메뉴 건너뛰기




Volumn 28, Issue 8, 2009, Pages 479-491

Toxicology and biodistribution study of CIGB-230, a DNA vaccine against hepatitis C virus

Author keywords

DNA vaccine; HCV; Systemic effects; Tissue; Toxicity

Indexed keywords

CIGB 230; DNA VACCINE; PLACEBO; UNCLASSIFIED DRUG;

EID: 70349687252     PISSN: 09603271     EISSN: None     Source Type: Journal    
DOI: 10.1177/0960327109106438     Document Type: Article
Times cited : (8)

References (47)
  • 2
    • 0642280874 scopus 로고    scopus 로고
    • DNA vaccination: An update
    • Lowrie, DB DNA vaccination: an update. Methods Mol Med 2003 ; 87: 377 - 390.
    • (2003) Methods Mol Med , vol.87 , pp. 377-390
    • Lowrie, D.B.1
  • 3
    • 0032210747 scopus 로고    scopus 로고
    • DNA vaccination with HIV-1 expressing constructs elicits immune responses in humans
    • Ugen, KE, Nyland, SB, Boyer, JD, Vidal, C., Lera, L., Rasheid, S., et al. DNA vaccination with HIV-1 expressing constructs elicits immune responses in humans. Vaccine 1998 ; 16: 1818 - 1821.
    • (1998) Vaccine , vol.16 , pp. 1818-1821
    • Ugen, K.E.1    Nyland, S.B.2    Boyer, J.D.3    Vidal, C.4    Lera, L.5    Rasheid, S.6
  • 4
    • 0038362648 scopus 로고    scopus 로고
    • Technical and regulatory hurdles for DNA vaccines
    • Donnelly, J., Berry, K., Ulmer, JB Technical and regulatory hurdles for DNA vaccines. Int J Parasitol 2003 ; 33: 457 - 467.
    • (2003) Int J Parasitol , vol.33 , pp. 457-467
    • Donnelly, J.1    Berry, K.2    Ulmer, J.B.3
  • 6
    • 10444271714 scopus 로고    scopus 로고
    • Biodistribution and general safety of a naked DNA plasmid, GTU-MultiHIV, in a rat, using a quantitative PCR method
    • Tuomela, M., Malm, M., Wallen, M., Stanescu, I., Krohn, K., Peterson, P. Biodistribution and general safety of a naked DNA plasmid, GTU-MultiHIV, in a rat, using a quantitative PCR method. Vaccine 2005 ; 23: 890 - 896.
    • (2005) Vaccine , vol.23 , pp. 890-896
    • Tuomela, M.1    Malm, M.2    Wallen, M.3    Stanescu, I.4    Krohn, K.5    Peterson, P.6
  • 7
    • 32044459506 scopus 로고    scopus 로고
    • Definitive toxicology and biodistribution study of a polyvalent DNA prime/protein boost human immunodeficiency virus type 1 (HIV-1) vaccine in rabbits
    • Pal, R., Yu, Q., Wang, S., Kalyanaraman, VS, Nair, BC, Hudacik, L., et al. Definitive toxicology and biodistribution study of a polyvalent DNA prime/protein boost human immunodeficiency virus type 1 (HIV-1) vaccine in rabbits. Vaccine 2006 ; 24: 1225 - 1234.
    • (2006) Vaccine , vol.24 , pp. 1225-1234
    • Pal, R.1    Yu, Q.2    Wang, S.3    Kalyanaraman, V.S.4    Nair, B.C.5    Hudacik, L.6
  • 8
    • 33645016634 scopus 로고    scopus 로고
    • Tissue distribution of a plasmid DNA encoding Hsp65 gene is dependent on the dose administered through intramuscular delivery
    • Coelho-Castelo, AA, Trombone, AP, Rosada, RS, Santos Jr, RR, Bonato, VL, Sartori, A., et al. Tissue distribution of a plasmid DNA encoding Hsp65 gene is dependent on the dose administered through intramuscular delivery. Genet Vaccines Ther 2006 ; 4: 1.
    • (2006) Genet Vaccines Ther , vol.4 , pp. 1
    • Coelho-Castelo, A.A.1    Trombone, A.P.2    Rosada, R.S.3    Santos Jr., R.R.4    Bonato, V.L.5    Sartori, A.6
  • 9
    • 33845876613 scopus 로고    scopus 로고
    • Optimization and delivery of plasmid DNA for vaccination
    • Jechlinger, W. Optimization and delivery of plasmid DNA for vaccination. Expert Rev Vaccines 2006 ; 5: 803 - 825.
    • (2006) Expert Rev Vaccines , vol.5 , pp. 803-825
    • Jechlinger, W.1
  • 10
    • 33847120795 scopus 로고    scopus 로고
    • Biodistribution and tissue expression kinetics of plasmid DNA complexed with polyethylenimines of different molecular weight and structure
    • Jeong, GJ, Byun, HM, Kim, JM, Yoon, H., Choi, HG, Kim, WK, et al. Biodistribution and tissue expression kinetics of plasmid DNA complexed with polyethylenimines of different molecular weight and structure. J Control Release 2007 ; 118: 118 - 125.
    • (2007) J Control Release , vol.118 , pp. 118-125
    • Jeong, G.J.1    Byun, H.M.2    Kim, J.M.3    Yoon, H.4    Choi, H.G.5    Kim, W.K.6
  • 11
    • 1942443062 scopus 로고    scopus 로고
    • Liposome-mediated DNA immunisation via the subcutaneous route
    • Perrie, Y., McNeil, S., Vangala, A. Liposome-mediated DNA immunisation via the subcutaneous route. J Drug Target 2003 ; 11: 555 - 563.
    • (2003) J Drug Target , vol.11 , pp. 555-563
    • Perrie, Y.1    McNeil, S.2    Vangala, A.3
  • 12
    • 2342584873 scopus 로고    scopus 로고
    • IONP-PLL: A novel non-viral vector for efficient gene delivery
    • Xiang, JJ, Tang, JQ, Zhu, SG, Nie, XM, Lu, HB, Shen, SR, et al. IONP-PLL: a novel non-viral vector for efficient gene delivery. J Gene Med 2003 ; 5: 803 - 817.
    • (2003) J Gene Med , vol.5 , pp. 803-817
    • Xiang, J.J.1    Tang, J.Q.2    Zhu, S.G.3    Nie, X.M.4    Lu, H.B.5    Shen, S.R.6
  • 13
    • 34248676278 scopus 로고    scopus 로고
    • Gastrointestinal distribution and in vivo gene transfection studies with nanoparticles-in-microsphere oral system (NiMOS)
    • Bhavsar, MD, Amiji, MM Gastrointestinal distribution and in vivo gene transfection studies with nanoparticles-in-microsphere oral system (NiMOS). J Control Release 2007 ; 119: 339 - 348.
    • (2007) J Control Release , vol.119 , pp. 339-348
    • Bhavsar, M.D.1    Amiji, M.M.2
  • 14
    • 38949155209 scopus 로고    scopus 로고
    • Carassius auratus-originated recombinant histone H1 C-Terminal peptide as gene delivery material
    • Jung, HJ, Hwang, DS, Wei, QD, Cha, HJ Carassius auratus-originated recombinant histone H1 C-Terminal peptide as gene delivery material. Biotechnol Prog 2008 ; 24: 17 - 22.
    • (2008) Biotechnol Prog , vol.24 , pp. 17-22
    • Jung, H.J.1    Hwang, D.S.2    Wei, Q.D.3    Cha, H.J.4
  • 15
    • 0346496235 scopus 로고    scopus 로고
    • A multi-domain protein system based on the HC fragment of tetanus toxin for targeting DNA to neuronal cells
    • Box, M., Parks, DA, Knight, A., Hale, C., Fishman, PS, Fairweather, NF A multi-domain protein system based on the HC fragment of tetanus toxin for targeting DNA to neuronal cells. J Drug Target 2003 ; 11: 333 - 343.
    • (2003) J Drug Target , vol.11 , pp. 333-343
    • Box, M.1    Parks, D.A.2    Knight, A.3    Hale, C.4    Fishman, P.S.5    Fairweather, N.F.6
  • 16
    • 0142169015 scopus 로고    scopus 로고
    • A recombinant H1 histone-based system for efficient delivery of nucleic acids
    • Puebla, I., Esseghir, S., Mortlock, A., Brown, A., Crisanti, A., Low, W. A recombinant H1 histone-based system for efficient delivery of nucleic acids. J Biotechnol 2003 ; 105: 215 - 226.
    • (2003) J Biotechnol , vol.105 , pp. 215-226
    • Puebla, I.1    Esseghir, S.2    Mortlock, A.3    Brown, A.4    Crisanti, A.5    Low, W.6
  • 19
  • 20
    • 33645678288 scopus 로고    scopus 로고
    • Hepatitis C virus (HCV) core protein enhances the immunogenicity of a co-delivered DNA vaccine encoding HCV structural antigens in mice
    • Alvarez-Lajonchere, L., Gonzalez, M., Alvarez-Obregon, JC, Guerra, I., Vina, A., Acosta-Rivero, N., et al. Hepatitis C virus (HCV) core protein enhances the immunogenicity of a co-delivered DNA vaccine encoding HCV structural antigens in mice. Biotechnol Appl Biochem 2006 ; 44: 9 - 17.
    • (2006) Biotechnol Appl Biochem , vol.44 , pp. 9-17
    • Alvarez-Lajonchere, L.1    Gonzalez, M.2    Alvarez-Obregon, J.C.3    Guerra, I.4    Vina, A.5    Acosta-Rivero, N.6
  • 22
    • 0033391707 scopus 로고    scopus 로고
    • Variable level expression of hepatitis C virus core protein in a prokaryotic system. Analysis of the humoral response in rabbit
    • Dueñas-Carrera, S., Morales, J., Acosta-Rivero, N., et al. Variable level expression of hepatitis C virus core protein in a prokaryotic system. Analysis of the humoral response in rabbit. Biotecnologóa Aplicada 1999 ; 16: 226 - 231.
    • (1999) Biotecnologóa Aplicada , vol.16 , pp. 226-231
    • Dueñas-Carrera, S.1    Morales, J.2    Acosta-Rivero, N.3
  • 23
    • 22744456428 scopus 로고    scopus 로고
    • A C-terminal truncated hepatitis C virus core protein variant assembles in vitro into virus-like particles in the absence of structured nucleic acids
    • Acosta-Rivero, N., Rodriguez, A., Mussachio, A., Poutou, J., Falcon, V., Torres, D., et al. A C-terminal truncated hepatitis C virus core protein variant assembles in vitro into virus-like particles in the absence of structured nucleic acids. Biochem Biophys Res Commun 2005 ; 334: 901 - 906.
    • (2005) Biochem Biophys Res Commun , vol.334 , pp. 901-906
    • Acosta-Rivero, N.1    Rodriguez, A.2    Mussachio, A.3    Poutou, J.4    Falcon, V.5    Torres, D.6
  • 26
    • 70349705660 scopus 로고    scopus 로고
    • On the harmonization of laws, regulations and administrative provisions relating to the application of the principle of good laboratory practice and the verification of their applications for test on chemical substances
    • Directive 2004/10/EC of the European Parliament and of the Council
    • Directive 2004/10/EC of the European Parliament and of the Council. On the harmonization of laws, regulations and administrative provisions relating to the application of the principle of good laboratory practice and the verification of their applications for test on chemical substances. Official Journal of the European Union: L 50/44-L 50/59, 2004.
    • (2004) Official Journal of the European Union: L 50/44-L 50/59
  • 27
    • 0001748577 scopus 로고
    • Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
    • EEC
    • EEC. Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Offical Journal of the European Communities 1986; L358: 1-29.
    • (1986) Offical Journal of the European Communities , vol.L358 , pp. 1-29
  • 28
    • 70349656530 scopus 로고    scopus 로고
    • Animal alternatives, welfare and ethics
    • NRC. National Research Council In: van Zutphen, LFM, Balls, M, (eds) Elsevier Science, New York
    • NRC. National Research Council. Animal alternatives, welfare and ethics. In: van Zutphen, LFM, Balls, M, (eds), Developments in animal and veterinary sciences. 1997, Elsevier Science, New York: 291 - 296.
    • (1997) Developments in Animal and Veterinary Sciences , pp. 291-296
  • 29
    • 70349690214 scopus 로고    scopus 로고
    • On the Accommodation and Care of Animals Used for Experimental and Other Purposes
    • Euroguide Royal Society of Medicine Press Ltd., London, UK
    • Euroguide. On the accommodation and care of animals used for experimental and other purposes. FELASA ; 2007, Royal Society of Medicine Press Ltd., London, UK.
    • (2007) FELASA
  • 30
    • 70349659710 scopus 로고    scopus 로고
    • No-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
    • CPMP/ICH/286/95
    • CPMP/ICH/286/95. No-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. ICH M3 (M), 2000.
    • (2000) ICH M3 (M)
  • 32
    • 70349667203 scopus 로고    scopus 로고
    • Regulation No. 39/04 from the National Regulatory Agency (CECMED) that rules scientific procedures on animals in Cuba
    • Regulation No. 39/04 from The National Regulatory Agency (CECMED) that rules scientific procedures on animals in Cuba, GPL of non Clinical Laboratory of sanitary safety and environmental, 2004.
    • (2004) GPL of Non Clinical Laboratory of Sanitary Safety and Environmental
  • 33
    • 21844471782 scopus 로고    scopus 로고
    • Phase i study of a plasmid DNA vaccine encoding MART-1 in patients with resected melanoma at risk for relapse
    • Triozzi, PL, Aldrich, W., Allen, KO, Carlisle, RR, LoBuglio, AF, Conry, RM Phase I study of a plasmid DNA vaccine encoding MART-1 in patients with resected melanoma at risk for relapse. J Immunother 2005 ; 28: 382 - 388.
    • (2005) J Immunother , vol.28 , pp. 382-388
    • Triozzi, P.L.1    Aldrich, W.2    Allen, K.O.3    Carlisle, R.R.4    Lobuglio, A.F.5    Conry, R.M.6
  • 34
    • 39149128276 scopus 로고    scopus 로고
    • A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial
    • Martin, JE, Pierson, TC, Hubka, S., Rucker, S., Gordon, IJ, Enama, ME, et al. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis 2007 ; 196: 1732 - 1740.
    • (2007) J Infect Dis , vol.196 , pp. 1732-1740
    • Martin, J.E.1    Pierson, T.C.2    Hubka, S.3    Rucker, S.4    Gordon, I.J.5    Enama, M.E.6
  • 35
    • 0035007717 scopus 로고    scopus 로고
    • Hepatic uptake and gene expression mechanisms following intravenous administration of plasmid DNA by conventional and hydrodynamics-based procedures
    • Kobayashi, N., Kuramoto, T., Yamaoka, K., Hashida, M., Takakura, Y. Hepatic uptake and gene expression mechanisms following intravenous administration of plasmid DNA by conventional and hydrodynamics-based procedures. J Pharmacol Exp Ther 2001 ; 297: 853 - 860.
    • (2001) J Pharmacol Exp Ther , vol.297 , pp. 853-860
    • Kobayashi, N.1    Kuramoto, T.2    Yamaoka, K.3    Hashida, M.4    Takakura, Y.5
  • 36
    • 0035859974 scopus 로고    scopus 로고
    • Nasal absorption and biodistribution of plasmid DNA: An alternative route of DNA vaccine delivery
    • Oh, YK, Kim, JP, Hwang, TS, Ko, JJ, Kim, JM, Yang, JS, et al. Nasal absorption and biodistribution of plasmid DNA: an alternative route of DNA vaccine delivery. Vaccine 2001 ; 19: 4519 - 4525.
    • (2001) Vaccine , vol.19 , pp. 4519-4525
    • Oh, Y.K.1    Kim, J.P.2    Hwang, T.S.3    Ko, J.J.4    Kim, J.M.5    Yang, J.S.6
  • 37
    • 0029049810 scopus 로고
    • The fate of plasmid DNA after intravenous injection in mice: Involvement of scavenger receptors in its hepatic uptake
    • Kawabata, K., Takakura, Y., Hashida, M. The fate of plasmid DNA after intravenous injection in mice: involvement of scavenger receptors in its hepatic uptake. Pharm Res 1995 ; 12: 825 - 830.
    • (1995) Pharm Res , vol.12 , pp. 825-830
    • Kawabata, K.1    Takakura, Y.2    Hashida, M.3
  • 38
    • 1242286566 scopus 로고    scopus 로고
    • Biodistribution and safety studies of hDel-1 plasmid-based gene therapy in mouse and rabbit models
    • Quezada, A., Larson, J., French, M., Ponce, R., Perrard, J., Durland, R., et al. Biodistribution and safety studies of hDel-1 plasmid-based gene therapy in mouse and rabbit models. J Pharm Pharmacol 2004 ; 56: 177 - 185.
    • (2004) J Pharm Pharmacol , vol.56 , pp. 177-185
    • Quezada, A.1    Larson, J.2    French, M.3    Ponce, R.4    Perrard, J.5    Durland, R.6
  • 39
    • 0034141872 scopus 로고    scopus 로고
    • Cell-mediated DNA transport between distant inflammatory sites following intradermal DNA immunization in the presence of adjuvant
    • La Cava, A., et al. Cell-mediated DNA transport between distant inflammatory sites following intradermal DNA immunization in the presence of adjuvant. J Immunol 2000 ; 164: 1340 - 1345.
    • (2000) J Immunol , vol.164 , pp. 1340-1345
    • La Cava, A.1
  • 40
    • 0034283956 scopus 로고    scopus 로고
    • Distribution of DNA vaccines determines their immunogenicity after intramuscular injection in mice
    • Dupuis, M., et al. Distribution of DNA vaccines determines their immunogenicity after intramuscular injection in mice. J Immunol 2000 ; 165: 2850 - 2858.
    • (2000) J Immunol , vol.165 , pp. 2850-2858
    • Dupuis, M.1
  • 41
    • 0034469447 scopus 로고    scopus 로고
    • Plasmid DNA vaccines: Tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA
    • Manam, S., et al. Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Inter-virology 2000 ; 43: 273 - 281.
    • (2000) Inter-virology , vol.43 , pp. 273-281
    • Manam, S.1
  • 42
    • 0034760639 scopus 로고    scopus 로고
    • Slow accumulation of plasmid in muscle cells: Supporting evidence for a mechanism of DNA uptake by receptor-mediated endocytosis
    • Satkauskas, S., Bureau, MF, Mahfoudi, A., Mir, LM Slow accumulation of plasmid in muscle cells: supporting evidence for a mechanism of DNA uptake by receptor-mediated endocytosis. Mol Ther 2001 ; 4: 317 - 323.
    • (2001) Mol Ther , vol.4 , pp. 317-323
    • Satkauskas, S.1    Bureau, M.F.2    Mahfoudi, A.3    Mir, L.M.4
  • 43
    • 0025279872 scopus 로고
    • Gene transfer by retrovirus vectors occurs only in cells that are actively replicating at the time of infection
    • Miller, DG, Adam, MA, Miller, AD Gene transfer by retrovirus vectors occurs only in cells that are actively replicating at the time of infection. Mol Cell Biol 1990 ; 10: 4239 - 4242.
    • (1990) Mol Cell Biol , vol.10 , pp. 4239-4242
    • Miller, D.G.1    Adam, M.A.2    Miller, A.D.3
  • 44
    • 33645910865 scopus 로고    scopus 로고
    • Long-term persistence of hepatitis B surface antigen and antibody induced by DNA-mediated immunization results in liver and kidney lesions in mice
    • Zi, XY, et al. Long-term persistence of hepatitis B surface antigen and antibody induced by DNA-mediated immunization results in liver and kidney lesions in mice. Eur J Immunol 2006 ; 36: 875 - 86.
    • (2006) Eur J Immunol , vol.36 , pp. 875-86
    • Zi, X.Y.1
  • 45
    • 0038732473 scopus 로고    scopus 로고
    • Species differences in the structure and function of immune system
    • Haley, P. Species differences in the structure and function of immune system. Toxicology 2003 ; 188: 49 - 71.
    • (2003) Toxicology , vol.188 , pp. 49-71
    • Haley, P.1
  • 46
    • 70349687143 scopus 로고    scopus 로고
    • Repeated dose toxicity
    • Hayes, W, (ed), 4th ed. Philadelphia : Taylor and Francis;
    • DiPasquale, L., Hayes, W. Repeated dose toxicity. In: Hayes, W, (ed), Principles and methods of toxicology. 4 th ed. Philadelphia: Taylor and Francis ; 2001: 959 - 1000.
    • (2001) Principles and Methods of Toxicology , pp. 959-1000
    • Dipasquale, L.1    Hayes, W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.