A recombinant 63-kDa form of Bacillus anthracis protective antigen produced in the yeast Saccharomyces cerevisiae provides protection in rabbit and primate inhalational challenge models of anthrax infection

Vaccine

Volumn 24, Issue 10, 2006, Pages 1501-1514

  Hepler, Robert W ^a   Kelly, Rosemarie ^a   McNeely, Tessie B ^a   Fan, Hongxia ^a   Losada, Maria C ^a   George, Hugh A ^a   Woods, Andrea ^a   Cope, Leslie D ^a   Bansal, Alka ^a   Cook, James C ^a   Zang, Gina ^a,c   Cohen, Steven L ^a   Wei, Xiaorong ^a   Keller, Paul M ^a   Leffel, Elizabeth ^b   Joyce, Joseph G ^a   Pitt, Louise ^b   Schultz, Loren D ^a   Jansen, Kathrin U ^a,d   Kurtz, Myra ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

^c GENENTECH INC   (United States)

^d VaxGen Inc   (United States)

Author keywords

Anthrax; Protective antigen; Vaccine

Indexed keywords

ANTHRAX VACCINE; BACTERIAL ANTIGEN; EPITOPE; HYBRID PROTEIN; RECOMBINANT ANTIGEN; RECOMBINANT PROTECTIVE ANTIGEN; RECOMBINANT VACCINE; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTHRAX; ANTIGEN EXPRESSION; ANTIGEN PURIFICATION; ARTICLE; BACILLUS ANTHRACIS; BACTERIAL INFECTION; BACTERIAL SPORE; BACTERIAL STRAIN; BIOLOGICAL ACTIVITY; CELL KILLING; CODON; CONTROLLED STUDY; CORRELATION ANALYSIS; DENATURATION; DISEASE MODEL; ESCHERICHIA COLI; FEMALE; IMMUNIZATION; IN VIVO STUDY; INFECTION CONTROL; INHALATION; LETHAL DOSE; MACROPHAGE; MALE; MOLECULAR WEIGHT; NONHUMAN; NUCLEOTIDE SEQUENCE; PRIMATE; PRIORITY JOURNAL; PROTECTION; PROVOCATION TEST; RABBIT; SACCHAROMYCES CEREVISIAE; YEAST;

AMINO ACID SEQUENCE; ANIMALS; ANTHRAX; ANTHRAX VACCINES; ANTIGENS, BACTERIAL; BACTERIAL TOXINS; CODON; FEMALE; MACACA MULATTA; MALE; MOLECULAR SEQUENCE DATA; RABBITS; RECOMBINANT PROTEINS; SACCHAROMYCES CEREVISIAE; VACCINES, SYNTHETIC;

EID: 32544454306     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2005.10.018     Document Type: Article

References (75)

1. S.F. Little, and B.E. Ivins Molecular pathogenesis of Bacillus anthracis infection Microbes Infect 1 2 1999 131 139
2. A.M. Friedlander Anthrax: clinical features, pathogenesis, and potential biological warfare threat Curr Clin Top Infect Dis 20 2000 335 349
3. M. Mock, and A. Fouet Anthrax Annu Rev Microbiol 55 2001 647 671
4. D.B. Lacy, and R.J. Collier Structure and function of anthrax toxin Curr Top Microbiol Immunol 271 2002 61 85
5. R.J. Collier, and A.T. Young Anthrax toxin Annu Rev Cell Dev Biol 2003 45 70
6. S.H. Leppla Anthrax toxin K. Aktories I. Just Bacterial protein toxins 2000 Springer Berlin 445 472
7. K.H. Ibrahim, G. Brown, D.H. Wright, and J.C. Rotschafer Bacillus anthracis: medical issues of biologic warfare Pharmacotherapy 19 6 1999 690 701
8. A.M. Friedlander, S.L. Welkos, and B.E. Ivins Anthrax vaccines Curr Top Microbiol Immunol 271 2002 33 60
9. S.H. Leppla, J.B. Robbins, R. Schneerson, and J. Shiloach Development of an improved vaccine for anthrax J Clin Invest 110 2 2002 141 144
10. P.C. Turnbull Anthrax vaccines: past, present and future Vaccine 9 8 1991 533 539
11. P.C. Turnbull, S.H. Leppla, M.G. Broster, C.P. Quinn, and J. Melling Antibodies to anthrax toxin in humans and guinea pigs and their relevance to protective immunity Med Microbiol Immunol 177 5 1988 293 303
12. L. Baillie The development of new vaccines against Bacillus anthracis J Appl Microbiol 91 4 2001 609 613
13. B.E. Ivins, M.L. Pitt, P.F. Fellows, J.W. Farchaus, G.E. Benner, and D.M. Waag Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques Vaccine 16 11-12 1998 1141 1148
14. P.F. Fellows, M.K. Linscott, B.E. Ivins, M.L. Pitt, C.A. Rossi, and P.H. Gibbs 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 23-24 2001 3241 3247
15. A.J. Phipps, C. Premanandan, R.E. Barnewall, and M.D. Lairmore Rabbit and nonhuman primate models of toxin-targeting human anthrax vaccines Microbiol Mol Biol Rev 68 4 2004 617 629
16. D. Kobiler, Y. Gozes, H. Rosenberg, D. Marcus, S. Reuveny, and Z. Altboum Efficiency of protection of guinea pigs against infection with Bacillus anthracis spores by passive immunization Infect Immun 70 2 2002 544 550
17. R.J. Beedham, P.C. Turnbull, and E.D. Williamson Passive transfer of protection against Bacillus anthracis infection in a murine model Vaccine 19 31 2001 4409 4416
18. N. Mohamed, M. Clagett, J. Li, S. Jones, S. Pincus, and G. D'Alia A high-affinity monoclonal antibody to anthrax protective antigen passively protects rabbits before and after aerosolized Bacilllus anthracis spore challenge Infect Immun 73 2 2005 795 802
19. S. Reuveny, M.D. White, Y.Y. Adar, Y. Kafri, Z. Altboum, and Y. Gozes Search for correlates of protective immunity conferred by anthrax vaccine Infect Immun 69 5 2001 2888 2893
20. R. Sawada-Hirai, I. Jiang, F. Wang, S. Sun, R. Nedellec, and P. Ruther Human anti-anthrax protective antigen neutralizing monoclonal antibodies derived from donors vaccinated with anthrax vaccine adsorbed J. Immune Based Therapies Vaccines 2 1 2004 5
21. G.M. Subramanian, P.W. Cronin, G. Poley, A. Weinstein, S.M. Stoughton, and J. Zhong A phase 1 study of PAmAb, a fully human monoclonal antibody against Bacillus anthracis protective antigen, in healthy volunteers Clin Infect Dis 41 1 2005 12 20
22. T. Jefferson, V. Demicheli, J. Deeks, P. Graves, M. Pratt, and D. Rivetti Vaccines for preventing anthrax Cochrane Database Syst Rev 2 2000 CD000975
23. H.C. Flick-Smith, N.J. Walker, P. Gibson, H. Bullifent, S. Hayward, and J. Miller A recombinant carboxy-terminal domain of the protective antigen of Bacillus anthracis protects mice against anthrax infection Infect Immun 70 3 2002 1653 1656
24. Y. Singh, K.R. Klimpel, C.P. Quinn, V.K. Chaudhary, and S.H. Leppla The carboxyl-terminal end of protective antigen is required for receptor binding and anthrax toxin activity J Biol Chem 266 23 1991 15493 15497
25. B.E. Ivins, and S.L. Welkos Recent advances in the development of an improved, human anthrax vaccine Eur J Epidemiol 4 1 1988 12 19
26. J.S. Lee, A.G. Hadjipanayis, and S.L. Welkos Venezuelan equine encephalitis virus-vectored vaccines protect mice against anthrax spore challenge Infect Immun 71 3 2003 1491 1496
27. M.E. Ferrari, G. Hermanson, and A. Rolland Development of anthrax DNA vaccines Curr Opin Mol Ther 6 5 2005 506 512
28. U.K. Hahn, M. Alex, C. Czerny, R. Bohm, and W. Beyer Protection of mice against challenge with Bacillus anthracis STI spores after DNA vaccination Int J Med Microbiol 294 2004 35 44
29. D. Galloway, A. Liner, J. Legutki, A. Mateczun, R. Barnewall, and J. Estep Genetic immunization against anthrax Vaccine 22 2004 1604 1608
30. J.Y. Wang, and M.H. Roehrl Anthrax vaccine design: strategies to achieve comprehensive protection against spore, bacillus, and toxin Med Immunol 4 1 2005 4 11
31. P. Gupta, S.M. Waheed, and R. Bhatnagar Expression and purification of the recombinant protective antigen of Bacillus anthracis Protein Expr Purif 16 3 1999 369 376
32. V. Chauhan, A. Singh, S.M. Waheed, S. Singh, and R. Bhatnagar Constitutive expression of protective antigen gene of Bacillus anthracis in Escherichia coli Biochem Biophys Res Commun 283 2 2001 308 315
33. M. Sharma, P.K. Swain, A.P. Chopra, V.K. Chaudhary, and Y. Singh Expression and purification of anthrax toxin protective antigen from Escherichia coli Protein Expr Purif 7 1 1996 33 38
34. M.W. Laird, D. Zukauskas, K. Johnson, G.C. Sampey, H. Olsen, and A. Garcia Production and purification of Bacillus anthracis protective antigen from Escherichia coli Protein Expr Purif 38 1 2004 145
35. W. Gwinn, M. Zhang, S. Mon, D. Sampey, D. Zukauskas, and C. Kassebaum Scalable purification of Bacillus anthracis protective antigen from Escherichia coli Protein Expr Purif 45 2006 30 36
36. J. Watson, V. Koya, S.H. Leppla, and H. Daniell Expression of Bacillus anthracis protective antigen in transgenic chloroplasts of tobacco, a non-food/feed crop Vaccine 22 2004 4374 4384
37. M.R. Hilleman Recombinant yeast hepatitis B vaccine Dev Biol Stand 63 1986 57 62
38. K.H. Fife, C.M. Wheeler, L.A. Koutsky, E. Barr, D.R. Brown, and M.A. Schiff Dose-ranging studies of the safety and immunogenicity of human papillomavirus Type II and Type 16 virus-like particle candidate vaccines in young healthy women Vaccine 22 2004 2943 2952
39. L.A. Koutsky, K.A. Ault, C.M. Wheeler, D.R. Brown, E. Barr, and F.B. Alvarez A controlled trial of a human papillomavirus type 16 vaccine New Engl J Med 347 21 2002 1645 1651
40. M.J. DeWilde Yeast as a host for the production of macromolecules of prophylactic or therapeutic interest in human health care Bioprocess Technol 5 1990 479 504
41. T.D. Read, S.N. Peterson, N. Tourasse, L.W. Baillie, I.T. Paulsen, and K.E. Nelson The genome sequence of Bacillus anthracis Ames and comparison to closely related bacteria Nature 423 6935 2003 81 86
42. E.L. Benson, P.D. Huynh, A. Finkelstein, and R.J. Collier Identification of residues lining the anthrax protective antigen channel Biochemistry 37 11 1998 3941 3948
43. K.J. Hofmann, J.C. Cook, J.G. Joyce, D.R. Brown, L.D. Schultz, and H.A. George Sequence determination of human papilloma virus type 6a and assembly of virus-like particles in Saccharomyces cerevisiae Virology 209 1995 506 518
44. J.C. Cook, L.D. Schultz, J. Huang, H.A. George, W.K. Herber, and C. Ip Expression and purification of recombinant tick anticoagulant peptide (Y1W/D10R) double mutant secreted by Saccharomyces cerevisiae Protein Expr Purif 13 1998 291 300
45. M.L. Bayne, J. Applebaum, G.G. Chicchi, N.S. Hayes, B.G. Green, and M.A. Cascieri Expression, purification and characterization of recombinant human insulin-like growth factor I in yeast Gene 66 1988 235 244
46. C.E. Carty, F.X. Kovach, W.J. McAleer, and R.Z. Maigetter Fermentation of recombinant yeast producing hepatitis B surface antigen J Ind Microbiol 2 1987 117 121
47. E. Oura Effect of aeration intensity on the biochemical composition of baker's yeast. I. Factors affecting the type of metabolism Biotechnol Bioeng 16 1974 1197 1212
48. T.J. Leighton, and R.H. Doi The stability of messenger ribonucleic acid during sporulation in Bacillus subtilis J Biol Chem 246 10 1971 3189 3195
49. R.O. Blaustein, T.M. Koehler, R.J. Collier, and A. Finkelstein Anthrax toxin: channel-forming activity of protective antigen in planar phospholipid bilayers Proc Natl Acad Sci USA 86 7 1989 2209 2213
50. A. Hinnen, J.B. Hicks, and G.R. Fink Transformation of yeast Proc Nat Acad Sci USA 75 4 1978 1929 1933
51. M.M. Bradford A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding Anal Biochem 72 1976 248 254
52. P.K. Gupta, H. Chandra, R. Gaur, R.K. Kurupati, S. Chowdhury, and V. Tandon Conformational fluctuations in anthrax protective antigen: a possible role of calcium in the folding pathway of the protein FEBS Lett 554 3 2003 505 510
53. J. Slavik Anilinonapthalene sulfonate as a probe of membrane composition and function Biochim Biophys Acta 694 1 1982 1 25
54. E. Sentandreu, J.V. Carbonell, and J.M. Sendra Monitoring of chemical and enzymatic hydrolysis of water-soluble proteins using flow-injection analysis with fluorescence detection and an aqueous eluant containing 2-p-toluidinylnapthalene-6-sulfonate as the fluorescent probe Biotechnol Bioeng 78 7 2002 829 833
55. T.M. Koehler, and R.J. Collier Anthrax toxin protective antigen: low-pH-induced hydrophobicity and channel formation in liposomes Mol Microbiol 5 6 1991 1501 1506
56. N. Sreerama, and R.W. Woody Computation and analysis of protein circular dichroism spectra Methods Enzymol 383 2004 318 351
57. M. Cadene, and B.T. Chait A robust, detergent-friendly method for mass spectrometric analysis of integral membrane proteins Anal Chem 72 22 2000 5655 5658
58. G. Tang, and S.H. Leppla Proteasome activity is required for anthrax lethal toxin to kill macrophages Infect Immun 67 6 1999 3055 3060
59. A.M. Friedlander, S.L. Welkos, M.L. Pitt, J.W. Ezzell, P.L. Worsham, and K.J. Rose Postexposure prophylaxis against experimental inhalation anthrax J Infect Dis 167 5 1993 1239 1243
60. K.R. May The collison nebulizer, description, performance and applications J Aerosol Sci 4 1973 235 243
61. A. Agresti Categorical data analysis 1990 Wiley-Interscience New York
62. S.L. Welkos, J.R. Lowe, F. Eden-McCutchan, M. Vodkin, S.H. Leppla, and J.J. Schmidt Sequence and analysis of the DNA encoding protective antigen of Bacillus anthracis Gene 69 2 1988 287 300
63. P.M. Sharp, and E. Cowe Synonymous codon usage in Saccharomyces cerevisiae Yeast 7 7 1991 657 678
64. M.A. Romanos, C.A. Scorer, and J.J. Clare Foreign gene expression in yeast: a review Yeast 8 6 1992 423 488
65. J.C. Miller, and J.N. Miller Statistics for analytical chemistry 1993 Ellis Horwood PTR Prentice Hall New York
66. R.G. Panchal, K. Halverson, W. Ribot, D. Lane, T. Kenny, and T. Abshire Purified Bacillus anthracis lethal toxin complex formed in-vitro and during infection exhibits functional and biological activity J Biol Chem 280 11 2005 10834 10839
67. J.W. Ezzell, and T.G. Abshire Serum protease cleavage of Bacillus anthracis protective antigen J Gen Microbiol 138 Pt 3 1992 543 549
68. I. Grotto, Y. Mandel, M. Ephros, I. Ashkenazi, and J. Shemer Major adverse reactions to yeast-derived hepatitis B vaccines - a review Vaccine 16 4 1998 329 334
69. L. DiMiceli, V. Pool, S.V. Shadomy, and J. Iskander Anaphylaxis following recombinant hepatitis B vaccines in yeast-sensitive individuals: reports to VAERS Eighth annual conference on vaccine research, 2005 Baltimore, MD 2005
70. B. Polevoda, and F. Sherman N-terminal acetylation of eukaryotic proteins J Biol Chem 275 47 2000 36479 36482
71. D.M. Ramirez, S.H. Leppla, R. Schneerson, and J. Shiloach Production, recovery, and immunogenicity of the protective antigen from a recombinant strain of Bacillus anthracis J Ind Microbiol Biotechnol 28 2002 232 238
72. D.C. Turner, and L. Brand Quantitative estimation of protein binding site polarity. Fluorescence of N-arylaminonapthalenesulfonates Biochemistry 7 1968 3381 3390
73. B.E. Ivins, J.W. Ezzell Jr., J. Jemski, K.W. Hedlund, J.D. Ristroph, and S.H. Leppla Immunization studies with attenuated strains of Bacillus anthracis Infect Immun 52 2 1986 454 458
74. G. Hermanson, V. Whitlow, S. Parker, K. Tonsky, D. Rusalov, and M. Ferrari A cationic lipid-formulated plasmid DNA vaccine confers sustained antibody-mediated protection against aeorsolized anthrax spores PNAS 101 37 2004 13601 13606
75. B.A. Aulinger, M.H. Roehrl, J.J. Mekalanos, R.J. Collier, and J.Y. Wang Combining anthrax vaccine and therapy: a dominant-negative inhibitor of anthrax toxin is also a potent and safe immunogen for vaccines Infect Immun 73 6 2005 3408 3414