Stable dry powder formulation for nasal delivery of anthrax vaccine

Journal of Pharmaceutical Sciences

Volumn 101, Issue 1, 2012, Pages 31-47

  Wang, Sheena H ^a,c   Kirwan, Shaun M ^b,d   Abraham, Soman N ^b   Staats, Herman F ^b   Hickey, Anthony J ^a  

^a University of North Carolina   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c Novartis Vaccines Global Engineering   (United States)

^d DUKE UNIVERSITY   (United States)

Author keywords

Biopharmaceuticals characterization; Biotechnology; Mucosal immunization; Protein formulation; Spray freeze drying; Vaccine adjuvants; Vaccine delivery

Indexed keywords

ANTHRAX VACCINE; NEUTRALIZING ANTIBODY;

ANIMAL EXPERIMENT; ARTICLE; CELL ASSAY; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRY POWDER; FEMALE; FREEZE DRYING; IMMUNE RESPONSE; IMMUNIZATION; INFRARED SPECTROSCOPY; NONHUMAN; ROOM TEMPERATURE;

EID: 82255174961     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22742     Document Type: Article

References (49)

1. Bhatnagar R, Batra S. 2001. Anthrax toxin. Crit Rev Microbiol 27(3):167-200.
2. Sternbach G. 2003. The history of anthrax. J Emerg Med 24(4):463-467.
3. Jernigan DB, Raghunathan PL, Bell BP, Brechner R, Bresnitz EA, Butler JC, Cetron M, Cohen M, Doyle T, Fischer M, Greene C, Griffith KS, Guarner J, Hadler JL, Hayslett JA, Meyer R, Petersen LR, Phillips M, Pinner R, Popovic T, Quinn CP, Reefhuis J, Reissman D, Rosenstein N, Schuchat A, Shieh WJ, Siegal L, Swerdlow DL, Tenover FC, Traeger M, Ward JW, Weisfuse I, Wiersma S, Yeskey K, Zaki S, Ashford DA, Perkins BA, Ostroff S, Hughes J, Fleming D, Koplan JP, Gerberding JL. 2002. Investigation of bioterrorism-related anthrax, United States, 2001: Epidemiologic findings. Emerg Infect Dis 8(10):1019-1028.
4. Friedlander AM. 2000. Anthrax: Clinical features, pathogenesis, and potential biological warfare threat. Curr Clin Top Infect Dis 20:335-349.
5. CDC. 2000. Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices.
6. Welkos S, Friedlander A, Weeks S, Little S, Mendelson I. 2002. In-vitro characterisation of the phagocytosis and fate of anthrax spores in macrophages and the effects of anti-PA antibody. J Med Microbiol 51(10):821-831.
7. Welkos S, Little S, Friedlander A, Fritz D, Fellows P. 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.
8. Brown BK, Cox J, Gillis A, VanCott TC, Marovich M, Milazzo M, Antonille TS, Wieczorek L, McKee KT Jr., MetCalfe K, Mallory RM, Birx D, Polonis VR, Robb ML. Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults 2010, 5(11), e13849
9. Flick-Smith HC, Eyles JE, Hebdon R, Waters EL, Beedham RJ, Stagg TJ, Miller J, Alpar HO, Baillie LW, Williamson ED. 2002. Mucosal or parenteral administration of microsphere-associated Bacillus anthracis protective antigen protects against anthrax infection in mice. Infect Immun 70(4):2022-2028.
10. Mikszta JA, Sullivan VJ, Dean C, Waterston AM, Alarcon JB, Dekker JP III, Brittingham JM, Huang J, Hwang CR, Ferriter M, Jiang G, Mar K, Saikh KU, Stiles BG, Roy CJ, Ulrich RG, Harvey NG. 2005. Protective immunization against inhalational anthrax: A comparison of minimally invasive delivery platforms. J Infect Dis 191(2):278-288.
11. Keitel WA. 2006. Recombinant protective antigen 102 (rPA102): Profile of a second-generation anthrax vaccine. Expert Rev Vaccines 5(4):417-430.
12. Gorse GJ, Keitel W, Keyserling H, Taylor DN, Lock M, Alves K, Kenner J, Deans L, Gurwith M. 2006. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: A randomized, double-blinded, controlled, multicenter trial. Vaccine 24(33-34):5950-5959.
13. Illum L, Jabbal-Gill I, Hinchcliffe M, Fisher AN, Davis SS. 2001. Chitosan as a novel nasal delivery system for vaccines. Adv Drug Deliv Rev 51(1-3):81-96.
14. Kemble G, Greenberg H. 2003. Novel generations of influenza vaccines. Vaccine 21(16):1789-1795.
15. Boyaka PN, Tafaro A, Fischer R, Leppla SH, Fujihashi K, McGhee JR. 2003. Effective mucosal immunity to anthrax: Neutralizing antibodies and Th cell responses following nasal immunization with protective antigen. J Immunol 170(11):5636-5643.
16. Debin A, Kravtzoff R, Santiago JV, Cazales L, Sperandio S, Melber K, Janowicz Z, Betbeder D, Moynier M. 2002. Intranasal immunization with recombinant antigens associated with new cationic particles induces strong mucosal as well as systemic antibody and CTL responses. Vaccine 20(21-22):2752-2763.
17. Gaur R, Gupta PK, Banerjea AC, Singh Y. 2002. Effect of nasal immunization with protective antigen of Bacillus anthracis on protective immune response against anthrax toxin. Vaccine 20(21-22):2836-2839.
18. Rharbaoui F, Drabner B, Borsutzky S, Winckler U, Morr M, Ensoli B, Muhlradt PF, Guzman CA. 2002. The Mycoplasma-derived lipopeptide MALP-2 is a potent mucosal adjuvant. Eur J Immunol 32(10):2857-2865.
19. Staats HF, Bradney CP, Gwinn WM, Jackson SS, Sempowski GD, Liao HX, Letvin NL, Haynes BF. 2001. Cytokine requirements for induction of systemic and mucosal CTL after nasal immunization. J Immunol 167(9):5386-5394.
20. Plant A, Williams NA. 2004. Modulation of the immune response by the cholera-like enterotoxins. Curr Top Med Chem 4(5):509-519.
21. Holmgren J, Harandi AM, Czerkinsky C. 2003. Mucosal adjuvants and anti-infection and anti-immunopathology vaccines based on cholera toxin, cholera toxin B subunit and CpG DNA. Expert Rev Vaccines 2(2):205-217.
22. Kodama S, Abe N, Hirano T, Suzuki M. 2006. Safety and efficacy of nasal application of CpG oligodeoxynucleotide as a mucosal adjuvant. Laryngoscope 116(2):331-335.
23. van Ginkel FW, Jackson RJ, Yuki Y, McGhee JR. 2000. Cutting edge: The mucosal adjuvant cholera toxin redirects vaccine proteins into olfactory tissues. J Immunol 165(9):4778-4782.
24. Galli SJ, Nakae S, Tsai M. 2005. Mast cells in the development of adaptive immune responses. Nat Immunol 6(2):135-142.
25. Nakae S, Suto H, Kakurai M, Sedgwick JD, Tsai M, Galli SJ. 2005. Mast cells enhance T cell activation: Importance of mast cell-derived TNF. Proc Natl Acad Sci U S A 102(18):6467-6472.
26. Mazzoni A, Siraganian RP, Leifer CA, Segal DM. 2006. Dendritic cell modulation by mast cells controls the Th1/Th2 balance in responding T cells. J Immunol 177(6):3577-3581.
27. McLachlan JB, Shelburne CP, Hart JP, Pizzo SV, Goyal R, Brooking-Dixon R, Staats HF, Abraham SN. 2008. Mast cell activators: A new class of highly effective vaccine adjuvants. Nat Med 14(5):536-541.
28. Staats HF, Fielhauer JR, Thompson AL, Tripp AA, Sobel AE, Maddaloni M, Abraham SN, Pascual DW. Mucosal targeting of a BoNT/A subunit vaccine adjuvanted with a mast cell activator enhances induction of BoNT/A neutralizing antibodies in rabbits. PLoS One 6(1):e16532.
29. Anderson J, Fishbourne E, Corteyn A, Donaldson AI. 2000. Protection of cattle against rinderpest by intranasal immunisation with a dry powder tissue culture vaccine. Vaccine 19(7-8):840-843.
30. Garmise RJ, Staats HF, Hickey AJ. 2007. Novel dry powder preparations of whole inactivated influenza virus for nasal vaccination. AAPS PharmSciTech 8(4):E81.
31. LiCalsi C, Maniaci MJ, Christensen T, Phillips E, Ward GH, Witham C. 2001. A powder formulation of measles vaccine for aerosol delivery. Vaccine 19(17-19):2629-2636.
32. Garmise RJ, Mar K, Crowder TM, Hwang CR, Ferriter M, Huang J, Mikszta JA, Sullivan VJ, Hickey AJ. 2006. Formulation of a dry powder influenza vaccine for nasal delivery. AAPS PharmSciTech 7(1):E19.
33. Jiang G, Joshi SB, Peek LJ, Brandau DT, Huang J, Ferriter MS, Woodley WD, Ford BM, Mar KD, Mikszta JA, Hwang CR, Ulrich R, Harvey NG, Middaugh CR, Sullivan VJ. 2006. Anthrax vaccine powder formulations for nasal mucosal delivery. J Pharm Sci 95(1):80-96.
34. Montemurro P, Nishioka H, Dundon WG, de Bernard M, Del Giudice G, Rappuoli R, Montecucco C. 2002. The neutrophil-activating protein (HP-NAP) of Helicobacter pylori is a potent stimulant of mast cells. Eur J Immunol 32(3):671-676.
35. Staats HF, Alam SM, Scearce RM, Kirwan SM, Zhang JX, Gwinn WM, Haynes BF. 2007. In vitro and in vivo characterization of anthrax anti-protective antigen and anti-lethal factor monoclonal antibodies after passive transfer in a mouse lethal toxin challenge model to define correlates of immunity. Infect Immun 75(11):5443-5452.
36. Hancock BC, Shamblin SL, Zografi G. 1995. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm Res 12(6):799-806.
37. Naini V, Byron PR, Phillips EM. 1998. Physicochemical stability of crystalline sugars and their spray-dried forms: Dependence upon relative humidity and suitability for use in powder inhalers. Drug Dev Ind Pharm 24(10):895-909.
38. Crowe LM, Reid DS, Crowe JH. 1996. Is trehalose special for preserving dry biomaterials? Biophys J 71(4):2087-2093.
39. Krittanai C, Johnson WC. 1997. Correcting the circular dichroism spectra of peptides for contributions of absorbing side chains. Anal Biochem 253(1):57-64.
40. Schule S, Friess W, Bechtold-Peters K, Garidel P. 2007. Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations. Eur J Pharm Biopharm 65(1):1-9.
41. Baltzly R, Dvorkovitz V, Phillips AP. 1949. Synthetic analogs of oxytocic drugs; phenethyl beta-alanine derivatives. J Am Chem Soc 71(4):1162-1164.
42. Read GW, Lenney JF. 1972. Molecular weight studies on the active constituents of compound 48-80. J Med Chem 15(3):320-323.
43. Ortner MJ, Sik RH, Chignell CF, Sokoloski EA. 1979. A nuclear magnetic resonance study of compound 48/80. Mol Pharmacol 15(1):179-188.
44. Paton WD. 1951. Compound 48/80: A potent histamine liberator. Br J Pharmacol Chemother 6(3):499-508.
45. Koibuchi Y, Ichikawa A, Nakagawa M, Tomita K. 1985. Histamine release induced from mast cells by active components of compound 48/80. Eur J Pharmacol 115(2-3):163-170.
46. Hall JB, Hino GN, Inouye L, Nada A, Lau CK, Read GW. 1983. Antimicrobial action of compound 48/80-II mechanism of action. Biochem Pharmacol 32(3):449-453.
47. Young JA, Collier RJ. 2007. Anthrax toxin: Receptor binding, internalization, pore formation, and translocation. Annu Rev Biochem 76:243-265.
48. Gwinn WM, Kirwan SM, Wang SH, Ashcraft KA, Sparks NL, Doil CR, Tlusty TG, Casey LS, Hollingshead SK, Briles DE, Dondero RS, Hickey AJ, Foster WM, Staats HF. Effective induction of protective systemic immunity with nasally administered vaccines adjuvanted with IL-1. Vaccine 28(42):6901-6914.
49. Li H, Soroka SD, Taylor TH Jr., Stamey KL, Stinson KW, Freeman AE, Abramson DR, Desai R, Cronin LX, Oxford JW, Caba J, Pleatman C, Pathak S, Schmidt DS, Semenova VA, Martin SK, Wilkins PP, Quinn CP. 2008. Standardized, mathematical model-based and validated in vitro analysis of anthrax lethal toxin neutralization. J Immunol Methods 333(1-2):89-106.