Needle-free dermal delivery of a diphtheria toxin CRM197 mutant on potassium-doped hydroxyapatite microparticles

Clinical and Vaccine Immunology

Volumn 22, Issue 5, 2015, Pages 586-592

  Weissmueller, Nikolas T ^a,b,c   Schiffter, Heiko A ^b   Carlisle, Robert C ^b   Rollier, Christine S ^a,c   Pollard, Andrew J ^a,c  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM POTASSIUM SULFATE; DIPHTHERIA TOXOID CRM197; HYDROXYAPATITE; IMMUNOGLOBULIN G1 ANTIBODY; IMMUNOGLOBULIN G2A ANTIBODY; POTASSIUM; POTASSIUM DOPED HYDROXYAPATITE MICROPARTICLE; UNCLASSIFIED DRUG; BACTERIAL PROTEIN; BACTERIUM ANTIBODY; CRM197 (NON-TOXIC VARIANT OF DIPHTHERIA TOXIN); DIPHTHERIA TOXIN; DRUG CARRIER; IMMUNOGLOBULIN G;

ADSORPTION; ALPHA HELIX; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY TITER; ANTIGEN PRESENTATION; ARTICLE; BAGG ALBINO MOUSE; CONTROLLED STUDY; DIPHTHERIA; DRUG DELIVERY SYSTEM; FEMALE; GEOMETRIC MEAN TITER; IN VITRO STUDY; INOCULATION; MOUSE; NEEDLE FREE DERMAL DELIVERY; NONHUMAN; POWDER; PRIORITY JOURNAL; REFERENCE VALUE; SUSTAINED DRUG RELEASE; ANIMAL; BLOOD; CHEMISTRY; CUTANEOUS DRUG ADMINISTRATION; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; NEEDLE; PROCEDURES;

ADMINISTRATION, CUTANEOUS; ADSORPTION; ANIMALS; ANTIBODIES, BACTERIAL; BACTERIAL PROTEINS; DIPHTHERIA TOXIN; DRUG CARRIERS; DRUG DELIVERY SYSTEMS; DURAPATITE; FEMALE; IMMUNOGLOBULIN G; INJECTIONS, INTRAMUSCULAR; MICE; MICE, INBRED BALB C; NEEDLES; POTASSIUM;

EID: 84929093433     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00121-15     Document Type: Article

References (44)

1. Varmus H, Klausner R, Zerhouni E, Acharya T, Daar AS, Singer PA. 2003. Grand challenges in global health. Science 302:398-399. http://dx.doi.org/10.1126/science.1091769.
2. Guo YL, Shiao J, Chuang YC, Huang KY. 1999. Needlestick and sharps injuries among health-care workersin Taiwan. Epidemiol Infect 122:259-265. http://dx.doi.org/10.1017/S0950268899002186.
3. Rapiti E, Prüss-Üstün A, Hutin Y. 2005. Sharps injuries: assessing the burden of disease from sharps injuries to health-care workers at national and local levels. World Health Organization, Geneva, Switzerland.
4. Hopkins C. 2012. Needlestick injuries. Nurs Stand 27(3):59.
5. World Health Organization. 2004. Safety of injections: global facts and figures. World Health Organization, Geneva, Switzerland.
6. Mitragotri S. 2005. Immunization without needles. Nat Rev Immunol 5:905-916. http://dx.doi.org/10.1038/nri1728.
7. Sullivan SP, Koutsonanos DG, Del Pilar Martin M, Lee JW, Zarnitsyn V, Choi SO, Murthy N, Compans RW, Skountzou I, Prausnitz MR. 2010. Dissolving polymer microneedle patches for influenza vaccination. Nat Med 16:915-920. http://dx.doi.org/10.1038/nm.2182.
8. Prausnitz MR, Langer R. 2008. Transdermal drug delivery. Nat Biotechnol 26:1261-1268. http://dx.doi.org/10.1038/nbt.1504.
9. Fang WJ, Qi W, Kinzell J, Prestrelski S, Carpenter JF. 2012. Effects of excipients on the chemical and physical stability of glucagon during freeze-drying and storage in dried formulations. Pharm Res 29:3278-3291. http://dx.doi.org/10.1007/s11095-012-0820-7.
10. Wang W. 2000. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 203:1-60. http://dx.doi.org/10.1016/S0378-5173 (00) 00423-3.
11. Wang W. 2005. Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm 289:1-30. http://dx.doi.org/10.1016/j.ijpharm.2004.11.014.
12. Kersten G, Hirschberg H. 2007. Needle-free vaccine delivery. Expert Opin Drug Deliv 4:459-474. http://dx.doi.org/10.1517/17425247.4.5.459.
13. Weissmueller NT, Schiffter HA, Pollard AJ. 2013. Intradermal powder immunization with protein-containing vaccines. Expert Rev Vaccines 12:687-702. http://dx.doi.org/10.1586/erv. 13.48.
14. Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. 2008. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA 299:173-184. http://dx.doi.org/10.1001/jama.2007.29-c.
15. Pollard AJ, Perrett KP, Beverley PC. 2009. Maintaining protection against invasive bacteria with protein-polysaccharide conjugate vaccines. Nat Rev Immunol 9:213-220. http://dx.doi.org/10.1038/nri2494.
16. Lindblad EB. 2004. Aluminium compounds for use in vaccines. Immunol Cell Biol 82:497-505. http://dx.doi.org/10.1111/j.0818-9641.2004.01286.x.
17. Chen D, Erickson CA, Endres RL, Periwal SB, Chu Q, Shu C, Maa YF, Payne LG. 2001. Adjuvantation of epidermal powder immunization. Vaccine 19:2908-2917. http://dx.doi.org/10.1016/S0264-410X (00) 00544-2.
18. Chen DX, Kristensen D. 2009. Opportunities and challenges of developing thermostable vaccines. Expert Rev Vaccines 8:547-557. http://dx.doi.org/10.1586/erv. 09.20.
19. Maa YF, Ameri M, Shu C, Payne LG, Chen D. 2004. Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation. J Pharm Sci 93:1912-1923. http://dx.doi.org/10.1002/jps.20104.
20. Maa YF, Shu C, Ameri M, Zuleger C, Che J, Osorio JE, Payne LG, Chen D. 2003. Optimization of an alum-adsorbed vaccine powder formulation for epidermal powder immunization. Pharm Res 20:969-977. http://dx.doi.org/10.1023/A:1024493719236.
21. Maa YF, Ameri M, Shu C, Zuleger CL, Che J, Osorio JE, Payne LG, Chen D. 2007. Hepatitis-b surface antigen (hbsag) powder formulation: process and stability assessment. Curr Drug Deliv 4:57-67. http://dx.doi.org/10.2174/156720107779314758.
22. Marsee DK, Williams JM, Velazquez EF. 2008. Aluminum granuloma after administration of the quadrivalent human papillomavirus vaccine. Report of a case. Am J Dermatopathol 30:622-624. http://dx.doi.org/10.1097/DAD.0b013e318185a691.
23. Verron E, Khairoun I, Guicheux J, Bouler JM. 2010. Calcium phosphate biomaterials as bone drug delivery systems: a review. Drug Discov Today 15:547-552. http://dx.doi.org/10.1016/j.drudis.2010.05.003.
24. Ginebra MP, Canal C, Espanol M, Pastorino D, Montufar EB. 2012. Calcium phosphate cements as drug delivery materials. Adv Drug Deliv Rev 64:1090-1110. http://dx.doi.org/10.1016/j.addr.2012.01.008.
25. Yin G, Liu Z, Zhan J, Ding FX, Yuan NJ. 2002. Impacts of the surface charge property on protein adsorption on hydroxyapatite. Chem Eng J 87:181-186. http://dx.doi.org/10.1016/S1385-8947 (01) 00248-0.
26. Shen JW, Wu T, Wang Q, Pan HH. 2008. Molecular simulation of protein adsorption and desorption on hydroxyapatite surfaces. Biomaterials 29:513-532. http://dx.doi.org/10.1016/j.biomaterials.2007.10.016.
27. Jiang DP, Premachandra GS, Johnston C, Hem SL. 2004. Structure and adsorption properties of commercial calcium phosphate adjuvant. Vaccine 23:693-698. http://dx.doi.org/10.1016/j.vaccine.2004.06.029.
28. Costigan G, Liu Y, Brown GL, Carter FV, Bellhouse BJ. 2005. Evolution of the design of Venturi devices for the delivery of dry particles to skin or mucosal tissue, p 719-724. In Jiang Z (ed), Shock waves. Proceedings of the 24th International Symposium on Shock Waves, Beijing, China, 11 to 16 July 2004. Springer-Verlag, Berlin, Germany.
29. Malito E, Bursulaya B, Chen CN, Lo Surdo P, Picchianti M, Balducci E, Biancucci M, Brock A, Berti F, Bottomley MJ, Nissum M, Costantino P, Rappuoli R, Spraggon G. 2012. Structural basis for lack of toxicity of the diphtheria toxin mutant CRM197. Proc Natl Acad Sci U S A 109:5229-5234. http://dx.doi.org/10.1073/pnas.1201964109.
30. Shinefield HR. 2010. Overview of the development and current use of crm197 conjugate vaccines for pediatric use. Vaccine 28:4335-4339. http://dx.doi.org/10.1016/j.vaccine.2010.04.072.
31. Kanra G, Viviani S, Yurdakok K, Ozmert E, Anemona A, Yalcin S, Demiralp O, Bilgili N, Kara A, Cengiz AB, Mutlu B, Baldini A, Marchetti E, Podda A. 2003. Effect of aluminum adjuvants on safety and immunogenicity of Haemophilus influenzae type b-crm197 conjugate vaccine. Pediatr Int 45:314-318. http://dx.doi.org/10.1046/j.1442-200X.2003.01706.x.
32. Viswanath B, Raghavan R, Gurao NP, Ramamurty U, Ravishankar N. 2008. Mechanical properties of tricalcium phosphate single crystals grown by molten salt synthesis. Acta Biomater 4:1448-1454. http://dx.doi.org/10.1016/j.actbio.2008.02.031.
33. Dean HJ, Fuller D, Osorio JE. 2003. Powder and particle-mediated approaches for delivery of DNA and protein vaccines into the epidermis. Comp Immunol Microbiol Infect Dis 26:373-388. http://dx.doi.org/10.1016/S0147-9571 (03) 00021-3.
34. Kendall M, Mitchell T, Wrighton-Smith P. 2004. Intradermal ballistic delivery of micro-particles into excised human skin for pharmaceutical applications. J Biomech 37:1733-1741. http://dx.doi.org/10.1016/j.jbio mech.2004.01.032.
35. Kendall M, Rishworth S, Carter F, Mitchell T. 2004. Effects of relative humidity and ambient temperature on the ballistic delivery of microparticles to excised porcine skin. J Investig Dermatol 122:739-746. http://dx.doi.org/10.1111/j.0022-202X.2004.22320.x.
36. Kendall MAF, Chong Y-F, Cock A. 2007. The mechanical properties of the skin epidermis in relation to targeted gene and drug delivery. Biomaterials 28:4968-4977. http://dx.doi.org/10.1016/j.biomaterials.2007.08.006.
37. Hartvig RA, Van De Weert M, Ostergaard J, Jorgensen L, Jensen H. 2011. Protein adsorption at charged surfaces: the role of electrostatic interactions and interfacial charge regulation. Langmuir 27:2634-2643. http://dx.doi.org/10.1021/la104720n.
38. Weissmueller NT, Schiffter HA, Pollard AJ, Cuneyt TA. 2014. Molten salt synthesisofpotassium-containing hydroxyapatite microparticles used as protein substrate. Mater Lett 128:421-424. http://dx.doi.org/10.1016/j.matlet.2014.04.154.
39. Fink AL. 1998. Protein aggregation: folding aggregates, inclusion bodies and amyloid. Fold Des 3:R9-R23. http://dx.doi.org/10.1016/S1359-0278 (98) 00002-9.
40. Mavropoulos E, Costa AM, Costa LT, Achete CA, Mello A, Granjeiro JM, Rossi AM. 2011. Adsorption and bioactivity studies of albumin onto hydroxyapatite surface. Colloids SurfBBiointerfaces 83:1-9. http://dx.doi.org/10.1016/j.colsurfb.2010.10.025.
41. Den Engelsman J, Garidel P, Smulders R, Koll H, Smith B, Bassarab S, Seidl A, Hainzl O, Jiskoot W. 2011. Strategies for the assessment of protein aggregates in pharmaceutical biotech product development. Pharm Res 28:920-933. http://dx.doi.org/10.1007/s11095-010-0297-1.
42. Rosenberg AS. 2006. Effects of protein aggregates: an immunologic perspective. AAPS J 8:E501-E507. http://dx.doi.org/10.1208/aapsj080359.
43. Plotkin SA. 2010. Correlates of protection induced by vaccination. Clin Vaccine Immunol 17:1055-1065. http://dx.doi.org/10.1128/CVI.00131-10.
44. Peters GH, Van Aalten DM, Edholm O, Toxvaerd S, Bywater R. 1996. Dynamics of proteins in different solvent systems: analysis of essential motion in lipases. Biophys J 71:2245-2255. http://dx.doi.org/10.1016/S0006-3495 (96) 79428-6.