Next generation vaccines: Single-dose encapsulated vaccines for improved global immunisation coverage and efficacy

Journal of Pharmacy and Pharmacology

Volumn 67, Issue 3, 2015, Pages 400-408

  Walters, Adam A ^a   Krastev, Christos ^a   Hill, Adrian V S ^a   Milicic, Anita ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Controlled release; microparticles

Indexed keywords

ANTIGEN; BACTERIAL VACCINE; POLYMER; VIRUS VACCINE; BIOMATERIAL; DELAYED RELEASE FORMULATION; VACCINE;

BACTERIAL INFECTION; BIOCOMPATIBILITY; DRUG CAPSULE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; DRUG STABILITY; ENCAPSULATION; FEASIBILITY STUDY; HEALTH CARE QUALITY; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; INFECTION PREVENTION; MEDICAL TECHNOLOGY; NONHUMAN; PARTICLE SIZE; PHYSICAL CHEMISTRY; PREVENTIVE HEALTH SERVICE; RETREATMENT; REVIEW; SINGLE DRUG DOSE; VACCINE PRODUCTION; VIRUS INFECTION; ANIMAL; DELAYED RELEASE FORMULATION; PROCEDURES; VACCINATION;

ANIMALS; BIOCOMPATIBLE MATERIALS; DELAYED-ACTION PREPARATIONS; DRUG COMPOUNDING; HUMANS; VACCINATION; VACCINES;

EID: 84925753094     PISSN: 00223573     EISSN: 20427158     Source Type: Journal    
DOI: 10.1111/jphp.12367     Document Type: Review

References (92)

1. Okwo-Bele JM, Cherian T,. The expanded programme on immunization: a lasting legacy of smallpox eradication. Vaccine 2011; 29 (Suppl. 4): D74-D79.
2. Roush SW, et al. Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 2007; 298: 2155-2163.
3. Guerin N, Roure C,. Immunisation schedules in the countries of the European Union. Euro Surveill 1995; 0: 5-7.
4. Muscat M, et al. The state of measles and rubella in the WHO European Region, 2013. Clin Microbiol Infect 2014; Suppl 5: 12-18.
5. Gust DA, et al. Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics 2008; 122: 718-725.
6. Falagas ME, Zarkadoulia E,. Factors associated with suboptimal compliance to vaccinations in children in developed countries: a systematic review. Curr Med Res Opin 2008; 24: 1719-1741.
7. Arevshatian L, et al. An evaluation of infant immunization in Africa: is a transformation in progress? Bull World Health Organ 2007; 85: 449-457.
8. Mutua MK, et al. Childhood vaccination in informal urban settlements in Nairobi, Kenya: who gets vaccinated? BMC Public Health 2011; 11: 6.
9. Favin M, et al. Why children are not vaccinated: a review of the grey literature. Int Health 2012; 4: 229-238.
10. Thakker Y, Woods S,. Storage of vaccines in the community: weak link in the cold chain? BMJ 1992; 304: 756-758.
11. Gupta RK, et al. Poly(lactide-co-glycolide) microparticles for the development of single-dose controlled-release vaccines. Adv Drug Deliv Rev 1998; 32: 225-246.
12. Freeman P, Robbins A,. Introduction: vaccine technologies and public health. Why a critical review now? Int J Technol Assess Health Care 1994; 10: 1-6.
13. Aguado MT, Lambert PH,. Controlled-release vaccines-biodegradable polylactide/polyglycolide (PL/PG) microspheres as antigen vehicles. Immunobiology 1992; 184: 113-125.
14. Bloom BR,. Vaccines for the Third World. Nature 1989; 342: 115-120.
15. Aguado MT,. Future approaches to vaccine development: single-dose vaccines using controlled-release delivery systems. Vaccine 1993; 11: 596-597.
16. Cohen S, et al. Novel approaches to controlled-release antigen delivery. Int J Technol Assess Health Care 1994; 10: 121-130.
17. Langer R,. New methods of drug delivery. Science 1990; 249: 1527-1533.
18. Machluf M, et al. Controlled release of therapeutic agents: slow delivery and cell encapsulation. World J Urol 2000; 18: 80-83.
19. Okada H, et al. Preparation of three-month depot injectable microspheres of leuprorelin acetate using biodegradable polymers. Pharm Res 1994; 11: 1143-1147.
20. Okada H,. One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv Drug Deliv Rev 1997; 28: 43-70.
21. Men Y, et al. A single administration of tetanus toxoid in biodegradable microspheres elicits T cell and antibody responses similar or superior to those obtained with aluminum hydroxide. Vaccine 1995; 13: 683-689.
22. Johansen P, et al. Ambiguities in the preclinical quality assessment of microparticulate vaccines. Trends Biotechnol 2000; 18: 203-211.
23. Johansen P, et al. Towards clinical testing of a single-administration tetanus vaccine based on PLA/PLGA microspheres. Vaccine 2000; 19: 1047-1054.
24. Kang F, Singh J,. Conformational stability of a model protein (bovine serum albumin) during primary emulsification process of PLGA microspheres synthesis. Int J Pharm 2003; 260: 149-156.
25. Xie S, et al. The effect of glycolic acid monomer ratio on the emulsifying activity of PLGA in preparation of protein-loaded SLN. Colloids Surf B Biointerfaces 2009; 74: 358-361.
26. Song X, et al. Dual agents loaded PLGA nanoparticles: systematic study of particle size and drug entrapment efficiency. Eur J Pharm Biopharm 2008; 69: 445-453.
27. Jain S, et al. The long-term potential of biodegradable poly(lactide-co-glycolide) microparticles as the next-generation vaccine adjuvant. Expert Rev Vaccines 2011; 10: 1731-1742.
28. van de Weert M, et al. Protein instability in poly(lactic-co-glycolic acid) microparticles. Pharm Res 2000; 17: 1159-1167.
29. Kersten GF, et al. Single shot with tetanus toxoid in biodegradable microspheres protects mice despite acid-induced denaturation of the antigen. Vaccine 1996; 14: 1627-1632.
30. Chang CP, et al. Release properties on gelatin-gum arabic microcapsules containing camphor oil with added polystyrene. Colloids Surf B Biointerfaces 2006; 50: 136-140.
31. Sanchez A, et al. Formulation strategies for the stabilization of tetanus toxoid in poly(lactide-co-glycolide) microspheres. Int J Pharm 1999; 185: 255-266.
32. Jiang W, Schwendeman SP,. Stabilization of tetanus toxoid encapsulated in PLGA microspheres. Mol Pharm 2008; 5: 808-817.
33. O'Hagan DT, et al. Biodegradable microparticles as controlled release antigen delivery systems. Immunology 1991; 73: 239-242.
34. Sinha VR, Trehan A,. Biodegradable microspheres for protein delivery. J Control Release 2003; 90: 261-280.
35. Lee HJ, et al. In vivo characterization of sustained-release formulations of human growth hormone. J Pharmacol Exp Ther 1997; 281: 1431-1439.
36. Visscher GE, et al. Tissue response to biodegradable injectable microcapsules. J Biomater Appl 1987; 2: 118-131.
37. Alonso MJ, et al. Determinants of release rate of tetanus vaccine from polyester microspheres. Pharm Res 1993; 10: 945-953.
38. Woodruff MA, Hutmacher DW,. The return of a forgotten polymer-polycaprolactone in the 21st century. Prog Polym Sci 2010; 35: 1217-1256.
39. Jain RA, et al. Controlled delivery of drugs from a novel injectable in situ formed biodegradable PLGA microsphere system. J Microencapsul 2000; 17: 343-362.
40. Chang MW, et al. A new method for the preparation of monoporous hollow microspheres. Langmuir 2010; 26: 5115-5121.
41. Allison SD,. Analysis of initial burst in PLGA microparticles. Expert Opin Drug Deliv 2008; 5: 615-628.
42. Cleland JL,. Single-administration vaccines: controlled-release technology to mimic repeated immunizations. Trends Biotechnol 1999; 17: 25-29.
43. Cleland JL, et al. Development of a single-shot subunit vaccine for HIV-1: part 4. Optimizing microencapsulation and pulsatile release of MN rgp120 from biodegradable microspheres. J Control Release 1997; 47: 135-150.
44. Alonso MJ, et al. Biodegradable microspheres as controlled-release tetanus toxoid delivery systems. Vaccine 1994; 12: 299-306.
45. Makadia HK, Siegel SJ,. Poly lactic-co-glycolic acid (PLGA) as biodegradable controlled drug delivery carrier. Polymers (Basel) 2011; 3: 1377-1397.
46. Vogelhuber W, et al. Programmable biodegradable implants. J Control Release 2001; 73: 75-88.
47. Cardamone M, et al. In vitro testing of a pulsatile delivery system and its in vivo application for immunisation against tetanus toxoid. J Control Release 1997; 47: 205-219.
48. Bhatnagar A, Sillanpaa M,. Applications of chitin- and chitosan-derivatives for the detoxification of water and wastewater-a short review. Adv Colloid Interface Sci 2009; 152: 26-38.
49. Slutter B, Jiskoot W,. Dual role of CpG as immune modulator and physical crosslinker in ovalbumin loaded N-trimethyl chitosan (TMC) nanoparticles for nasal vaccination. J Control Release 2010; 148: 117-121.
50. Sogias IA, et al. Why is chitosan mucoadhesive? Biomacromolecules 2008; 9: 1837-1842.
51. Smith J, et al. Effect of chitosan on epithelial cell tight junctions. Pharm Res 2004; 21: 43-49.
52. Lugade AA, et al. Single low-dose un-adjuvanted HBsAg nanoparticle vaccine elicits robust, durable immunity. Nanomedicine 2013; 9: 923-934.
53. Hu B, et al. Preparation and properties of polycarbonate microspheres containing tetanus toxoid vaccine. J Appl Polym Sci 2014; 131: 40048.
54. Huntimer L, et al. Evaluation of biocompatibility and administration site reactogenicity of polyanhydride-particle-based platform for vaccine delivery. Adv Healthc Mater 2013; 2: 369-378.
55. O'Hagan DT, Singh M,. Microparticles as vaccine adjuvants and delivery systems. Expert Rev Vaccines 2003; 2: 269-283.
56. Boehm G, et al. On technological and immunological benefits of multivalent single-injection microsphere vaccines. Pharm Res 2002; 19: 1330-1336.
57. Elamanchili P, et al. Characterization of poly(D,L-lactic-co-glycolic acid) based nanoparticulate system for enhanced delivery of antigens to dendritic cells. Vaccine 2004; 22: 2406-2412.
58. Xiang SD, et al. Pathogen recognition and development of particulate vaccines: does size matter? Methods 2006; 40: 1-9.
59. Champion JA, et al. Role of particle size in phagocytosis of polymeric microspheres. Pharm Res 2008; 25: 1815-1821.
60. Hirota K, et al. Optimum conditions for efficient phagocytosis of rifampicin-loaded PLGA microspheres by alveolar macrophages. J Control Release 2007; 119: 69-76.
61. Eldridge JH, et al. Biodegradable and biocompatible poly(DL-lactide-co-glycolide) microspheres as an adjuvant for staphylococcal enterotoxin B toxoid which enhances the level of toxin-neutralizing antibodies. Infect Immun 1991; 59: 2978-2986.
62. Singh M, et al. Controlled release microparticles as a single dose hepatitis B vaccine: evaluation of immunogenicity in mice. Vaccine 1997; 15: 475-481.
63. Oyewumi MO, et al. Nano-microparticles as immune adjuvants: correlating particle sizes and the resultant immune responses. Expert Rev Vaccines 2010; 9: 1095-1107.
64. Schliehe C, et al. CD8- dendritic cells and macrophages cross-present poly(D,L-lactate-co-glycolate) acid microsphere-encapsulated antigen in vivo. J Immunol 2011; 187: 2112-2121.
65. Shen H, et al. Enhanced and prolonged cross-presentation following endosomal escape of exogenous antigens encapsulated in biodegradable nanoparticles. Immunology 2006; 117: 78-88.
66. Tran KK, Shen H,. The role of phagosomal pH on the size-dependent efficiency of cross-presentation by dendritic cells. Biomaterials 2009; 30: 1356-1362.
67. Panyam J, et al. Rapid endo-lysosomal escape of poly(DL-lactide-co-glycolide) nanoparticles: implications for drug and gene delivery. FASEB J 2002; 16: 1217-1226.
68. Rock KL, Shen L,. Cross-presentation: underlying mechanisms and role in immune surveillance. Immunol Rev 2005; 207: 166-183.
69. Gerelchuluun T, et al. Dendritic cells process antigens encapsulated in a biodegradable polymer, poly(D,L-lactide-co-glycolide), via an alternate class I MHC processing pathway. Arch Pharm Res 2007; 30: 1440-1446.
70. Sharp FA, et al. Uptake of particulate vaccine adjuvants by dendritic cells activates the NALP3 inflammasome. Proc Natl Acad Sci U S A 2009; 106: 870-875.
71. Yazdi AS, et al. Nanoparticles activate the NLR pyrin domain containing 3 (Nlrp3) inflammasome and cause pulmonary inflammation through release of IL-1 alpha and IL-1 beta. Proc Natl Acad Sci U S A 2010; 107: 19449-19454.
72. Obst R, et al. Sustained antigen presentation can promote an immunogenic T cell response, like dendritic cell activation. Proc Natl Acad Sci U S A 2007; 104: 15460-15465.
73. Demento SL, et al. Role of sustained antigen release from nanoparticle vaccines in shaping the T cell memory phenotype. Biomaterials 2012; 33: 4957-4964.
74. Feng L, et al. Pharmaceutical and immunological evaluation of a single-dose hepatitis B vaccine using PLGA microspheres. J Control Release 2006; 112: 35-42.
75. Singh M, et al. Controlled release microparticles as a single dose diphtheria toxoid vaccine: immunogenicity in small animal models. Vaccine 1998; 16: 346-352.
76. Kanchan V, et al. Memory antibody response from antigen loaded polymer particles and the effect of antigen release kinetics. Biomaterials 2009; 30: 4763-4776.
77. Manolova V, et al. Nanoparticles target distinct dendritic cell populations according to their size. Eur J Immunol 2008; 38: 1404-1413.
78. Panos I, et al. New drug delivery systems based on chitosan. Curr Drug Discov Technol 2008; 5: 333-341.
79. Dang Y, et al. The effects of chitosan oligosaccharide on the activation of murine spleen CD11c+ dendritic cells via Toll-like receptor 4. Carbohydr Poly 2011; 83: 1075-1081.
80. Cleland JL, et al. Development of a single-shot subunit vaccine for HIV-1. 3. Effect of adjuvant and immunization schedule on the duration of the humoral immune response to recombinant MN gp120. J Pharm Sci 1996; 85: 1350-1357.
81. Cleland JL, et al. Development of a single-shot subunit vaccine for HIV-1. 5. programmable in vivo autoboost and long lasting neutralizing response. J Pharm Sci 1998; 87: 1489-1495.
82. Thomasin C, et al. Tetanus toxoid and synthetic malaria antigen containing poly(lactide)/poly(lactide-co-glycolide) microspheres: importance of polymer degradation and antigen release for immune response. J Control Release 1996; 41: 131-145.
83. Raghuvanshi RS, et al. Correlation between in vitro release and in vivo immune response from biodegradable polymer particles entrapping tetanus toxoid. Drug Deliv 2002; 9: 113-120.
84. Sanchez A, et al. Pulsed controlled-released system for potential use in vaccine delivery. J Pharm Sci 1996; 85: 547-552.
85. Dhiman N, Khuller GK,. Protective efficacy of mycobacterial 71-kDa cell wall associated protein using poly (DL-lactide-co-glycolide) microparticles as carrier vehicles. FEMS Immunol Med Microbiol 1998; 21: 19-28.
86. Katare YK, et al. Potentiation of immune response from polymer-entrapped antigen: toward development of single dose tetanus toxoid vaccine. Drug Deliv 2003; 10: 231-238.
87. Asano M, et al. Biodegradable poly (DL-lactic acid) formulations in a calcitonin delivery system. Biomaterials 1993; 14: 797-799.
88. Lee TH, et al. Double-walled microspheres for the sustained release of a highly water soluble drug: characterization and irradiation studies. J Control Release 2002; 83: 437-452.
89. Zheng W,. A water-in-oil-in-oil-in-water (W/O/O/W) method for producing drug-releasing, double-walled microspheres. Int J Pharm 2009; 374: 90-95.
90. Xu Q, et al. Monodisperse double-walled microspheres loaded with chitosan-p53 nanoparticles and doxorubicin for combined gene therapy and chemotherapy. J Control Release 2012; 163: 130-135.
91. Mao S, et al. Effect of WOW process parameters on morphology and burst release of FITC-dextran loaded PLGA microspheres. Int J Pharm 2007; 334: 137-148.
92. Sansdrap P, Moes AJ,. Influence of additives on the release profile of nifedipine from poly(DL-lactide-co-glycolide) microspheres. J Microencapsul 1998; 15: 545-553.