Results of an ELISPOT proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials

AIDS Research and Human Retroviruses

Volumn 21, Issue 1, 2005, Pages 68-81

  Cox, Josephine H ^a   Ferrari, Guido ^b   Kalams, Spyros A ^c   Lopaczynski, Wlodek ^d   Oden, Neal ^e   D'Souza, M Patricia ^f   Cao, Huyen ^g   McNicholl, Janet ^h   Koup, Richard ⁱ   Gray, Clive ^j   Horton, Helen ^k   Pantaleo, Giuseppe ^l   Gillmour, Jill ^m   Bernard, Nicole ⁿ   Hudgens, Michael ^o   Janetzki, Sylvia ^p   Lehmann, Paul ^q   Tary Lehmann, Magdalena ^q   Cosentino, Mark ^d   Turk, Ellen ^a   Hedgepeth, Alicia ^b   more..

^a US Military HIV Research Program   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^d BBI Biotech Research Laboratories   (United States)

^e EMMES CORPORATION   (United States)

^f NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^g U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^h CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

ⁱ NATIONAL INSTITUTES OF HEALTH   (United States)

^j NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

^k FHCRC   (United States)

^l European Vaccine Initiative   (Switzerland)

^m INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

ⁿ Canadian Vaccine Initiative (CANVAC)   (Canada)

^o Fred Hutchinson Cancer Research Center   (United States)

^p ZellNet Consulting   (United States)

^q Cellular Technology Limited   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GAMMA INTERFERON; HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; CELL VIABILITY; CLINICAL PROTOCOL; CONTROLLED STUDY; ENZYME LINKED IMMUNOSPOT ASSAY; HUMAN; HUMAN CELL; IMMUNOGENICITY; IMMUNOSTIMULATION; LABORATORY; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUALITY CONTROL; STANDARDIZATION; STATISTICAL ANALYSIS;

AIDS VACCINES; CLINICAL TRIALS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HIV INFECTIONS; HIV-1; HUMANS; INTERFERON TYPE II; LABORATORIES; LEUKOCYTES, MONONUCLEAR; LYMPHOCYTE ACTIVATION; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS;

EID: 19944431341     PISSN: 08892229     EISSN: None     Source Type: Journal    
DOI: 10.1089/aid.2005.21.68     Document Type: Article

References (70)

1. Plotkin S: Vaccines, vaccination, and vaccinology. J Infect Dis 2003;187:1349-1359.
2. Esser MT, Marchese RD, Kierstead LS, Tussey LG, Wang F, Chirmule N, and Washabaugh MW: Memory T cells and vaccines. Vaccine 2003;21:419-430.
3. Esparza J, Chang M-L, Widdus R, Madrid Y, Walker N, and Ghys PD: Estimation of "needs" and "probable uptake" for HIV/AIDS preventive vaccines based on possible policies and likely acceptance (a WHO/UNAIDS/IAVI study). Vaccine 2003;21:2032-2041.
4. Harrer E, Harrer T, Barbosa P, Feinberg M, Johnson R, Buchbinder S, and Walker B: Recognition of the highly conserved YMDD region in the human immunodeficiency virus type 1 reverse transcriptase by HLA-A2-restricted cytotoxic T lymphocytes from an asymptomatic long-term nonprogressor. J Infect Dis 1996;173:476-479.
5. Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkwosky W, Farthing C, and Ho DD: Temporal association of cellular immune responses with the initial viremia in primary human immunodeficiency virus type 1 syndrome. J Virol 1994;68:4650-4655.
6. Rowland-Jones S, Sutton J, Ariyoshi K, Dong T, Gotch F, McAdam S, et al.: HIV-specific cytotoxic T-cells in HIV-exposed but uninfected Gambian women. Nat Med 1995;1:59-64.
7. Jin X, Bauer D, Tuttleton S, Lewin S, Gettie A, Blanchard J, et al.: Dramatic rise in plasma viremia after CD8(+) T cell depletion in simian immunodeficiency virus-infected macaques. J Exp Med 1999;189:991-998.
8. Schmitz JE, Kuroda MJ, Santra S, Sasseville VG, Simon M, Lifton M, et al.: Control of viremia in Simian immunodeficiency virus infection by CD8+ lymphocytes. Science 1999;283:857-860.
9. D'Souza MP, Allen MA, and Johnston MI: HIV vaccines: Biological and clinical considerations. Curr Infect Dis Rep 2002;4:359-368.
10. McMichael A and Hanke T: The quest for an AIDS vaccine; is the CD8+ T-cell approach feasible? Nat Immunol 2002;2:283-291.
11. Robinson H: New hope for an AIDS vaccine. Nat Rev Immunol 2002;2:239-250.
12. Spearman P: HIV vaccine development: Lessons from the past and promise for the future. Curr HIV Res 2003;1:101-120.
13. Amara R, Villinger F, Altman J, Lydy S, O'Neil S, Staprans S, et al.: Control of a mucosal challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. Science 2001;292:69-74.
14. Barouch DH, Santra S, Kuroda MJ, Schmitz JE, Plishka R, Buckler-White A, et al.: Reduction of Simian-human immunodeficiency virus 89.6P viremia in rhesus monkeys by recombinant modified vaccinia virus Ankara vaccination. J Virol 2001;75:5151-5158.
15. Shiver J, Fu T, Chen L, Casimiro D, Davies M, Evans R, et al.: Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 2002;415:331-335.
16. Evans T, Keefer M, Weinhold K, Wolff M, Montefiori D, Gorse G, et al.: A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis 1999;180:290-298.
17. Beishe R, Stevens C, Gorse G, Buchbinder S, Weinhold K, Sheppard H, et al.: Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus type 1 vaccine with or without gp120: A phase 2 study in higher- and lower-risk volunteers. J Infect Dis 2001;183:1343-1352.
18. Berencsi K, Gyulai Z, Gonczol E, Pincus S, Cox W, Michelson S, et al.: A canarypox vector-expressing cytomegalovirus (CMV) phosphoprotein 65 induces long-lasting cytotoxic T cell responses in human CMV-seronegative subjects. J Infect Dis 2001;183:1171-1179.
19. McConkey S, Reece W, Moorthy V, Webster D, Dunachie S, Bulcher G, et al.: Enhanced T-cell immunogenicity of plasmid DNA vaccines boosted by recombinant modified vaccinia virus Ankara in humans. Nat Med 2003;9:729-735.
20. Evans T, Kallas E, Campbell M, Andrews J, Schwartz D, Keefer M, and Caudrelier P: Evaluation of canarypox-induced CD8(+) responses following immunization by measuring the effector population IFNgamma production. Immunol Lett 2001;77:7-15.
21. Cohen J: Disappointing data scuttle plans for large-scale AIDS vaccine trial. Science 2002;295:1616-1617.
22. Moore J: AIDS vaccines: On the trail of two trials. Nature 2002;415:365-366.
23. Whiteside T: Immunologic monitoring of clinical trials in patients with cancer: Technology versus common sense. Immunol Invest 2000;29:149-162.
24. Klausner RD, Fauci AS, Corey L, Nabel GJ, Gayle H, et al.: The need for a global HIV vaccine enterprise. Science 2003;300:2036-2039.
25. Clay T, Hobeika A, Mosca P, Lyerly H, and Morse M: Assays for monitoring cellular immune responses to active immunotherapy of cancer. Clin Cancer Res 2001;7:1127-1135.
26. Hickling J: Measuring T-lymphocyle function. Expert Rev Mol Med 1998;1-20.
27. Kaul R and Rowland-Jones SL: Methods of detection of HIV-specific CTL and their role in protection against HIV infection. Vol. 1999: HIV Molecular Immunology Database, http://hiv-web.lanl.gov/immuno.
28. Mashishi T and Gray CM: The ELISPOT assay: An easily transferable method for measuring cellular responses and identifying T cell epitopes. Clin Chem Lab Med 2002;40:1-7.
29. McMichael AJ and O'Callagan NK: A new look at T cells. J Exp Med 1998;43:1367-1371.
30. Czerkinsky CC, Andersson G, Ekre HP, Nielsson LA, Klareskog L, and Ouchterlony O: Reverse ELISPOT assay for clonal analysis of cytokine production. Enumeration of gamma-interferon secreting cells. J Immunol Methods 1988;110:29-36.
31. Herr W, Protzer U, Lohse A, Gerken G, Meyer Zum Buschenfelde K, and Wolfel T: Quantification of CD8+ T lymphocytes responsive to human immunodeficiency virus (HIV) peptide antigens in HIV-infected patients and seronegative persons at high risk for recent HIV exposure. J Infect Dis 1998;178:260-265.
32. Addo MM, Yu XG, Rathod A, Cohen D, Eldridge RL, Strick D, et al.: Comprehensive epitope analysis of human immunodeficiency virus type 1 (HIV-1)-specific T-cell responses directed against the entire expressed HIV-1 genome demonstrate broadly directed responses, but no correlation to viral load. J Virol 2003;77:2081-2092.
33. Draenert R, Altfeld M, Brander C, Basgoz N, Corcoran C, Wurcel AG, et al.: Comparison of overlapping peptide sets for detection of antiviral CD8 and CD4 T cell responses. J Immunol Methods 2003;275:19-29.
34. Smith JG, Liu X, Kaufhold RM, Clair J, and Caulfield MJ: Development and validation of a gamma interferon ELISPOT assay for quantitation of cellular immune responses to varicella-zoster virus. Clin Diagn Lab Immunol 2001;8:871-879.
35. Kumaraguru U and Rouse B: Application of the intracellular gamma interferon assay to recalculate the potency of CD8(+) T-cell responses to herpes simplex virus. J Virol 2000;74:5709-5711.
36. Flanagan K, Lee E, Gravenor M, Reece W, Urban B, Doherty T, et al.: Unique T cell effector functions elicited by Plasmodium falciparum epitopes in malaria-exposed Africans tested by three T cell assays. J Immunol 2001;167:4729-4737.
37. Elkington R, Walker S, Crough T, Menzies M, Tellam J, Bharadwaj M, and Khanna R: Ex vivo profiling of CD8+-T-cell responses to human cytomegalovirus reveals broad and multispecific reactivities in healthy virus carriers. J Virol 2003;77:5226-5240.
38. Gahery-Segard H, Pialoux G, Charmeteau B, Sermet S, Poncelet H, Raux M, et al.: Multiepitopic B- and T-cell responses induced in humans by a human immunodeficiency virus type 1 lipopeptide vaccine. J Virol 2000;74:1694-1703.
39. Boyer J, Cohen A, Vogt S, Schumann K, Nath B, Ahn L, et al.: Vaccination of seronegative volunteers with a human immunodeficiency virus type 1 env/rev DNA vaccine induces antigen-specific proliferation and lymphocyte production of beta-chemokines. J Infect Dis 2000;181:476-483.
40. Moss R, Diveley J, Jensen F, Gouveia E, Savary J, and Carlo D: HIV-specific CD4(+) and CD8(+) immune responses are generated with a gp120-depleted, whole-killed HIV-1 immunogen with CpG immunostimulatory sequences of DNA. J Interferon Cytokine Res 2000;20:1131-1137.
41. Ariyoshi K, Promadej N, Ruxrungthan K, and Sutthent R: Toward improved evaluation of cytotoxic T lymphocyte (CTL)-inducing HIV vaccines in Thailand. AIDS Res Hum Retroviruses 2002;18:737-739.
42. Cao H, Kaleebu P, Hom D, Flores J, Agrawal D, Jones N, et al.: Immunogenicity of a recombinant human immunodeficiency virus (HIV)-canarypox vaccine in HIV-seronegative Ugandan volunteers: Results of the HIV Network for Prevention Trials 007 Vaccine Study. J Infect Dis 2003;187:887-895.
43. Russell ND, Hudgens MG, Ha R, Havenar-Daughton C, and McElrath MJ: Moving to HIV-1 vaccine efficacy trials: Defining T cell responses as potential correlates of immunity. J Infect Dis 2003;187:226-242.
44. Mwau M, McMichael A, and Hanke T: Design and validation of an enzyme-linked immunospot assay for use in clinical trials of candidate HIV vaccines. AIDS Res Hum Retroviruses 2002;18:611-618.
45. Lathey J: Preliminary steps toward validating a clinical bioassay. BioPharm Int 2003;42-50.
46. Currier J, Kuta E, Turk E, Earhart L, Loomis-Price L, Janetzki S, Ferrari G, Birx D, and Cox J: A panel of MHC class I restricted viral peptides for use as a quality control for vaccine trial ELISPOT assays. J Immunol Methods 2002;260:157-172.
47. Kreher CR, Dittrich MT, Guerkov R, Boehm BO, and Tary-Lehmann M: CD4+ and CD8+ cells in cryopreserved human PBMC maintain full functionality in cytokine ELISPOT assays. J Immunol Methods 2003;278:79-93.
48. Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, Wee EG-T, et al.: A human immunodeficiency virus 1 (HIV-1) clade A vaccine in clinical trials: Stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol 2004;85:911-919.
49. Westfall PH, Tobias RD, Rom D, Wolfinger D, and Hochberg Y: Multiple comparisons and multiple tests using the SAS system: SAS Institute Inc, Cary, NC, 1999.
50. Westfall PH and Young SS: Resampling-Based Multiple Testing: Examples and Methods for P-Value Adjustment Wiley, New York, 1993.
51. Hudgens MG, Self S, Chiu Y-L, Russell ND, Horton H, and McElrath MJ: Statistical considerations for the design and analysis of the ELISPOT assay in HIV-1 vaccine trials. J Immunol Methods 2004;288:19-34.
52. Feldkamp CS and Carey JL: Standardization of immunoassay methodologies. In: Manual of Clinical Laboratory Immunology (Rose N, Hamilton R, and Detrick B, eds.), 6th Ed. ASM Press, Washington D.C., 2002, pp. 1215-1226.
53. Lynn F, Reed G, and Meade B: Collaborative study for the evaluation of enzyme-linked immunosorbent assays used to measure human antibodies to Bordetella pertussis antigens. Clin Diagn Lab Immunol 1996;3:689-700.
54. Gheesling L, Carlone G, Pais L, Holder P, Maslanka S, Plikaytis B, et al.: Multicenter comparison of Neisseria meningitidis serogroup C anti-capsular polysaccharide antibody levels measured by a standardized enzyme-linked immunosorbent assay. J Clin Microbiol 1994;32:1475-1482.
55. Madore D, Anderson P, Baxter B, Carlone G, Edwards K, Hamilton R, et al.: Interlaboratory study evaluating quantitation of antibodies to Haemophilus influenzae type b polysaccharide by enzyme-linked immunosorbent assay. Clin Diagn Lab Immunol 1996;3:84-88.
56. Homburger H, Rosenstock W, Paxton H, Paton M, and Landay A: Assessment of interlaboratory variability of immunophenotyping. Results of the College of American Pathologists Flow Cytometry Survey. Ann NY Acad Sci 1993;677:43-49.
57. Reilly JT and Barnett D: UK NEQAS for leukocyte immunophenotyping: The first 10 years. J Clin Pathol 2001;54:508-511.
58. Scheibenbogen C, Romero P, Rivoltini L, Herr W, Schmittel A, Cerottini J, et al.: Quantitation of antigen-reactive T cells in peripheral blood by IFNgamma-ELISPOT assay and chromium-release assay: A four-centre comparative trial. J Immunol Methods 2000;244:81-89.
59. Sun Y, Iglesias E, Samri A, Kamkamidze G, Decoville T, Carcelain G, and Autran B: A systematic comparison of methods to measure HIV-1 specific CD8 T cells. J Immunol Methods 2003;272:23-34.
60. ICH: Guideline for Industry. Text on Validation of Analytical Procedures, Vol. 2004. International Congress on Harmonization, 1995. http://www.fda.gov/ cder/guidance/ichq2a.pdf.
61. ICH: Guidance for Industry. Q2B Validation of Analytical Procedures: Methodology. International Congress on Harmonization, 1996. http://www.fda.gov/ cder/guidance/1320fnl.pdf.
62. Weinberg A, Zhang L, Brown D, Erice A, Polsky B, Hirsch M, et al.: Viability and functional activity of cryopreserved mononuclear cells. Clin Diagn Lab Immunol 2000;7:714-716.
63. Cox J, deSouza M, Ratto-Kim S, Ferrari G, Weinhold K, and Birx D: Accomplishing cellular immune assays for evaluation of vaccine efficacy in developing countries. In: Manual of Clinical Laboratory Immunology (Rose N, Hamilton R, and Detrick B, eds.), 6th Ed. ASM Press, Washington D.C., 2002, pp. 301-315.
64. Kleeberger C, Lyles R, Margolick J, Rinaldo C, Phair J, and Giorgi J: Viability and recovery of peripheral blood mononuclear cells cryopreserved for up to 12 years in a multicenter study. Clin Diagn Lab Immunol 1999;6:14-19.
65. Cox JH, Ferrari G, Bailer RT, and Koup RA: Automating procedures for processing, cryopreservation, storage and manipulation of human peripheral blood mononuclear cells. J Assoc Lab Automat 2004;9:16-23.
66. Lem L: Cell counting and viability assessments in the process development of cellular therapeutics. BioProcessing J 2003;July/August:57-60.
67. Herr W, Linn B, Leister N, Wandel E, Meyer zum Buschenfelde KH, and Wolfel T: The use of computer-assisted video image analysis for the quantification of CD8+ T lymphocytes producing tumor necrosis factor alpha spots in response to peptide antigens. J Immunol Methods 1997;203:141-152.
68. Cui Y and Chang L: Computer-assisted, quantitative cytokine enzyme-linked immunospot analysis of human immune effector cell function. Biotechniques 1997;22:1146-1149.
69. McMichael A and Hanke T: HIV vaccines 1983-2003. Nat Med 2003;9:874-880.
70. FDA: Code of Federal Regulations, Part 58. Good laboratory practice for nonclinical laboratory studies, 2002. http://www.access.gpo.gov/nara/cfr/waisidx 01/21cfr58_01.html.