New advances in microsphere-based single-dose vaccines

Advanced Drug Delivery Reviews

Volumn 28, Issue 1, 1997, Pages 97-119

  Hanes, Justin ^a   Cleland, Jeffrey L ^b   Langer, Robert ^c  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b GENENTECH INC   (United States)

^c Massachusetts Institute of Technology Cambridge   (United States)

Author keywords

Antigen delivery; Antigen stability; Biodegradable microspheres; Controlled release; Immunization; Microsphere preparation; Mucosal immunization; Vaccine adjuvants; Vaccine delivery

Indexed keywords

ANTIGENS; BIODEGRADATION; ENCAPSULATION; IMMUNIZATION; PHARMACOKINETICS; PROTEINS; VACCINES;

ANTIGEN STABILITY; MICROSPHERES; PEPTIDES;

CONTROLLED DRUG DELIVERY;

ANTIGEN; CARMUSTINE; CYTOKINE; EXCIPIENT; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; IMINO ACID; IMMUNOLOGICAL ADJUVANT; INSULIN; LEUPRORELIN; LIPOSOME; MICROSPHERE; POLYANHYDRIDE; POLYGLACTIN; POLYMER; QS 21; SOLVENT; SURFACTANT; TUMOR VACCINE; TYROSINE DERIVATIVE; VACCINE;

ANIMAL MODEL; CANCER IMMUNOTHERAPY; CONTROLLED RELEASE FORMULATION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG IMPLANT; DRUG MANUFACTURE; DRUG POTENCY; DRUG RELEASE; DRUG STERILITY; HUMAN; IMMUNIZATION; INHALATIONAL DRUG ADMINISTRATION; INTRAMUSCULAR DRUG ADMINISTRATION; INTRANASAL DRUG ADMINISTRATION; INTRAPERITONEAL DRUG ADMINISTRATION; INTRATHECAL DRUG ADMINISTRATION; MICROENCAPSULATION; NONHUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; PROTEIN DEGRADATION; PROTEIN STABILITY; REVIEW; SUBCUTANEOUS DRUG ADMINISTRATION; VACCINE PRODUCTION;

EID: 0343632356     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0169-409X(97)00053-7     Document Type: Review

References (153)

1. M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995.
2. Glenny A.T., Pope C.G., Waddington H., Wallace U. The antigenic value of toxoid precipitated by potassium alum. J. Pathol. Bacteriol. 29:1926;38-39.
3. Gupta R.K., Relyveld E.H., Lindblad E.B., Bizzini B., Ben-Efraim S., Gupta C.K. Adjuvants - a balance between toxicity and adjuvanticity. Vaccine. 11:1993;293-306.
4. Aguado M.T. Future approaches to vaccine development: Single-dose vaccines using controlled-release delivery systems. Vaccine. 11:1993;596-597.
5. J. Hanes, M. Chiba, R. Langer, Polymer microspheres for vaccine delivery, in: M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995, 389-412.
6. Zell E.R., Dietz V., Stevenson J., Cochi S., Bruce R. Low vaccination levels of US preschool and school-age children: Retrospective assessments of vaccination coverage, 1991-1992. JAMA. 271:1994;833-839.
7. Goldstein K.P., Kviz F.J., Daum R.S. Accuracy of immunization histories provided by adults accompanying preschool children to a pediatric emergency department. JAMA. 270:1993;2190-2194.
8. Rappuoli R., Podda A., Giovannoni F., Nencioni L., Peragallo M., Francolini P. Absence of protective immunity against diphtheria in a large proportion of young adults. Vaccine. 11:1993;576-577.
9. National Vaccine Advisory Committee The measles epidemic: The problems, barriers, and recommendations. JAMA. 266:1991;1547-1552.
10. Arya S.C. Human immunization in developing countries: Practical and theoretical problems and prospects. Vaccine. 12:1994;1423-1435.
11. Bloom B.R. Vaccines for the Third World. Nature. 342:1989;115-120.
12. G. Ott, G. Van Nest, R.L. Burke, The use of muramyl peptides as vaccine adjuvants, in: W.C. Koff, H.R. Six (Eds.), Vaccine Research and Developments, Marcel Dekker, New York, 1992, pp. 89-114.
13. Edelman R. Vaccine adjuvants. Rev. Infect. Dis. 2:1980;370-383.
14. F.R. Vogel, M.F. Powell, A compendium of vaccine adjuvants and excipients, in: M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995, pp. 141-228.
15. Stevens V.C. Vaccine delivery systems: Potential methods for use in antifertility vaccines. Am. J. Reprod. Immunol. 29:1993;176-188.
16. D. Kline, J. Hanes, R. Langer, Adjuvant-active polymeric microparticulate vaccine-delivery systems, in: S. Cohen, H. Bernstein (Eds.), Microparticulate Systems for the Delivery of Proteins and Vaccines, Marcel Dekker, New York, 1996, pp. 349-379.
17. Preis I., Langer R. A single-step immunization by sustained antigen release. J. Immunol. Methods. 28:1979;193-197.
18. Tabata Y., Ikada Y. Macrophage phagocytosis of biodegradable microspheres composed of L-lactic/glycolic acid homo- and copolymers. J. Biomed. Mater. Res. 22:1988;837-858.
19. Men Y., Thomasin C., Merkle H.P., Gander B., Corradin G. 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. 13:1995;683-689.
20. + Th1 cells. Vaccine. 13:1995;1741-1749.
21. Nixon D.F., Hioe C., Chen P., Bian Z., Kuebler P., Li M.-L., Qiu H., Li X.-M., Singh M., Richardson J., McGee P., Zamb T., Koff W., Wang C.Y., O'Hagan D. Synthetic peptides entrapped in microparticles can elicit cytotoxic T cell activity. Vaccine. 14:1996;1523-1530.
22. Kovacsovics-Bandowski M., Clark K., Benacerraf B., Rock K.L. Efficient major histocompatibility complex class I presentation of exogenous antigen upon phagocytosis by macrophages. Proc. Natl. Acad. Sci. USA. 90:1993;4942-4946.
23. Falo L.D.J., Kovacsovics-Bankowski M., Thompson K., Rock K.L. Targeting antigen into the phagocytic pathway in vivo induces protective tumour immunity. Nature Medicine. 1:1995;649-653.
24. Rock K.L., Clark K. Analysis of the role of MHC class II presentation in the stimulation of cytotoxic T lymphocytes by antigens targeted into the exogenous antigen-MHC class I presentation pathway. J. Immunol. 156:1996;3721-3726.
25. Eldridge J.H., Meulbroek J.A., Staas J.K., Tice T.R., Gilley R.M. Vaccine-containing biodegradable microspheres specifically enter the gut-associated lymphoid tissue following oral administration and induce a disseminated mucosal immune response. Adv. Exp. Med. Biol. 251:1989;192-202.
26. Eldridge J.H., Hammond C.J., Meulbroek J.A. Controlled vaccine release in the gut-associated lymphoid tissues. I. Orally administered biodegradable microspheres target the Peyer's patches. J. Controlled Release. 11:1990;205-214.
27. M. Chasin, R. Langer (Eds.), Biodegradable Polymers as Drug Delivery Systems, Marcel Dekker, New York, 1990.
28. J.L. Cleland, R. Langer, Formulation and delivery of proteins and peptides: Design and development strategies, in: J.L. Cleland, R. Langer (Eds.), Formulation and Delivery of Proteins and Peptides, American Chemical Society, Washington, DC, 1994, pp. 1-21.
29. Austin P.E., Dunn K.A., Elly-Cofield K., Brown C.K., Wooden W.A., Bradfield J.F. Subcuticular sutures and the rate of inflammation in noncontaminated wounds. Ann. Emerg. Med. 25:1995;328-330.
30. Pihlajamaki H., Bostman O., Hirvensalo E., Tormala P., Rokkanen P. Absorbable pins of self-reinforced poly-L-lactic acid for fixation of fractures and osteotomes. J. Bone Joint Surg. 74:1992;853-857.
31. Winde G., Reers B., Nottberg H., Berns T., Meyer J., Bunte H. Clinical and functional results of abdominal rectopexy with absorbable mesh-graft for treatment of complete rectal prolapse. Eur. J. Surg. 159:1993;301-305.
32. Plosker G.L., Brogden R.N. Leuprorelin. A review of its pharmacology and therapeutical use in prostatic cancer, endometriosis and other sex hormone-related disorders. Drugs. 48:1994;930-967.
33. Brem H., Piantadosi S., Burger P.C., Walker M., Selker R., Vick N.A., Black K., Sisti M., Brem S., Mohr G., Muller P., Morawetz R., Schold S.C. Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. Lancet. 345:1995;1008-1012.
34. Tabata Y., Gutta S., Langer R. Controlled delivery systems for proteins using polyanhydride microspheres. Pharm. Res. 10:1993;487-496.
35. Ron E., Turek T., Mathiowitz E., Chasin M., Hageman M., Langer R. Controlled release of polypeptides from polyanhydrides. Proc. Natl. Acad. Sci. USA. 90:1993;4176-4180.
36. Shieh L., Tamada J., Tabata Y., Domb A., Langer R. Drug release from a new family of biodegradable polyanhydrides. J. Controlled Rel. 29:1994;73-82.
37. M. Chiba, J. Hanes, R. Langer, Polyanhydride microspheres as potential vaccine delivery systems, in: Proc. 21st Intern. Symp. Control. Rel. Bioact. Mater., Nice, France, 1994, Controlled Release Society, pp. 877-878.
38. J. Hanes, M. Chiba, R. Langer, Degradation of porous poly(anhydride-co-imide) microspheres and implications for macromolecule delivery, Biomaterials, in press.
39. J.L. Cleland, Design and production of single-immunization vaccines using polylactide polyglycolide microsphere systems, in: M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995, pp. 439-462.
40. D.H. Lewis, Controlled release of bioactive agents from lactide/glycolide polymers, in: M. Chasin, R. Langer (Eds.), Biodegradable Polymers as Drug Delivery Systems, Marcel Dekker, New York, 1990, pp. 1-41.
41. Cleland J.L., Lim A., Barrón L., Duenas E.T., Powell M.F. Development of a single-shot subunit vaccine for HIV-1: Part 4. Optimizing microencapsulation and pulsatile release of MN rgp120 from biodegradable microspheres. J. Controlled Rel. 47:1997;135-150.
42. Cohen S., Yoshioka T., Lucarelli M., Hwang L.H., Langer R. Controlled delivery systems for proteins based on poly(lactic/glycolic acid) microspheres. Pharm. Res. 8:1991;713-720.
43. J.L. Cleland, E.T. Duenas, A.L. Daugherty, M. Marian, J. Yang, M. Wilson, A.C. Celniker, A. Shahzamani, V. Quarmby, H. Chu, V. Mukku, A. Mac, M. Roussakis, N. Gillette, B. Boyd, D. Yeung, D. Brooks, Y.-F. Maa, C. Hsu, A.J.S. Jones, Recombinant human growth hormone poly(lactic-co-glycolic acid) (PLGA) microspheres provide a long lasting effect, J. Controlled Rel., in press.
44. J.L. Cleland, Protein delivery from biodegradable microspheres, in: L. Sanders, W. Hendren (Eds.), Protein Delivery: Physical Systems, Plenum Press, New York, 1997, pp. 1-43.
45. Tamada J., Langer R. The development of polyanhydrides for drug delivery applications. J. Biomater. Sci., Polym. Edn. 3:1992;315-353.
46. Lee H.J., Riley G., Johnson O.F., Cleland J.L., Kim N., Charnis M., Bailey L., Duenas E., Shahzamani A., Marian M., Jones A.J.S., Putney S.D. In vivo characterization of sustained release formulations of human growth hormone. J. Pharm. Exper. Ther. 281:1997;1-9.
47. Johnson O.L., Cleland J.L., Lee H.J., Charnis M., Duenas E., Jaworowicz W., Shepard D., Shahzamani A., Jones A.J.S., Putney S.D. A month-long effect from a single injection of microencapsulated human growth hormone. Nature Med. 2:1996;795-799.
48. Sah H., Chien Y. Degradability and antigen-release characteristics of polyester microspheres prepared from polymer blends. J. Appl. Polym. Sci. 58:1995;197-206.
49. Hora M.S., Rana R.K., Nunberg J.H., Tice T.R., Gilley R.M., Hudson M.E. Release of human serum albumin from poly(lactide-co-glycolide) microspheres. Pharm. Res. 7:1990;1190-1194.
50. R.P. Batycky, J. Hanes, R. Langer, D.A. Edwards, Theoretical model of erosion and macromolecule release from biodegrading microspheres, J. Pharm. Sci., in press.
51. T.H. Ferguson, Sterilization of controlled release systems, in: D. Hsieh (Ed.), Controlled Release Systems: Fabrication Technology, CRC Press, Boca Raton, 1988, pp. 163-178.
52. Birkinshaw C., Buggy M., Henn G.G., Jones E. Irradiation of poly(D,L-lactide). Polym. Degrad. Stab. 38:1992;249-253.
53. Horacek I., Kudlacek L. Influence of molecular weight on the resistance of polylactide fibers by radiation sterilization. J. Appl. Polym. Sci. 50:1993;1-5.
54. Hausberger A.G., Kenley R.A., DeLuca P.P. Gamma irradiation effects on molecular weight and in vitro degradation of poly(D,L-lactide-co-glycolide) microparticles. Pharm. Res. 12:1995;851-856.
55. Spenlehauer G., Vert M., Benoit J.P., Boddaert A. In vitro and in vivo degradation of poly(D,L-lactide/glycolide) type microspheres made by solvent evaporation method. Biomaterials. 10:1989;557-563.
56. S.R. Hartas, J.H. Collett, C. Booth, The influence of gamma-irradiation on the release of melatonin from poly(lactide-coglycolide) microspheres, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., Orlando, 1992, Vol. 19, pp. 321-322.
57. Volland C., Wolff M., Kissel T. The influence of terminal gamma-sterilization on captopril containing poly(D,L-lactide-co-glycolide) microspheres. J. Controlled Rel. 31:1994;293-305.
58. Haskill J.S., Hunt J.W. Radiation damage to crystalline ribonuclease: Identification of polypeptide chain breakage in the denatured and aggregated products. Radiation Resistance. 32:1967;827-848.
59. Haskill J.S., Hunt J.W. Radiation damage to crystalline ribonuclease: Importance of free radicals in the formation of denatured and aggregated products. Radiation Resistance. 32:1967;606-624.
60. Esparza I., Kissel T. Parameters affecting the immunogenicity of microencapsulated tetanus toxoid. Vaccine. 10:1992;714-720.
61. Cleland J., Powell M., Shire S. Development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation. CRC Crit. Rev. Ther. Drug Carrier Sys. 10:1993;307-377.
62. Manning M.C., Patel K., Borshardt R.T. Stability of protein pharmaceuticals. Pharm. Res. 6:1989;903-917.
63. Arakawa T., Prestrelski S.J., Kenney W.C., Carpenter J.F. Factors affecting short-term and long-term stabilities of proteins. Adv. Drug Del. Rev. 10:1993;1-28.
64. R. Pearlman, T.H. Nguyen, Analysis of Protein Drugs, in: V.H.L. Lee (Ed.), Peptide and Protein Drug Delivery, Marcel Dekker, New York, 1991, pp. 247-301.
65. D.B. Volkin, A.M. Klibanov, Minimizing protein inactivation, in: T.E. Creighton (Ed.), Protein Function: A Practical Approach, IRL Press, Oxford, 1989, pp. 1-24.
66. T. Imoto, H. Yamada, Chemical modification, in: T.E. Creighton (Ed.), Protein Function: A Practical Approach, IRL Press, Oxford, 1989, pp. 247-278.
67. Chang Y., Wang J., Hanson M.A. Parenteral formulations of proteins and peptides: Stability and stabilizers. J. Parenteral Sci. Tech. 42:1988;S3-S26.
68. A.J.S. Jones, Analytical methods for the assessment of protein formulations and delivery systems, in: J.L. Cleland, R. Langer (Eds.) Formulation and Delivery of Proteins and Peptides, American Chemical Society, Washington, DC, 1994, pp. 22-45.
69. M.J. Pikal, Freeze-drying of proteins: Process, formulation, and stability, in: J.L. Cleland, R. Langer (Eds.), Formulation and Delivery of Proteins and Peptides, American Chemical Society, Washington, DC, 1994, pp. 120-133.
70. J.F. Carpenter, S.J. Prestrelski, T.J. Anchordoguy, T. Arakawa, Interactions of stabilizers with proteins during freezing and drying, in: J.L. Cleland, R. Langer (Eds.), Formulation and Delivery of Proteins and Peptides, American Chemical Society, Washington, DC, 1994, pp. 134-147.
71. S.P. Schwendeman, M. Cardamone, A. Klibanov, R. Langer, Stability of proteins and their delivery from biodegradable polymer microspheres, in: S. Cohen, H. Bernstein (Eds.), Microparticulate Systems for the Delivery of Proteins and Vaccines, Marcel Dekker, New York, 1996, pp. 1-49.
72. Cleland J.L., Jones A.J.S. Stable formulations of recombinant human growth hormone and interferon-γ for microencapsulation in biodegradable polymers. Pharm. Res. 13:1996;1462-1473.
73. Chang A.C., Gupta R.K. Stabilization of tetanus toxoid in poly(D,L-lactic-co-glycolic acid) microspheres for the controlled release of antigen. J. Pharm. Sci. 85:1996;129-132.
74. Shah S.S., Cha Y., Pitt C.G. Poly(glycolic acid-co-D,L-lactic acid): Diffusion or degradation controlled drug delivery? J. Controlled Rel. 18:1992;261-270.
75. Cleland J.L., Mac A., Boyd B., Yang J., Duenas E.T., Yeung D., Brooks D., Hsu C., Chu H., Mukku V., Jones A.J.S. The stability of recombinant human growth hormone in poly(lactic-co-glycolic acid) PLGA microspheres. Pharm. Res. 14:1997;420-425.
76. Schwendeman S.P., Costantino H.R., Gupta R.K., Siber G.R., Klibanov A.M., Langer R. Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation. Proc. Natl. Acad. Sci. USA. 92:1995;11234-11238.
77. Singh M., Singh O., Talwar G.P. Biodegradable delivery system for a birth control vaccine: Immunogenicity studies in rats and monkeys. Pharm. Res. 12:1995;1796-1800.
78. Sah H., Toddywalla R., Chien Y.W. Continuous release of proteins from biodegradable microcapsules and in vivo evaluation of their potential as a vaccine adjuvant. J. Controlled Rel. 35:1995;137-144.
79. T. Kissel, R. Koneberg, Injectable biodegradable microspheres for vaccine delivery, in: S. Cohen, H. Bernstein (Eds.), Microparticulate Systems for the Delivery of Proteins and Vaccines, Marcel Dekker, New York, 1996, pp. 51-87.
80. Aguado M.T., Lambert P.-H. Controlled-release vaccines-biodegradable polylactide/polyglycolide (PL/PG) microspheres as antigen vehicles. Immunobiol. 184:1992;113-125.
81. Schwendeman S.P., Costantino H.R., Gupta R.K., Tobio M., Chang A.C., Alonso M.J., Siber G.R., Langer R. Strategies for stabilising tetanus toxoid towards the development of a single-dose tetanus vaccine. Dev. Biol. Stand. 87:1996;293-306.
82. Sanchez A., Gupta R.K., Alonso M.J., Siber G.R., Langer R. Pulsed controlled-release system for potential use in vaccine delivery. J. Pharm. Sci. 85:1996;547-552.
83. B. Gander, C. Thomasin, H.P. Merkle, Y. Men, G. Corradin, Pulsed tetanus toxoid release from PLGA-microspheres and its relevance for immunogenicity in mice, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., 1993, Controlled Release Society, Washington, DC, Vol. 20, pp. 65-66.
84. Alonso M.J., Cohen S., Park T.G., Gupta R.K., Siber G.R., Langer R. Determinants of release rate of tetanus vaccine from polyester microspheres. Pharm. Res. 10:1993;945-953.
85. Alonso M.J., Gupta R.K., Min C., Siber G.R., Langer R. Biodegradable microspheres as controlled release tetanus toxoid delivery systems. Vaccine. 12:1994;299-306.
86. Cleland J.L., Powell M.F., Lim A., Barrón L., Berman P.W., Eastman D.J., Nunberg J.H., Wrin T., Vennari J.C. Development of a single shot subunit vaccine for HIV-1. AIDS Res. Human Retrovirus. 10:1994;S21-S26.
87. Cleland J.L., Barron L., Berman P.W., Daugherty A., Gregory T., Lim A., Vennari J., Wrin T., Powell M.F. Development of a single-shot subunit vaccine for HIV-1: Part 2. Defining optimal autoboost characteristics to maximize the humoral immune response. J. Pharm. Sci. 85:1996;1346-1349.
88. Cleland J.L., Barron L., Daugherty A., Eastman D., Kensil C., Lim A., Weissburg R.P., Wrin T., Vennari J., Powell M.F. Development of a single-shot subunit vaccine for HIV-1: Part 3. Effect of adjuvant and immunization schedule on the duration of the humoral immune response to recombinant MN gp120. J. Pharm. Sci. 85:1996;1350-1357.
89. Cleland J.L., Powell M.F., Lim A., Barrón L., Berman P.W., Nunberg J.H., Eastman D.J., Wrin T., Vennari J.C., Murthy K.K., Kensil C.R., Wu J.Y. Development of a single administration subunit vaccine for HIV-1. in Proc. Intern. Symp. Control. Rel. Bioact. Mater. 22:1995;570-571.
90. Freund J. The effect of paraffin oil and mycobacteria on antibody formation and sensitization. Am. J. Clin. Pathol. 21:1951;645-656.
91. C.R. Kensil, J.-Y. Wu, S. Soltysik, Structural and immunological characterization of the vaccine adjuvant QS-21, in: M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995, pp. 525-542.
92. Cleland J.L., Kensil C.R., Lim A., Jacobsen N.E., Basa L., Spellman M., Wheeler D.A., Wu J.-Y., Powell M.F. The isomerization and formulation stability of the vaccine adjuvant QS-21. J. Pharm. Sci. 81:1996;22-28.
93. J. Hanes, Polymer microspheres for vaccine delivery. Ph.D. Thesis, Massachusetts Institute of Technology, 1996.
94. Kohn J., Niemi S.M., Albert E.C., Murphy J.C., Langer R., Fox J.G. Single-step immunization using a controlled release, biodegradable polymer with sustained adjuvant activity. J. Immunol. Methods. 95:1986;31-38.
95. Kohn J., Langer R. Polymerization reactions involving the side chains of α-L-amino acids. J. Am. Chem. Soc. 109:1987;817-820.
96. D.F. Kline, Tyrosine-based, adjuvant-active polyiminocarbonates and controlled release of antigen, Ph.D. Thesis, Massachusetts Institute of Technology, 1993.
97. Laurencin C., Domb A., Morris C., Brown V., Chasin M., McConnell R., Lange N., Langer R. Poly(anhydride) administration in high doses in vivo: Studies of biocompatibility and toxicology. J. Biomed. Mater. Res. 24:1990;1463-1481.
98. Leong K.W., Brott B.C., Langer R. Bioerodible polyanhydrides as drug-carrier matrices. I: Characterization, degradation, and release characteristics. J. Biomed. Mater. Res. 19:1985;941-955.
99. Hanes J., Chiba M., Langer R. Synthesis and characterization of degradable anhydride-co-imide terpolymers containing trimellitylimido-L-tyrosine: Novel polymers for drug delivery. Macromolecules. 29:1996;5279-5287.
100. J. Hanes, M. Chiba, R. Langer, Degradation and erosion of tyrosine-containing polyanhydrides: Implications for vaccine delivery, in: Proc. 21st Intern. Symp. Control. Rel. Bioact. Mater., 1994, Nice, France, Controlled Release Society, pp. 877-878.
101. Chiba M., Hanes J., Langer R. Controlled protein delivery from biodegradable tyrosine-containing poly(anhydride-co-imide) microspheres. Biomaterials. 18:1997;893-901.
102. Ada G. Strategies for exploiting the immune system in the design of vaccines. Mol. Immunol. 28:1991;225-230.
103. Khan M.Z.I., Opdebeeck J.P., Tucker I.G. Immunopotentiation and delivery systems for antigens for single-step immunization: Recent trends and progress. Pharm. Res. 11:1994;2-11.
104. Mao H.-Q., Zhuo R.-X., Fan C.-L. Synthesis and biological properties of polymer immunoadjuvants. Polymer Journal. 25:1993;499-505.
105. D.T. O'Hagan, Microparticles as oral vaccines, in: D.T. O'Hagan (Ed.), Novel Delivery Systems for Oral Vaccines, CRC Press, Boca Raton, 1994, pp. 175-205.
106. H.R. Bhagat, P.S. Dalal, Oral vaccination by microspheres, in: S. Cohen, H. Bernstein (Eds.), Microparticulate Systems for the Delivery of Proteins and Vaccines, Marcel Dekker, New York, 1996, pp. 381-399.
107. O'Hagan D.T. Intestinal translocation of particulates-implications for drug and antigen delivery. Adv. Drug Deliv. Rev. 5:1990;265-285.
108. O'Hagan D.T., McGee J.P., Holmgren J., Mowat A.M., Donachie A.M., Mills K.H.G., Gaisford W., Rahman D., Challacombe S.J. Biodegradable microparticles for oral immunization. Vaccine. 11:1993;149-154.
109. Eldridge J.H., Staas J.K., Meulbroek J.A., McGhee J.R., Tice T.R., Gilley R.M. Biodegradable microspheres as a vaccine delivery system. Mol. Immunol. 28:1991;287-294.
110. J.K. Staas, pers. comm., 1997.
111. Marx P., Compans R., Gettie A., Staas J., Gilley R., Mulligan M., Yamshchikov G., Chen D., Eldridge J. Protection against vaginal SIV transmission with microencapsulated vaccine. Science. 260:1993;1323-1327.
112. J.K. Staas, R.E. Hunt, P.A. Marx, R.W. Compans, J.F. Smith, J.H. Eldridge, J.W. Gibson, T.R. Tice, R.M. Gilley, Mucosal immunization using microsphere delivery systems, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., 1993, Controlled Release Society, Washington, DC, Vol. 20, pp. 63-64.
113. Tseng J., Komisar J.L., Trout R.N., Hunt R.E., Chen J.Y., Johnson A.J., Pitt L., Ruble D.L. Humoral immunity to aerosolized staphylococcal enterotoxin B (SEB), a superantigen, in monkeys vaccinated with SEB toxoid-containing microspheres. Infect. Immun. 63:1995;2880-2885.
114. J. Hanes, C.E. Evora, A. Ben-Jebria, D.A. Edwards, R. Langer, Porous dry-powder PLGA microspheres coated with lung surfactant for systemic insulin delivery via the lung, in: Proc. Inter. Symp. Control. Rel. Bioact. Mater., Stockholm, 1997, Controlled Release Society, Vol. 24, pp. 57-58.
115. Edwards D.A., Hanes J., Caponetti G., Hrkach J., Ben-Jebria A., Lotan N., Eskew M.L., Ultman J., Langer R. Large porous aerosols for pulmonary drug delivery. Science. 276:1997;1868-1871.
116. Colthorpe P., Farr S.J., Taylor G., Smith I.J., Wyatt D. The pharmacokinetics of pulmonary-delivered insulin: A comparison of intratracheal and aerosol administration to the rabbit. Pharm. Res. 9:1992;764-768.
117. Liu F., Shao Z., Kildsig D., Mitra A. Pulmonary delivery of free and liposomal insulin. Pharm. Res. 10:1993;228-232.
118. M.J. Newman, M.F. Powell, Immunological and formulation design considerations for subunit vaccines, in: M.F. Powell, M.J. Newman (Eds.), Vaccine Design: The Subunit and Adjuvant Approach, Plenum Press, New York, 1995, pp. 1-28.
119. Singh M., Li X.-M., McGee J.P., Zamb T., Koff W., Wang C.Y., O'Hagan D.T. Controlled release microparticles as a single dose hepatitis B vaccine: Evaluation of immunogenicity in mice. Vaccine. 15:1997;475-481.
120. Pardoll D.M. Paracrine cytokine adjuvants in cancer immunotherapy. Annu. Rev. Immunol. 13:1995;399-415.
121. Rosenberg S.A. Immunotherapy and gene therapy of cancer. Cancer Res. 51:1991;5074-5079.
122. Rosenberg S.A., Lotze M.T., Yang J.C., Aebersold P.A., Lineham W.M., Seipp C.A., White D.E. Experience with the use of high-dose interleukin-2 in the treatment of 652 patients with cancer. Ann. Surg. 210:1989;474-485.
123. Thompson R.C., Pardoll D.M., Jaffee E.M., Ewend M.G., Thomas M.C., Tyler B.M., Brem H. Systemic and local paracrine cytokine therapies using transduced tumor cells are synergistic in treating intracranial tumors. J. Immunother. 19:1997;405-413.
124. Staib L., Harel W., Mitchell M.S. Protection against experimental cerebral metastases of murine melanoma B16 by active immunization. Cancer Res. 53:1993;1113-1121.
125. Yu J.S., Wei M.X., Chiocca E.A., Martuza R.L., Tepper R.I. Treatment of glioma by engineered interleukin 4-secreting cells. Cancer Res. 53:1993;3125-3128.
126. Fearon E., Pardoll D., Itaya T., Golumbek P., Levitsky H., Simons J., Karasuyama H., Vogelstein B., Frost P. Interleukin-2 production by tumor cells bypasses T helper function in the generation of an antitumor response. Cell. 60:1990;397-403.
127. Gansbacher B., Zier K., Daniels B., Cronin K., Bannerji R., Gilboa E. Interleukin-2 gene transfer into tumor cells abrogates tumorigenicity and induces protective immunity. J. Exp. Med. 172:1990;1217-1224.
128. Tepper R., Pattengale P., Leder P. Murine interleukin-4 displays potent anti-tumor activity in vivo. Cell. 57:1989;503-512.
129. Golumbek P.T., Lazenby A.J., Levitsky H.I., Jaffee L.M., Karasuyama H., Baker M., Pardoll D.M. Treatment of established renal cancer by tumor cells engineered to secrete interleukin-4. Science. 254:1991;713-716.
130. Golumbek P.T., Azhari R., Jaffee E.M., Levitsky H.I., Lazenby A., Leong K., Pardoll D.M. Controlled release, biodegradable cytokine depots: A new approach in cancer vaccine design. Cancer Research. 53:1993;5841-5844.
131. A.K. Sills, Z. Zhao, K. van Wessem, J. Crongeyer, B. Tyler, M.G. Ewend, K. Leong, H. Brem, Intracranial delivery of interleukin-2 by microspheres in the treatment of brain tumors, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., Kyoto, Controlled Release Society, 1996, pp. 855-856.
132. Alving C.R. Delivery of liposome-encapsulated drugs to macrophages. Pharmacological Therapy. 22:1983;407-424.
133. Gregoriadis G. Immunological adjuvants: A role for liposomes. Immunol. Today. 11:1990;89-97.
134. Eppstein D.A., Marsh Y.V., van der Pas M.A., Felgner P.L., Schreiber A.B. Biological activity of liposome-encapsulated murine interferon gamma is mediated by a cell membrane receptor. Proc. Natl. Acad. Sci. USA. 82:1985;3688-3692.
135. Cohen S., Bernstein H., Hewes C., Chow M., Langer R. The pharmacokinetics of, and humoral responses to, antigen delivered by microencapsulated liposomes. Proc. Natl. Acad. Sci. USA. 88:1991;10440-10444.
136. J. Okada, Polymerized and microencapsulated liposomes for oral delivery and vaccination, in: S. Cohen, H. Bernstein (Eds.), Microparticulate Systems for the Delivery of Proteins and Vaccines, Marcel Dekker, New York, 1996, pp. 307-320.
137. Helliwell M. The use of bioadhesives in targeted delivery within the gastrointestinal tract. Adv. Drug Delivery Rev. 11:1993;221-251.
138. Gu J.M., Robinson J.R., Leung S.H. Binding of acrylic polymers to mucin/epithelial surfaces: Structure-property relationships. Crit. Rev. Ther. Drug Carrier Syst. 5:1988;21-67.
139. MacAdam A.B., Martin G.P., James S.L., Marriott C. Preparation and characterisation of anti-porcine gastric mucus antibodies. J. Pharm. Pharmacol. 43:1991;62P.
140. A.B. MacAdam, G.P. Martin, S.L. James, C. Marriott, Development of a novel delivery system for targeting the gastro-intestinal tract, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., Orlando, 1992, Controlled Release Society, Vol. 19, pp. 277-278.
141. Chen H., Torchilin V., Langer R. Lectin-bearing polymerized liposomes as potential oral vaccine carriers. Pharm. Res. 13:1996;1378-1383.
142. Neutra M.R., Kraehenbuhl J.-P. Transepithelial transport and mucosal defence. I: The role of M cells. Trends Cell Biol. 2:1992;134-138.
143. Sicinski P., Rowinski J., Warchol J.B., Jarzabek Z., Gut W., Szczygiel B., Bielecki K., Koch G. Poliovirus type 1 enters the human host through intestinal M cells. Gastroenterology. 98:1990;56-58.
144. Wassef J.S., Keren D.F., Mailloux J.L. Role of M cells in initial antigen uptake and in ulcer formation in the rabbit intestinal loop model of shigellosis. Infect. Immun. 57:1989;858-863.
145. Owel R.L., Pierce N.F., Apple R.T., Cray W.C.J. M cell transport of Vibrio cholerae from the intestinal lumen into Peyer's patches: A mechanism for antigen sampling and for microbial transepithelial migration. J. Infect. Dis. 153:1986;1108-1118.
146. Kohbata S., Yokobata H., Yabuuchi E. Cytopathogenic effect of Salmonella Typhi GIFU 10007 on M cells of murine ileal Peyer's patches in ligated ileal loops: An ultrastructural study. Microbiol. Immunol. 30:1986;1225-1237.
147. Inman L.R., Cantey J.R. Specific adherence of Escherichia Coli (strain RDEC-1) to membranous (M) cells of the Peyer's patch in Escherichia Coli diarrhea in the rabbit. J. Clin. Invest. 71:1983;1-8.
148. Wolf J.L., Kauffman R.S., Finberg R., Dambrauskas R., Fields B.N., Trier J.S. Determinants of Reovirus interaction with the intestinal M cells and absorptive cells of murine intestine. Gastroenterology. 85:1983;291-300.
149. E. Bjork, K. Holmberg, B. Bake, P. Edman, Effect of degradable starch microspheres on the human mucociliary clearance, in: Proc. Intern. Symp. Control. Rel. Bioact. Mater., Orlando, 1992, Controlled Release Society, Vol. 19, pp. 417-418.
150. O'Hagan D.T., Rafferty D., Wharton S., Illum L. Intravaginal immunization in sheep using a bioadhesive microsphere antigen delivery system. Vaccine. 11:1993;660-664.
151. Niemi S.M., Fox J.G., Brown L.R., Langer R. Evaluation of ethylene-vinyl acetate copolymer as a non-inflammatory alternative to Freund's complete adjuvant in rabbits. Laboratory Animal Science. 35:1985;609-612.
152. O'Hagan D.T., Rahman D., McGee J.P., Jeffery H., Davies M.C., Williams P., Davis S.S. Biodegradable microparticles as controlled release antigen delivery systems. Immunology. 73:1991;239-242.
153. Singh M., Singh A., Talwar G.P. Controlled delivery of diphtheria toxoid using biodegradable poly(D, L-lactide) microcapsules. Pharm. Res. 8:1991;958-961.