Comparison of three anthrax toxin neutralization assays

Clinical and Vaccine Immunology

Volumn 17, Issue 6, 2010, Pages 895-903

  Ngundi, Miriam M ^a   Meade, Bruce D ^b   Lin, Tsai Lien ^a   Tang, Wei Jen ^c   Burns, Drusilla L ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b Meade Biologics   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM; ANTHRAX TOXIN; ANTHRAX VACCINE; FC RECEPTOR; NEUTRALIZING ANTIBODY; RECOMBINANT ANTIGEN;

ANIMAL CELL; ANIMAL EXPERIMENT; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CELL ASSAY; CELL HETEROGENEITY; CHO CELL; CONTROLLED STUDY; HUMAN; HUMAN VERSUS ANIMAL COMPARISON; IMMUNOASSAY; INTERMETHOD COMPARISON; MOUSE; NONHUMAN; PRIMATE; PRIORITY JOURNAL; RABBIT; SIGNAL TRANSDUCTION; SPECIES COMPOSITION; TOXIN NEUTRALIZING ASSAY;

ANIMALS; ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ANTIBODIES, NEUTRALIZING; ANTIGENS, BACTERIAL; BACILLUS ANTHRACIS; BACTERIAL TOXINS; CELL LINE; CHO CELLS; CRICETINAE; CRICETULUS; EPITHELIAL CELLS; HUMANS; MACACA FASCICULARIS; MACROPHAGES; MICE; NEUTRALIZATION TESTS; RABBITS; RECOMBINANT PROTEINS; SPECIES SPECIFICITY; VACCINES, SYNTHETIC;

EID: 77953154332     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00513-09     Document Type: Article

References (36)

1. Baldari, C. T., F. Tonello, S. R. Paccani, and C. Montecucco. 2006. Anthrax toxins: a paradigm of bacterial immune suppression. Trends Immunol. 27:434-440.
2. Chen, Z., M. Moayeri, D. Crown, S. Emerson, I. Gorshkova, P. Schuck, S. H. Leppla, and R. H. Purcell. 2009. Novel chimpanzee/human monoclonal antibodies that neutralize anthrax lethal factor, and evidence for possible synergy with anti-protective antigen antibody. Infect. Immun. 77:3902-3908.
3. Collier, R. J., and J. A. Young. 2003. Anthrax toxin. Annu. Rev. Cell Dev. Biol. 19:45-70.
4. Dang, O., L. Navarro, K. Anderson, and M. David. 2004. Cutting edge: anthrax lethal toxin inhibits activation of IFN-regulatory factor 3 by lipopolysaccharide. J. Immunol. 172:747-751.
5. Duesbery, N. S., C. P. Webb, S. H. Leppla, V. M. Gordon, K. R. Klimpel, T. D. Copeland, N. G. Ahn, M. K. Oskarsson, K. Fukasawa, K. D. Paull, and G. F. Vande Woude. 1998. Proteolytic inactivation of MAP-kinase-kinase by anthrax lethal factor. Science 280:734-737.
6. FDA. 2002. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Fed. Regist. 67:37988-37998.
7. FDA. 2007. Anthrax: Bridging Correlates of Protection in Animals to Immunogenicity in Humans. Transcript of a workshop. http://www.fda.gov/cber/ minutes/workshop-min.htm.
8. Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. Pitt, C. A. Rossi, P. H. Gibbs, and A. M. Friedlander. 2001. Efficacy of a human anthrax vaccine in guinea pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse geographical origin. Vaccine 19:3241-3247.
9. Gorse, G. J., W. Keitel, H. Keyserling, D. N. Taylor, M. Lock, K. Alves, J. Kenner, L. Deans, and M. Gurwith. 2006. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA 102) anthrax vaccine: a randomized, double-blinded, controlled, multicenter trial. Vaccine 24:5950-5959.
10. Hering, D., W. Thompson, J. Hewetson, S. Little, S. Norris, and J. Pace-Templeton. 2004. Validation of the anthrax lethal toxin neutralization assay. Biologicals 32:17-27.
11. Ivins, B. E., M. L. Pitt, P. F. Fellows, J. W. Farchaus, G. E. Benner, D. M. Waag, S. F. Little, G. W. Anderson, Jr., P. H. Gibbs, and A. M. Friedlander. 1998. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine 16:1141-1148.
12. Leppla, S. H. 1982. Anthrax toxin edema factor: a bacterial adenylate cyclase that increases cyclic AMP concentrations in eukaryotic cells. Proc. Natl. Acad. Sci. U. S. A. 79:3162-3166.
13. Li, H., S. D. Soroka, T. H. Taylor, K. L. Stamey, K. W. Stinson, A. E. Freeman, D. R. Abramson, R. Desai, L. X. Cronin, J. W. Oxford, J. Caba, C. Pleatman, S. Pathak, D. S. Schmidt, V. A. Semenova, S. K. Martin, P. P. Wilkins, and C. P. Quinn. 2008. Standardized, mathematical model-based and validated in vitro analysis of anthrax lethal toxin neutralization. J. Immunol. Methods 333:89-106.
14. Li, Y., K. Sherer, X. Cui, and P. Q. Eichacker. 2007. New insights into the pathogenesis and treatment of anthrax toxin-induced shock. Expert Opin. Biol. Ther. 7:843-854.
15. Little, S. F., B. E. Ivins, P. F. Fellows, and A. M. Friedlander. 1997. Passive protection by polyclonal antibodies against Bacillus anthracis infection in guinea pigs. Infect. Immun. 65:5171-5175.
16. Little, S. F., B. E. Ivins, P. F. Fellows, M. L. Pitt, S. L. Norris, and G. P. Andrews. 2004. Defining a serological correlate of protection in rabbits for a recombinant anthrax vaccine. Vaccine 22:422-430.
17. Little, S. F., W. M. Webster, B. E. Ivins, P. F. Fellows, S. L. Norris, and G. P. Andrews. 2004. Development of an in vitro-based potency assay for anthrax vaccine. Vaccine 22:2843-2852.
18. Moayeri, M., and S. H. Leppla. 2004. The roles of anthrax toxin in pathogenesis. Curr. Opin. Microbiol. 7:19-24.
19. Mohamed, N., J. Li, C. S. Ferreira, S. F. Little, A. M. Friedlander, G. L. Spitalny, and L. S. Casey. 2004. Enhancement of anthrax lethal toxin cytotoxicity: a subset of monoclonal antibodies against protective antigen increases lethal toxin-mediated killing of murine macrophages. Infect. Immun. 72:3276-3283.
20. Omland, K. S., A. Brys, D. Lansky, K. Clement, F. Lynn, and Participating Laboratories. 2008. Interlaboratory comparison of results of an anthrax lethal toxin neutralization assay for assessment of functional antibodies in multiple species. Clin. Vaccine Immunol. 15:946-953.
21. Peachman, K. K., M. Rao, C. R. Alving, R. Burge, S. H. Leppla, V. B. Rao, and G. R. Matyas. 2006. Correlation between lethal toxin-neutralizing antibody titers and protection from intranasal challenge with Bacillus anthracis Ames strain spores in mice after transcutaneous immunization with recombinant anthrax protective antigen. Infect. Immun. 74:794-797.
22. Phipps, A. J., C. Premanandan, R. E. Barnewall, and M. D. Lairmore. 2004. Rabbit and nonhuman primate models of toxin-targeting human anthrax vaccines. Microbiol. Mol. Biol. Rev. 68:617-629.
23. Pitt, M. L., S. F. Little, B. E. Ivins, P. Fellows, J. Barth, J. Hewetson, P. Gibbs, M. Dertzbaugh, and A. M. Friedlander. 2001. In vitro correlate of immunity in a rabbit model of inhalational anthrax. Vaccine 19:4768-4773.
24. Quinn, C. P., P. M. Dull, V. Semenova, H. Li, S. Crotty, T. H. Taylor, E. Steward-Clark, K. L. Stamey, D. S. Schmidt, K. W. Stinson, A. E. Freeman, C. M. Elie, S. K. Martin, C. Greene, R. D. Aubert, J. Glidewell, B. A. Perkins, R. Ahmed, and D. S. Stephens. 2004. Immune responses to Bacillus anthracis protective antigen in patients with bioterrorism-related cutaneous or inhalation anthrax. J. Infect. Dis. 190:1228-1236.
25. Quinn, C. P., V. A. Semenova, C. M. Elie, S. Romero-Steiner, C. Greene, H. Li, K. Stamey, E. Steward-Clark, D. S. Schmidt, E. Mothershed, J. Pruckler, S. Schwartz, R. F. Benson, L. O. Helsel, P. F. Holder, S. E. Johnson, M. Kellum, T. Messmer, W. L. Thacker, L. Besser, B. D. Plikaytis, T. H. Taylor, Jr., A. E. Freeman, K. J. Wallace, P. Dull, J. Sejvar, E. Bruce, R. Moreno, A. Schuchat, J. R. Lingappa, S. K. Martin, J. Walls, M. Bronsdon, G. M. Carlone, M. Bajani-Ari, D. A. Ashford, D. S. Stephens, and B. A. Perkins. 2002. Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human immunoglobulin G antibodies to anthrax toxin protective antigen. Emerg. Infect. Dis. 8:1103-1110.
26. Rossi Paccani, S., F. Tonello, L. Patrussi, N. Capitani, M. Simonato, C. Montecucco, and C. T. Baldari. 2007. Anthrax toxins inhibit immune cell chemotaxis by perturbing chemokine receptor signalling. Cell. Microbiol. 9:924-929.
27. Soelaiman, S., B. Q. Wei, P. Bergson, Y. S. Lee, Y. Shen, M. Mrksich, B. K. Shoichet, and W. J. Tang. 2003. Structure-based inhibitor discovery against adenylyl cyclase toxins from pathogenic bacteria that cause anthrax and whooping cough. J. Biol. Chem. 278:25990-25997.
28. Subramanian, G. M., P. W. Cronin, G. Poley, A. Weinstein, S. M. Stoughton, J. Zhong, Y. Ou, J. F. Zmuda, B. L. Osborn, and W. W. Freimuth. 2005. A phase 1 study of PAmAb, a fully human monoclonal antibody against Bacillus anthracis protective antigen, in healthy volunteers. Clin. Infect. Dis. 41:12-20.
29. Unkeless, J. C. 1979. Characterization of a monoclonal antibody directed against mouse macrophage and lymphocyte Fc receptors. J. Exp. Med. 150:580-596.
30. Vasconcelos, D., R. Barnewall, M. Babin, R. Hunt, J. Estep, C. Nielsen, R. Carnes, and J. Carney. 2003. Pathology of inhalation anthrax in cynomolgus monkeys (Macaca fascicularis). Lab. Invest. 83:1201-1209.
31. Verma, A., M. M. Ngundi, B. D. Meade, R. De Pascalis, K. L. Elkins, and D. L. Burns. 2009. Analysis of the Fc gamma receptor-dependent component of neutralization measured by anthrax toxin neutralization assays. Clin. Vaccine Immunol. 16:1405-1412.
32. Vitale, L., D. Blanset, I. Lowy, T. O'Neill, J. Goldstein, S. Little, G. P. Andrews, G. Dorough, R. K. Taylor, and T. Keler. 2006. Prophylaxis and therapy of inhalational anthrax by a novel monoclonal antibody to protective antigen that mimics vaccine-induced immunity. Infect. Immun. 74:5840-5847.
33. Weiss, S., D. Kobiler, H. Levy, H. Marcus, A. Pass, N. Rothschild, and Z. Altboum. 2006. Immunological correlates of protection against intranasal challenge of Bacillus anthracis spores conferred by a protective antigen-based vaccine in rabbits. Infect. Immun. 74:394-398.
34. Welkos, S., S. Little, A. Friedlander, D. Fritz, and P. Fellows. 2001. The role of antibodies to Bacillus anthracis and anthrax toxin components in inhibiting the early stages of infection by anthrax spores. Microbiology 147(Pt 6):1677-1685.
35. Zaucha, G. M., M. L. Pitt, J. Estep, B. E. Ivins, and A. M. Friedlander. 1998. The pathology of experimental anthrax in rabbits exposed by inhalation and subcutaneous inoculation. Arch. Pathol. Lab. Med. 122:982-992.
36. Zmuda, J. F., L. Zhang, T. Richards, Q. Pham, D. Zukauskas, J. L. Pierre, M. W. Laird, J. Askins, and G. H. Choi. 2005. Development of an edema factor-mediated cAMP-induction bioassay for detecting antibody-mediated neutralization of anthrax protective antigen. J. Immunol. Methods 298:47-60.