Devices and formulations for pulmonary vaccination

Expert Opinion on Drug Delivery

Volumn 10, Issue 10, 2013, Pages 1383-1397

  Tonnis, Wouter F ^a   Lexmond, Anne J ^a   Frijlink, Henderik W ^a   De Boer, Anne H ^a   Hinrichs, Wouter L J ^a  

^a UNIVERSITY OF GRONINGEN   (Netherlands)

Author keywords

Aerosol; Dry powder inhaler; Nebulizer; Powder formulation; Respiratory delivery; Vaccine

Indexed keywords

VACCINE;

COST EFFECTIVENESS ANALYSIS; DRUG DELIVERY DEVICE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRY POWDER INHALER; HUMAN; IMMUNE RESPONSE; MEDICAL NEBULIZER; METERED DOSE INHALER; MUCOSAL IMMUNITY; NEBULIZATION; NEEDLE; NONHUMAN; POWDER; PULMONARY VACCINATION; REVIEW; VACCINATION;

ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DRUG ADMINISTRATION ROUTES; DRUG DELIVERY SYSTEMS; HUMANS; IMMUNITY, MUCOSAL; LUNG; NEBULIZERS AND VAPORIZERS; RESPIRATORY MUCOSA; VACCINATION; VACCINES;

EID: 84884538716     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2013.810622     Document Type: Review

References (94)

1. Falsey AR, Treanor JJ, Tornieporth N, et al. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis 2009;200:172-80
2. Plennevaux E, Sheldon E, Blatter M, et al. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: A preliminary report of two randomised controlled phase 2 trials. Lancet 2010;375:41-8
3. Amorij J-P, Kersten GF, Saluja V, et al. Towards tailored vaccine delivery: Needs, challenges and perspectives. J Control Release 2012;161:363-76
4. Blank F, Stumbles P, Von Garnier C. Opportunities and challenges of the pulmonary route for vaccination. Exp Opin Drug Deliv 2011;8:547-63
5. Smith DJ, Bot S, Dellamary L, et al. Evaluation of novel aerosol formulations designed for mucosal vaccination against influenza virus. Vaccine 2003;21:2805-12
6. Bennett JV, Fernandez de Castro J, Valdespino-Gomez JL, et al. Aerosolized measles and measles-rubella vaccines induce better measles antibody booster responses than injected vaccines: Randomized trials in Mexican schoolchildren. B World Health Organ 2002;80:806-12
7. De Castro JF, Bennett J V, Rincon HG, et al. Evaluation of immunogenicity and side effects of triple viral vaccine (MMR) in adults, given by two routes: Subcutaneous and respiratory (aerosol). Vaccine 2005;23:1079-84
8. Dilraj A, Sukhoo R, Cutts FT, et al. Aerosol and subcutaneous measles vaccine: Measles antibody responses 6 years after re-vaccination. Vaccine 2007;25:4170-4
9. Dilraj A, Cutts FT, De Castro JF, et al. Response to different measles vaccine strains given by aerosol and subcutaneous routes to schoolchildren: A randomised trial. Lancet 2000;355:798-803
10. Khanum S, Uddin N, Garelick H, et al. Comparison of Edmonston-Zagreb and Schwarz strains of measles vaccine given by aerosol or subcutaneous injection. Lancet 1987;1:150-3
11. Wong-Chew RM, Islas-Romero R, García-García MDL, et al. Induction of cellular and humoral immunity after aerosol or subcutaneous administration of Edmonston-Zagreb measles vaccine as a primary dose to 12-month-old children. J Infect Dis 2004;189:254-7
12. Wong-Chew RM, Islas-Romero R, García-García MDL, et al. Immunogenicity of aerosol measles vaccine given as the primary measles immunization to nine-month-old Mexican children. Vaccine 2006;24:683-90
13. Cutts FT, Clements CJ, Bennett J V. Alternative routes of measles immunization: A review. Biologicals 1997;25:323-38
14. Low N, Kraemer S, Schneider M, et al. Immunogenicity and safety of aerosolized measles vaccine: Systematic review and meta-analysis. Vaccine 2008;26:383-98
15. Waldman RH, Mann JJ, Small PA. Immunization against influenza prevention of illness in man by aerosolized inactivated vaccine. JAMA 1969;207:520-4
16. Waldman RH, Bond JO, Levitt LP, et al. An evaluation of influenza immunization: Influence of route of administration and vaccine strain. B World Health Organ 1969;41(3):543-8
17. Haigh W, Howell RW. The efficacy of the A2/Aichi/68 strain in inhaled influenza immunisation against the A/England/42/72 variant. J Soc Occup Med 1973;23:125-7
18. Holmgren J, Czerkinsky C. Mucosal immunity and vaccines. Nature Med 2005;11:S45-53
19. Nardelli-Haefliger D, Lurati F, Wirthner D, et al. Immune responses induced by lower airway mucosal immunisation with a human papillomavirus type 16 virus-like particle vaccine. Vaccine 2005;23:3634-41
20. Lu D, Hickey AJ. Pulmonary vaccine delivery. Expert Rev Vaccines 2007;6:213-26
21. Patton JS, Byron PR. Inhaling medicines: Delivering drugs to the body through the lungs. Nat Rev Drug Discov 2007;6:67-74
22. Frijlink HW, De Boer AH. Trends in the technology-driven development of new inhalation devices. Drug Discov Today 2005;2:47-57
23. A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices (PMV-001). ClinicalTrials.gov, 2013. Available from: Http://www.clinicaltrials. gov/ct2/show/NCT01557699? term=PMV-001&rank=1 [Last accessed 19 April 2013]
24. Lin W-H, Griffin DE, Rota PA, et al. Successful respiratory immunization with dry powder live-attenuated measles virus vaccine in rhesus macaques. Proc Natl Acad Sci USA 2011;108:2987-92 vaccine with two different DPIs.
25. Saluja V, Amorij J-P, Kapteyn JC, et al. A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation. J Control Release 2010;144:127-33
26. De Boer AH, Hagedoorn P, Westerman EM, et al. Design and in vitro performance testing of multiple air classifier technology in a new disposable inhaler concept (Twincer) for high powder doses. Eur J Pharm Sci 2006;28:171-8
27. Westerman EM, De Boer AH, Le Brun PPH, et al. Dry powder inhalation of colistin sulphomethate in healthy volunteers: A pilot study. Int J Pharm 2007;335:41-5
28. Westerman EM, De Boer AH, Le Brun PPH, et al. Dry powder inhalation of colistin in cystic fibrosis patients: A single dose pilot study. J Cyst Fibros 2007;6:284-92
29. Device-Reloadable. Manta Devices LLC, Cambridge, MA, USA, 2013.Available from: Http://www. mantadevices.com/Device-Reloadable. html [Last accessed 28 May 2013]
30. Friebel C, Steckel H. Single-use disposable dry powder inhalers for pulmonary drug delivery. Exp Opin Drug Deliv 2010;7:1359-72
31. Niven RW, Brain JD. Some functional aspects of air-jet nebulizers. Int J Pharm 1994;104:73-85
32. Stathopulos PB, Scholz GA, Hwang Y, et al. Sonication of proteins causes formation of aggregates that resemble amyloid. Protein Sci 2004;13:3017-27
33. Münster AB, Bendstrup E, Jensen JI, et al. Jet and ultrasonic nebulization of single chain urokinase plasminogen activator (scu-PA). J Aerosol Med 2000;13:325-33
34. Chambers L, Flosdorf E. The denaturation of proteins by sound waves of audible frequencies. J Biol Chem 1936;114:75-83
35. McCallion ONM, Taylor KMG, Thomas M, et al. Nebuliation of fluids of different physicochemical properties with air-jet and ultrasonic nebulizers. Pharm Res 1995;12:1682-8
36. MacNeish CF, Coates AL, Meisner D, et al. A comparison of pulmonary availability between Ventolin (albuterol) nebules and Ventolin (albuterol) respirator solution. Chest 1997;111:204-8
37. Coates AL, MacNeish CF, Meisner D, et al. The choice of jet nebulizer, nebulizing flow, and addition of albuterol affects the output of tobramycin aerosols. Chest 1997;111:1206-12
38. Le Brun PP, De Boer AH, Gjaltema D, et al. Inhalation of tobramycin in cystic fibrosis. Part 2: Optimization of the tobramycin solution for a jet and an ultrasonic nebulizer. Int J Pharm 1999;189:215-25
39. Lexmond AJ, Hagedoorn P, Frijlink HW, et al. Challenging the two-minute tidal breathing challenge test. J Aerosol Med Pulm D 2013;Published online 20 March 2013; doi:10.1089/jamp.2012.1021
40. De Boer AH, Hagedoorn P, Frijlink HW. The choice of a compressor for the aerosolisation of tobramycin (TOBI-) with the PARI LC PLUS-reusable nebuliser. Int J Pharm 2003;268:59-69
41. Newman SP, Pellow PGD, Clarke SW. Droplet size distributions of nebulised aerosols for inhalation therapy. Clin Phys Physiol Meas 1986;7:139-46
42. Brand P, Friemel I, Meyer T, et al. Total deposition of therapeutic particles during spontaneous and controlled inhalations. J Pharm Sci 2000;89:724-31
43. Le Brun PP, De Boer AH, Heijerman HG, et al. A review of the technical aspects of drug nebulization. Pharm World Sci 2000;22:75-81
44. Vecellio L, Abdelrahim ME, Montharu J, et al. Disposable versus reusable jet nebulizers for cystic fibrosis treatment with tobramycin. J Cyst Fibros 2011;10:86-92
45. Khatri L, Taylor KM, Craig DQ, et al. An assessment of jet and ultrasonic nebulisers for the delivery of lactate dehydrogenase solutions. Int J Pharm 2001;227:121-31
46. WHO recommendations for routine immunization - summary tables. World Health Organization. Geneva, Switzerland. Available from: Http://www. who.int/immunization/policy/immunization-tables/en/index.html [Last accessed 21 April 2013]
47. Marguet C, Couderc L, Le Roux P, et al. Inhalation treatment: Errors in application and difficulties in acceptance of the devices are frequent in wheezy infants and young children. Pediatr Allergy Immunol 2001;12:224-30
48. Janssens HM, Heijnen EM, De Jong VM, et al. Aerosol delivery from spacers in wheezy infants: A daily life study. Eur Respir J 2000;16:850-6
49. Amorij J-P, Huckriede A, Wilschut J, et al. Development of stable influenza vaccine powder formulations: Challenges and possibilities. Pharm Res 2008;25:1256-73
50. Sou T, Meeusen EN, De Veer M, et al. New developments in dry powder pulmonary vaccine delivery. Trends Biotechnol 2011;29:191-8
51. Garcia-Contreras L, Wong Y-L, Muttil P, et al. Immunization by a bacterial aerosol. Proc Natl Acad Sci USA 2008;105:4656-60
52. Jin TH, Tsao E, Goudsmit J, et al. Stabilizing formulations for inhalable powders of an adenovirus 35-vectored tuberculosis (TB) vaccine (AERAS-402). Vaccine 2010;28:4369-75
53. Burger JL, Cape SP, Braun CS, et al. Stabilizing formulations for inhalable powders of live-attenuated measles virus vaccine. J Aerosol Med Pulm Deliv 2008;21:25-34
54. Amidi M, Pellikaan HC, Hirschberg H, et al. Diphtheria toxoid-containing microparticulate powder formulations for pulmonary vaccination: Preparation, characterization and evaluation in guinea pigs. Vaccine 2007;25:6818-29
55. Personal communication Dr. R.E. Sievers 56. Huang J, Garmise RJ, Crowder TM, et al. A novel dry powder influenza vaccine and intranasal delivery technology: Induction of systemic and mucosal immune responses in rats. Vaccine 2004;23:794-801
56. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 2000;203:1-60
57. Maa Y-F, Nguyen P-A, Sweeney T, et al. Protein inhalation powders: Spray drying vs spray freeze drying. Pharm Res 1999;16:249-54
58. Maa Y-F, Ameri M, Shu C, et al. Hepatitis-B surface antigen (HBsAg) powder formulation: Process and stability assessment. Curr Drug Deliv 2007;4:57-67
59. Chang L, Pikal M. Mechanisms of protein stabilization in the solid state. J Pharm Sci 2009;98:2886-908
60. Chang LL, Shepherd D, Sun J, et al. Mechanism of protein stabilization by sugars during freeze-drying and storage: Native structure preservation, specific interaction, and/or immobilization in a glassy matrix? J Pharm Sci 2005;94:1427-44
61. Gordon SB, Malamba R, Mthunthama N, et al. Inhaled delivery of 23-valent pneumococcal polysaccharide vaccine does not result in enhanced pulmonary mucosal immunoglobulin responses. Vaccine 2008;26:5400-6
62. Rosenthal S, McEnery J, Raisys N. Aerogenic BCG vaccination against tuberculosis in animal and human subjects. J Asthma 1968;5:309-23
63. Preparations for inhalation (0671). In: European Pharmacopoeia, 6th edition. Council of Europe, Strasbourg; 2008;p. 740-2
64. Mann J, Howarth P, Holgate S. Bronchoconstriction induced by ipratropium bromide in asthma: Relation to hypotonicity. Br Med J 1984;289:833
65. Schoeffel R, Anderson S, Altounyan R. Bronchial hyperreactivity in response to inhalation of ultrasonically nebulised solutions of distilled water and saline. Br Med J 1981;283:1285-7
66. Arakawa T, Timasheff SN. The stabilization of proteins by osmolytes. Biophys J 1985;47:411-14
67. Chi EY, Krishnan S, Randolph TW, et al. Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharm Res 2003;20:1325-36
68. Griffiths GD, Bailey SC, Hambrook JL, et al. Liposomally-encapsulated ricin toxoid vaccine delivered intratracheally elicits a good immune response and protects against a lethal pulmonary dose of ricin toxin. Vaccine 1997;15:1933-9
69. Griffiths GD, Phillips GJ, Bailey SC. Comparison of the quality of protection elicited by toxoid and peptide liposomal vaccine formulations against ricin as assessed by markers of inflammation. Vaccine 1999;17:2562-8
70. Kunda NK, Somavarapu S, Gordon SB, et al. Nanocarriers targeting dendritic cells for pulmonary vaccine delivery. Pharm Res 2012;30:325-41
71. Ballester M, Nembrini C, Dhar N, et al. Nanoparticle conjugation and pulmonary delivery enhance the protective efficacy of Ag85B and CpG against tuberculosis. Vaccine 2011;29:6959-66
72. Thomas C, Rawat A, Hope-Weeks L, et al. Aerosolized PLA and PLGA nanoparticles enhance humoral, mucosal and cytokine responses to hepatitis B vaccine. Mol Pharm 2011;8:405-15
73. Thomas C, Gupta V, Ahsan F. Influence of surface charge of PLGA particles of recombinant hepatitis B surface antigen in enhancing systemic and mucosal immune responses. Int J Pharm 2009;379:41-50
74. Thomas C, Gupta V, Ahsan F. Particle size influences the immune response produced by hepatitis B vaccine formulated in inhalable particles. Pharm Res 2010;27:905-19
75. Lu D, Garcia-Contreras L, Muttil P, et al. Pulmonary immunization using antigen 85-B polymeric microparticles to boost tuberculosis immunity. AAPS J 2010;12:338-47
76. Do Y, Didierlaurent AM, Ryu S, et al. Induction of pulmonary mucosal immune responses with a protein vaccine targeted to the DEC-205/CD205 receptor. Vaccine 2012;30:6359-67
77. Wolfe RM. Update on adult immunizations. J Am Board Fam Med 2012;25:496-510
78. Bader MS. Immunization for the elderly. Am J Med Sci 2007;334:481-6
79. Sievers RE, Cape SP, Mcadams DH, et al. Optimizing the effectiveness of live-attenuated measles vaccine aerosols/: Effects of different delivery modes. RDD Conference Proceedings 2012. 1-10
80. Muttil P, Pulliam B, Garcia-Contreras L, et al. Pulmonary immunization of guinea pigs with diphtheria CRM-197 antigen as nanoparticle aggregate dry powders enhance local and systemic immune responses. AAPS J 2010;12:699-707
81. Vujanic A, Wee JLK, Snibson KJ, et al. Combined mucosal and systemic immunity following pulmonary delivery of ISCOMATRIX adjuvanted recombinant antigens. Vaccine 2010;28:2593-7
82. Muttil P, Prego C, Garcia-Contreras L, et al. Immunization of guinea pigs with novel hepatitis B antigen as nanoparticle aggregate powders administered by the pulmonary route. AAPS J 2010;12:330-7
83. Minne A, Louahed J, Mehauden S, et al. The delivery site of a monovalent influenza vaccine within the respiratory tract impacts on the immune response. Immunology 2007;122:316-25
84. Amorij J-P, Saluja V, Petersen H, et al. Pulmonary delivery of an inulin-stabilized influenza subunit vaccine prepared by spray-freeze drying induces systemic, mucosal humoral as well as cell-mediated immune responses in BALB/c mice. Vaccine 2007;25:8707-17
85. Wee JLK, Scheerlinck J-PY, Snibson KJ, et al. Pulmonary delivery of ISCOMATRIX influenza vaccine induces both systemic and mucosal immunity with antigen dose sparing. Mucosal Immunol 2008;1:489-96
86. De Swart RL, Kuiken T, Fernandez-de Castro J, et al. Aerosol measles vaccination in macaques: Preclinical studies of immune responses and safety. Vaccine 2006;24:6424-36
87. De Swart RL, LiCalsi C, Quirk AV, et al. Measles vaccination of macaques by dry powder inhalation. Vaccine 2007;25:1183-90
88. Kisich KO, Higgins MP, Park I, et al. Dry powder measles vaccine: Particle deposition, virus replication, and immune response in cotton rats following inhalation. Vaccine 2011;29:905-12
89. Lin W-H, Griffin DE, Rota PA, et al. Successful respiratory immunization with dry powder live-attenuated measles virus vaccine in rhesus macaques. Proc Natl Acad Sci USA 2011;108:2987-92
90. White AD, Sibley L, Dennis MJ, et al. Evaluation of the safety and immunogenicity of a candidate tuberculosis vaccine, MVA85A, delivered by aerosol to the lungs of macaques. Clin Vaccine Immunol 2013;20:663-72
91. Todoroff J, Lemaire MM, Fillee C, et al. Mucosal and systemic immune responses to mycobacterium tuberculosis antigen 85A following its co-delivery with CpG, MPLA or LTB to the lungs in mice. PLoS One 2013;8:e63344
92. Lowell GH, Colleton C, Frost D, et al. Immunogenicity and efficacy against lethal aerosol staphylococcal enterotoxin B challenge in monkeys by intramuscular and respiratory delivery of proteosome-toxoid vaccines. Infect Immun 1996;64:4686-93
93. Greenway TE, Eldridge JH, Ludwig G, et al. Induction of protective immune responses against Venezuelan equine encephalitis (VEE) virus aerosol challenge with microencapsulated VEE virus vaccine. Vaccine 1998;16:1314-23
94. Eyles JE, Williamson ED, Spiers ID, et al. Protection studies following bronchopulmonary and intramuscular immunisation with yersinia pestis F1 and V subunit vaccines coencapsulated in biodegradable microspheres: A comparison of efficacy. Vaccine 2000;18:3266-71