.
51. Quast S, Zhang W, Shive C, Kovalovski D, Ott PA, Herzog BA, et al. IL- 2 absorption affects IFN-gamma and IL-5, but not IL-4 producing memory T cells in double color cytokine ELISPOT assays. Cell Immunol 2005;237:28-36. (Pubitemid 41821079)
52. Rininsland FH, Helms T, Asaad RJ, Boehm BO, Tary-Lehmann M. Granzyme B ELISPOT assay for ex vivo measurements of T cell immunity. J Immunol Methods 2000;240:143-55. (Pubitemid 30347410)
53. Shafer-Weaver K, Rosenberg S, Strobl S, Gregory Alvord W, Baseler M, Malyguine A. Application of the granzyme B ELISPOT assay for monitoring cancer vaccine trials. J Immunother 2006;29:328-35. (Pubitemid 44297301)
54. Dhodapkar MV, Steinman RM, Sapp M, Desai H, Fossella C, Krasovsky J, et al. Rapid generation of broad T-cell immunity in humans after a single injection of mature dendritic cells. J Clin Invest 1999;104:173-80.
55. Iero M, Filipazzi P, Castelli C, Belli F, Valdagni R, Parmiani G, et al. Modified peptides in anti-cancer vaccines: are we eventually improving anti-tumour immunity? Cancer Immunol Immunother 2009;58: 1159-67.
56. Malyguine A, Strobl SL, Shafer-Weaver KA, Ulderich T, Troke A, Baseler M, et al. A modified human ELISPOT assay to detect specific responses to primary tumor cell targets. J Transl Med 2004;2:9.
57. Kim GG, Donnenberg VS, Donnenberg AD, Gooding W, Whiteside TL. A novel multiparametric flow cytometry-based cytotoxicity assay simultaneously immunophenotypes effector cells: comparisons to a 4 h 51Cr-release assay. J Immunol Methods 2007;325:51-66. (Pubitemid 47238289)
58. Devevre E, Romero P, Mahnke YD. LiveCount Assay: concomitant measurement of cytolytic activity and phenotypic characterisation of CD8(+) T-cells by flow cytometry. J Immunol Methods 2006;311: 31-46.
59. Zaritskaya L, Shafer-Weaver KA, Gregory MK, Strobl SL, Baseler M, Malyguine A. Application of a flow cytometric cytotoxicity assay for monitoring cancer vaccine trials. J Immunother 2009;32:186-94.
60. Maecker HT, Dunn HS, Suni MA, Khatamzas E, Pitcher CJ, Bunde T, et al. Use of overlapping peptide mixtures as antigens for cytokine flow cytometry. J Immunol Methods 2001;255:27-40.
61. Nomura L, Maino VC, Maecker HT. Standardization and optimization of multiparameter intracellular cytokine staining. Cytometry A 2008;73:984-91.
62. Dols A, Smith JW II, Meijer SL, Fox BA, Hu HM, Walker E, et al. Vaccination of women with metastatic breast cancer, using a costimulatory gene (CD80)-modified, HLA-A2-matched, allogeneic, breast cancer cell line: clinical and immunological results. Hum Gene Ther 2003;14:1117-23. (Pubitemid 36851402)
63. Walker EB, Haley D, Petrausch U, Floyd K, Miller W, Sanjuan N, et al. Phenotype and functional characterization of long-term gp100-specific memory CD8+ T cells in disease-free melanoma patients before and after boosting immunization. Clin Cancer Res 2008;14:5270-83.
64. Slingluff CL Jr, Petroni GR, Olson WC, Smolkin ME, Ross MI, Haas NB, et al. Effect of GM-CSF on circulating CD8+ and CD4+ T cell responses to a multipeptide melanoma vaccine: outcome of a multicenter randomized trial. Clin Cancer Res 2009;15:7036-44.
65. Moodie Z, Price L, Gouttefangeas C, Mander A, Janetzki S, Löwer M, et al. Response definition criteria for ELISPOT assays revisited. Cancer Immunol Immunother 2010;59:1489-501.
66. Dubey S, Clair J, Fu TM, Guan L, Long R,MoggR, et al. Detection of HIV vaccine-induced cell-mediated immunity in HIV-seronegative clinical trial participants using an optimized and validated enzyme-linked immunospot assay. J Acquir Immune Defic Syndr 2007;45:20-7. (Pubitemid 46684439)
67. Brazma A, Hingamp P, Quackenbush J, Sherlock G, Spellman P, Stoeckert C, et al. Minimum information about a microarray experiment (MIAME)-toward standards for microarray data. Nat Genet 2001;29:365-71. (Pubitemid 34326681)
68. Available from: http://www.miataproject.org.
69. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005;97:1180-4. (Pubitemid 41258223)
70. Alvarez DF, Helm K, Degregori J, Roederer M, Majka S. Publishing flow cytometry data. Am J Physiol Lung Cell Mol Physiol 2010;298: L127-30.
71. Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, et al. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 2007;30:1-15. (Pubitemid 46052199)
72. Available from: http://mibbi.org/index.php/MIBBI-portal.
73. Available from: http://www.mibbi.org.
74. Janetzki S, Britten CM, Kalos M, Levitsky HI, Maecker HT, Melief CJ, et al. "MIATA"-minimal information about T cell assays. Immunity 2009;31:527-8.
75. Lee JA, Spidlen J, Boyce K, Cai J, Crosbie N, Dalphin M, et al. MIFlowCyt: the minimum information about a Flow Cytometry Experiment. Cytometry A 2008;73:926-30.
76. Spidlen J, Moore W, Parks D, Goldberg M, Bray C, Bierre P, et al. Data File Standard for Flow Cytometry, version FCS 3.1. Cytometry A 2010;77:97-100.
77. Taylor CF, Field D, Sansone SA, Aerts J, Apweiler R, Ashburner M, et al. Promoting coherent minimum reporting guidelines for biological and biomedical investigations: the MIBBI project. Nat Biotechnol 2008;26:889-96.
78. [cited 2009]. Available from: www.fda.gov/biologicsbloodvaccines/ guidancecomplianceregulatoryinformation/default.htm.
79. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfCFR/CFRSearch.cfm.
80. Cox JH, Ferrari G, Janetzki S. Measurement of cytokine release at the single cell level using the ELISPOT assay. Methods 2006;38: 274-82.
81. Xu Y, Theobald V, Sung C, DePalma K, Atwater L, Seiger K, et al. Validation of a HLA-A2 tetramer flow cytometric method, IFNgamma real time RT-PCR, and IFNgamma ELISPOT for detection of immunologic response to gp100 and MelanA/MART-1 in melanoma patients. J Transl Med 2008;6:61.
82. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, et al. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One 2010;5:e9015.
83. Roederer M, Koup RA. Optimized determination of T cell epitope responses. J Immunol Methods 2003;274:221-8. (Pubitemid 36263057)
84. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15:7412-20.
85. Kalos M. An integrative paradigm to impart quality to correlative science. J Transl Med 2010;8:26.
86. Available from: http://www.moffitt.org/Site.aspx?spid= C54AF116F69244D49BACE202F69BC2A6.
87. Gaseitsiwe S, Valentini D, Mahdavifar S, Magalhaes I, Hoft DF, Zerweck J, et al. Pattern recognition in pulmonary tuberculosis defined by high content peptide microarray chip analysis representing 61 proteins from M. tuberculosis. PLoS One 2008;3: e3840.
88. Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce- Pagès C, et al. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science 2006;313: 1960-4. (Pubitemid 44498003)
89. Chaussabel D, Ueno H, Banchereau J, Quinn C. Data management: it starts at the bench. Nat Immunol 2009;10:1225-7.
90. Butterfield LH, Disis ML, Khleif SN, Balwit JM, Marincola F. Immunooncology biomarkers 2010 and beyond: Perspectives from the iSBTc/SITC Biomarker Task Force. J Transl Med 2010;8:130.
91. Disis ML, dela Rosa C, Goodell V, Kuan LY, Chang JC, Kuus-Reichel K, et al. Maximizing the retention of antigen specific lymphocyte function after cryopreservation. J Immunol Methods 2006; 308:13-8. (Pubitemid 43107950)
92. Maecker HT, Moon J, Bhatia S, Ghanekar SA, Maino VC, Payne JK, et al. Impact of cryopreservation on tetramer, cytokine flow cytometry, and ELISPOT. BMC Immunol 2005;6:17.
93. Available from: http://aactg.org/about-actg.
94. Available from: http://iqa.center.duke.edu/modules/dhvi-iqa/index.php?id= 1.