Novel biocompatible anionic polymeric microspheres for the delivery of the HIV-1 Tat protein for vaccine application

Vaccine

Volumn 22, Issue 21-22, 2004, Pages 2910-2924

  Caputo, Antonella ^a   Brocca Cofano, Egidio ^a   Castaldello, Arianna ^a   De Michele, Rita ^a   Altavilla, Giuseppe ^b   Marchisio, Marco ^a   Gavioli, Riccardo ^a   Rolen, Ulrika ^a   Chiarantini, Laura ^c   Cerasi, Aurora ^c   Dominici, Sabrina ^c   Magnani, Mauro ^c   Cafaro, Aurelio ^d   Sparnacci, Katia ^e   Laus, Michele ^e   Tondelli, Luisa ^f   Ensoli, Barbara ^d  

^a UNIVERSITY OF FERRARA   (Italy)

^b UNIVERSITY OF PADOVA   (Italy)

^c UNIVERSITY OF URBINO   (Italy)

^d ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^e UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^f CNR   (Italy)

Author keywords

Biocompatible microspheres; HIV 1 Tat protein; Vaccine

Indexed keywords

EUDRAGIT; FREUND ADJUVANT; MICROSPHERE; POLY(METHYL METHACRYLATE); POLYMER; POLYSTYRENE; POLYVINYL ALCOHOL; TRANSACTIVATOR PROTEIN; VACCINE; VIRUS PROTEIN;

ADSORPTION; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BIOCOMPATIBILITY; CHEMICAL COMPOSITION; CONTROLLED STUDY; DISPERSION; DRUG DELIVERY SYSTEM; EXPERIMENTAL MOUSE; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1; IN VITRO STUDY; INTRACELLULAR SPACE; MOLECULAR SIZE; MOUSE; NONHUMAN; POLYMERIZATION; PRIORITY JOURNAL; SHELF LIFE; SURFACE CHARGE;

AIDS VACCINES; ANIMALS; BIOCOMPATIBLE MATERIALS; CELL SURVIVAL; CELLS, CULTURED; DRUG DELIVERY SYSTEMS; DRUG STABILITY; ELECTROPHORESIS, POLYACRYLAMIDE GEL; FEMALE; FLOW CYTOMETRY; FLUORESCENT ANTIBODY TECHNIQUE; GENE PRODUCTS, TAT; HIV-1; HUMANS; IMMUNOHISTOCHEMISTRY; MICE; MICE, INBRED BALB C; MICROSCOPY, ELECTRON, SCANNING; MICROSPHERES; OXIDATION-REDUCTION; PARTICLE SIZE; PHAGOCYTOSIS; PROTEIN CONFORMATION;

EID: 3142538773     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2003.12.025     Document Type: Article

References (71)

1. O'Hagan D.T. Recent advances in vaccine adjuvants for systemic and mucosal administration. J. Pharm. Pharmacol. 59:1998;1-10
2. Cahill E.S., O'Hagan D.T., Illum L., Bernard A., Mills K.H.J., Redhead K. Immune responses and protection against Bordetella pertussis infection after intranasal immunization of mice with filamentous hemagglutinin in solution or incorporated in biodegradable microparticles. Vaccine. 13:1995;455-462
3. Singh M., Li X.M., Wang H., McGee J.P., Zamb T., Koff W., et al. Immunogenicity and protection in small animal models with controlled release tetanus toxoid microparticles as a single-dose vaccine. Infect. Immun. 5:1997;1716-1721
4. Singh M., Li X.M., Wang H., McGee J.P., Zamb T., Koff W., et al. Controlled-release microparticles as a single dose diphteria toxoid vaccine: immunogenicity in small animal models. Vaccine. 16:1998;346-352
5. Allaoui-Attarki K., Fattal E., Pecquet S., Trolle S., Chachaty E., Couvreur P., et al. Mucosal immunogenicity elicited by oral vaccination with phosphorylcholine encapsulated in poly(DL-lactide-co-glycolide) microspheres. Vaccine. 16:1998;685-691
6. Aguado M.T., Lambert P.H. Controlled release vaccines: biodegradable polylactide/polyglycolide (PL/PG) microspheres as antigen vehicles. Immunobiology. 184:1992;113-125
7. Morris W., Steinhoff M.C., Russel P.K. Potential of polymer microencapsulation technology for vaccine innovation: review. Vaccine. 12:1994;5-11
8. Coombes A.G.A., Lavelle E.C., Jenkins P.G., Davis S.S. Single dose polymeric microparticulate vaccine delivery systems: the influence of formulation conditions on the magnitude and duration of the immune response to a protein antigen. Vaccine. 14:1996;1429-1438
9. Men Y., Thomasin C., Merkle H., Gander B. A single administration of tetanus toxoid in biodegradable microspheres elicit T cell and antibody responses similar or superior to those obtained with aluminium hydroxide. Vaccine. 13:1995;683-689
10. Jenkins P.G., Coombes A.G.A., Yeh M.K., Thomas N.W., Davis S.S. Aspects of the design and delivery of microparticles for vaccine applications. J. Drug Target. 3:1995;79-81
11. Rihova B. Biocompatibility of biomaterials: hemocompatibility. Adv. Drug Deliv. Rev. 21:1996;157-176
12. Anderson J.M., Shive M.S. Biodegradation and biocompatibility of PLA and PLGA microspheres. Adv. Drug Deliv. Rev. 28:1997;5-24
13. Nugent J., Wan Po L., Scott E. Design and delivery of non-parental vaccines: review. J. Clin. Pharm. Therap. 23:1998;257-285
14. Alpar H.O., Ward K.R., Williamson E.D. New strategies in vaccine delivery. S.T.P. Pharm. Sci. 10:2000;269-278
15. O'Hagan D.T., Rahman D., McGee J.P., Jeffery H., Davies M.C., Williams P., et al. Biodegradable microparticles as controlled release antigen delivery systems. Immunology. 73:1991;239-242
16. Eldridge J.H., Staas J.K., Meulbroek J.A., Tice T.R., Gilley R.M. 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. 59:1991;2978-2986
17. O'Hagan D.T., Jeffery H., Davis S.S. Long-term antibody responses in mice following subcutaneous immunization with ovalbumin entrapped in biodegradable microparticles. Vaccine. 11:1993;965-969
18. Nedrud JG, Lamm ME. Adjuvants and the mucosal immune system. In: Spriggs DR, Koff WC, editors. Topics in vaccine adjuvant research. Boca Raton: CRC Press; 1991. p. 51-67.
19. O'Hagan D.T., Singh M., Gupta R.K. Poly(lactide-co-glycolide) microparticles for the development of single-dose controlled-release vaccines. Adv. Drug Deliv. Rev. 32:1998;225-246
20. O'Hagan D.T. Recent developments in vaccine delivery systems. Curr. Drug Target. Infect. Disord. 1:2001;273-286
21. Laus M., Sparnacci K., Sante Angeloni A., Valenti S., Tondelli L. Microspheres with hydrophilic and protein-friendly surface as protein delivery systems prepared by dispersion polymerization. J. Control Rel. 72:2001;280-283
22. Cafaro A., Caputo A., Fracasso C., Maggiorella M.T., Goletti D., Baroncelli S., et al. Control of SHIV89.6P infection of cynomolgus monkeys by the HIV-1 Tat protein vaccine. Nat. Med. 5:1999;643-650
23. Cafaro A., Caputo A., Maggiorella M.T., Baroncelli S., Fracasso C., Pace M., et al. SHIV89.6P pathogenicity in cynomolgus monkeys and control of viral replication and disease onset by human immunodeficiency virus type 1 Tat vaccine. J. Med. Primatol. 29:2000;193-208
24. Osterhaus A.D.M.E., van Baalen C.A., Gruters R.A., Schutter M., Siebelink C.H., Hulskotte E.G., et al. Vaccination with Rev and Tat against AIDS. Vaccine. 17:1999;2713-2714
25. van Baalen C.A., Pontesilli O., Huisman R.E., Geretti A.M., Klein M.R., de Wolf F., et al. HIV-1 Rev and Tat specific cytotoxic T lymphocyte frequencies inversely correlates with rapid progression to AIDS. J. Gen. Virol. 78:1997;1913-1918
26. Arya S.K., Guo C., Joseph S.F., Wong-Staal F. The trans-activator gene of human T-lymphotropic virus type III (HTLV-III). Science. 229:1985;69-73
27. Ensoli B., Buonaguro L., Barillari G., Fiorelli V., Gendelman R., Morgan R.A., et al. Release, uptake, and effects of extracellular human immunodeficiency virus type 1 Tat protein on cell growth and viral transactivation. J. Virol. 67:1993;277-287
28. Chang H.C., Samaniego F., Nair B.C., Buonaguro L., Ensoli B. HIV-1 Tat protein exits from cells via a leaderless secretory pathway and binds to extracellular matrix-associated heparan sulfate proteoglycans through its basic region. AIDS. 11:1997;1421-1431
29. Fanales-Belasio E., Moretti S., Nappi F., Barillari G., Micheletti F., Cafaro A., et al. Native HIV-1 Tat protein targets monocyte-derived dendritic cells and enhances their maturation, function, and antigen-specific T cell responses. J. Immunol. 168:2002;197-206
30. Caselli E., Betti M., Grossi M.P., Balboni P.G., Rossi C., Boarini C., et al. DNA immunization with HIV-1 tat mutated in the transactivation domain induces humoral and cellular immune response against wild-type Tat. J. Immunol. 162:1999;5631-5638
31. Micheletti F., Monini P., Fortini C., Rimessi P., Bazzaro M., Andreoni M., et al. Identification of cytotoxic T lymphocyte epitopes of human herpesvirus 8. Immunology. 106:2002;395-403
32. Mosmann T. Rapid colorimetric assay for cellular growth and survival: application to proliferation and citotoxicity assays. J. Immunol. Methods. 65:1983;55-63
33. 2+ revealed by confocal microscopy. Microsc. Res. Tech. 36:1997;179-187
34. Betti M., Voltan R., Marchisio M., Mantovani I., Boarini C., Nappi F., et al. Characterization of HIV-1 Tat proteins mutated in the transactivation domain for prophylactic and therapeutic application. Vaccine. 19:2001;3408-3419
35. Davis LG, Dibner MD, Battey JF. In: Davis LG, Dibner MD, Battey JF, editors. Basic methods in molecular biology. New York: Elsevier; 1986.
36. Hsu S.-M., Raine L., Fanger H. Use of avidin-biotin-peroxidase complex (ABC) in immunoperoxidase techniques: a comparison between ABC and unlabeled antibody (PAP) procedures. J. Histochem. Cytochem. 29:1981;577-580
37. Sokak RR, Rohlf FJ. In: Socak RR, Rohlf FG, editors. Biometry: the principles and practice of statistics in biological research. San Francisco, CA: Freeman; 1981. p. 128-34.
38. Caldwell K.D. Surface modifications with adsorbed poly(ethylene oxide)-based block copolymers poly(ethylene glycol). ACS Symp. Ser. 680:1997;400-419
39. Gref R., Minamitake Y., Peracchia M.T., Domb A., Trubetskoy V., Torchilin V., et al. Poly(ethylene glycol)-coated nanospheres: potential carriers for intravenous drug administration. Pharm. Biotechnol. 10:1997;167-198
40. O'Hagan D.T. The intestinal uptake of particles and the implications for drug and antigen delivery. J. Anat. 189:1996;477-482
41. Araujo L., Sheppard M., Lobenberg R., Kreuter J. Uptake of PMMA nanoparticles from the gastrointestinal tract after oral administration to rats: modification of the body distribution after suspension in surfactant solutions and in oil vehicles. Intern. J. Pharmacol. 176:1999;209-224
42. Zauner W., Farrow N.A., Haines A.M.R. In vitro uptake of poly(styrene) microspheres: effect of particle size, cell line and cell density. J. Control Rel. 71:2001;39-51
43. Ensoli B., Gendelman R., Markham P., Fiorelli V., Colombini S., Raffeld M., et al. Synergy between basic fibroblast growth factor and HIV-1 Tat protein in induction of Kaposi's sarcoma. Nature. 371:1994;674-680
44. Fernandez-Urrusuno R., Fattal E., Rodriguez J.M., Feger J., Bedossa P., Couvreur P. Effect of polymeric nanoparticle administration on the clearance activity of the mononuclear phagocyte system in mice. J. Biomed. Mater. Res. 31:1996;401-408
45. Carr K.E., Hazzard R.A., Reid S., Hodges G.M. The effect of size on uptake of orally administered latex microparticles in the small intestine and transport to mesenteric lymph nodes. Pharmacol. Res. 13:1996;1205-1209
46. Zimmer A., Kreuter J. Microspheres and nanoparticles used in ocular delivery systems. Adv. Drug Deliv. Rev. 16:1995;61-73
47. Zhao Z., Leong K.W. Controlled delivery of antigens and adjuvants in vaccine development. J. Pharm. Sci. 85:1996;1261-1270
48. Kreuter J. Physicochemical characterization of nanoparticles and their potential for vaccine preparation. Vaccine Res. 1:1992;93-98
49. Stieneker F., Lower J., Kreuter J. Different kinetics of the humoral immune response to inactivated HIV-1 and HIV-2 in mice: modulation by PMMA nanoparticle adjuvant. Vaccine Res. 2:1993;111-118
50. Kreuter J., Nefzger M., Liehl E., Czok R., Vogels R. Distribution and elimination of poly(methyl methacrylate) nanoparticles after subcutaneous administration to rats. J. Pharm. Sci. 72:1983;1146-1149
51. Borchard G., Kreuter J. Interaction of serum components with poly(methyl methacrylate) nanoparticles and the resulting body distribution after intravenous injection in rats. J. Drug Target. 1:1993;15-19
52. Maincent P., Thouvenot P., Amicabile C., Hoffman M., Kreutes J., Couvreur P., et al. Lymphatic targeting of polymeric nanoparticles after intraperitoneal administration in rats. Pharmacol. Res. 9:1992;1534-1539
53. Eldridge J.H., Hammond C.J., Meulbroek J.A., Staas J.K., Gilley R.M., Tice T.R. Controlled vaccine release in the gut-associated lymphoid tissues. I. Orally administered biodegradable microspheres target the Peyer's patches. J. Control Rel. 11:1990;205-214
54. Rolland A., Collet B., Le Verge R., Toujas L. Blood clearance and organ distribution of intravenously administered polymethacrylic nanoparticles in mice. J. Pharm. Sci. 78:1989;481-484
55. Nefzger M., Kreuter J., Voges R., Liehl E., Czok R. Distribution and elimination of poly(methyl methacrylate) nanoparticles after peroral administration to rats. J. Pharm. Sci. 73:1984;1309-1311
56. 14C -methacrylate) nanoparticle radioactivity after injection in rats and mice J. Pharm. Sci. 68:1979;1443-1447
57. Dittgen M., Durrani M., Klehmann K. Acrylic polymers: a review of pharmaceutical applications. STP Pharm. Sci. 7:1997;403-437
58. Arthur J., Butterfield L.H., Roth M.D., Bui L.A., Kiertscher S.M., Lau R., et al. A comparison of gene transfer methods in human dendritic cells. Cancer Gene Ther. 4:1997;17-25
59. Thierry A.R., Rabinovich P., Peng B., Mahan L.C., Bryant J.L., Gallo R.C. Characterization of liposome-mediated gene delivery. Expression, stability and pharmacokinetics of plasmid DNA. Gene Ther. 4:1997;226-237
60. Kersten G.F.A., Crommelin D.J.A. Liposomes and ISCOMS as vaccine formulations. Vaccine. 21:2003;915-920
61. Johansen P., Men Y., Merkle H.P., Gander B. Revisiting PLA/PLGA microspheres: an analysis of their potential in parenteral vaccination. Eur. J. Pharm. Biopharm. 50:2000;129-146
62. Hanes J., Cleland J.L., Langer R. New advances in microsphere-based single-dose vaccines. Adv. Drug Deliv. Rev. 28:1997;97-119
63. Sparnacci K., Laus M., Tondelli L., Magnani L., Bernardi C. Core-shell microspheres by dispersion polymerization as drug delivery systems. Macromol. Chem. Phys. 203:2002;1364-1369
64. van de Weert M., Hennink W.E., Jiskoot W. Protein instability in poly(lactic-co-glycolic acid) microparticles. Pharmacol. Res. 17:2000;1159-1167
65. Kazzaz J., Neidleman J., Singh M., Ott G., O'Hagan D.T. Novel anionic microparticles are a potent adjuvant for the induction of cytotoxic T lymphocytes against human recombinant p55 gag from HIV-1. J. Control Rel. 67:2000;347-356
66. Otten G., Schaefer M., Greer C., Calderon-Cacia M., Coit D., Kazzaz J., et al. Induction of broad and potent anti-human immunodeficiency virus immune responses in rhesus macaques by priming with a DNA vaccine and boosting with protein-adsorbed polylactide coglycolide microparticles. J. Virol. 77:2003;6087-6092
67. Jabbal-Gill I., Lin W., Jenkins P., Watts P., Jimenez M., Illun L., et al. Potential of polymeric lamellar substrate particles (PLSP) as adjuvants for vaccines. Vaccine. 18:1999;238-250
68. Corinti S., Chiarantini L., Dominici S., Laguardia M.E., Magnani M., Girolomoni G., et al. Erythrocytes deliver Tat to interferon-γ-treated human dendritic cells for efficient initiation of specific type 1 immune response in vitro. J. Leukoc. Biol. 71:2002;652-658
69. Cafaro A., Titti F., Fracasso C., Maggiorella M.T., Baroncelli S., Caputo A., et al. Vaccination with DNA containing tat coding sequences and unmethylated CpG motifs protects cynomolgus monkeys upon infection with simian/human immunodeficiency virus (SHIV89.6P). Vaccine. 19:2001;2862-2877
70. Verrier B., Le Grand R., Ataman-Onal Y., Terrat C., Guillon C., Durand P.Y., et al. Evaluation in rhesus macaques of Tat and Rev-targeted immunization as preventive vaccine against mucosal challenge with SHIV-BX08. DNA Cell Biol. 21:2002;653-658
71. Agwale S.M., Shata M.T., Reitz M.S., Kalyanaraman V.S., Gallo R.C., Popovic M., et al. A Tat subunit vaccine confers protective immunity against the immune-modulating activity of the human immunodeficiency virus type-1 Tat protein in mice. Proc. Natl. Acad. Sci. U.S.A. 99:2002;10037-10041