Biodistribution of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar, without integration, despite differing plasmid backbones or gene inserts

Toxicological Sciences

Volumn 91, Issue 2, 2006, Pages 610-619

  Sheets, Rebecca L ^a   Stein, Judith ^a   Manetz, T Scott ^b   Duffy, Chris ^c   Nason, Martha ^a   Andrews, Charla ^a   Kong, Wing Pui ^a   Nabel, Gary J ^a   Gomez, Phillip L ^a  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b Gene Logic Inc   (United States)

^c Althea Technologies   (United States)

Author keywords

DNA vaccine biodistribution; DNA vaccine integration; DNA vaccines; Ebola; HIV AIDS; Plasmid vaccines; SARS; WNV

Indexed keywords

DNA VACCINE; EBOLA VACCINE; GAG PROTEIN; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; NEF PROTEIN; PLASMID DNA; POL PROTEIN; SEVERE ACUTE RESPIRATORY SYNDROME VACCINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VIRUS ENVELOPE PROTEIN; VIRUS GLYCOPROTEIN; VIRUS NUCLEOPROTEIN; VIRUS SPIKE PROTEIN; VIRUS VACCINE; VRC 2805; VRC 3900; VRC 4302; VRC 4306; VRC 4311; VRC 4313; VRC 5305; VRC 5309; VRC 6001; VRC 6201; VRC 6204; VRC 6301; VRC 6402; VRC 6605; VRC 8318; WEST NILE VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DNA DETERMINATION; DNA EXTRACTION; DNA INTEGRATION; DNA STRUCTURE; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG SAFETY; DRUG TISSUE LEVEL; EBOLA VIRUS; FEMALE; GENE EXPRESSION; GENE INSERTION; GENETIC CODE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; MALE; MOUSE; NEEDLE; NONHUMAN; NUCLEOTIDE SEQUENCE; PHASE 1 CLINICAL TRIAL; PROMOTER REGION; SARS CORONAVIRUS; SEVERE ACUTE RESPIRATORY SYNDROME; VIRUS INFECTION; VIRUS STRAIN; WEST NILE FLAVIVIRUS;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ANIMALS; EBOLAVIRUS; FEMALE; GENES, VIRAL; HEMORRHAGIC FEVER, EBOLA; HIV-1; INJECTIONS, INTRAMUSCULAR; INJECTIONS, INTRAVENOUS; MALE; MICE; MICE, INBRED STRAINS; PLASMIDS; PROMOTER REGIONS (GENETICS); SEVERE ACUTE RESPIRATORY SYNDROME; TISSUE DISTRIBUTION; VACCINES, DNA; VIRAL VACCINES; WEST NILE FEVER; WEST NILE VIRUS;

ANIMALIA; EBOLA VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1; ORYCTOLAGUS CUNICULUS; SARS CORONAVIRUS; WEST NILE VIRUS;

EID: 33744790917     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfj169     Document Type: Article

References (19)

1. Barouch, D., Truitt, D. M., and Letvin, N. L. (2004). Expression kinetics of the interleukin-2/immunoglobulin (IL-2/Ig) plasmid cytokine adjuvant. Vaccine 22, 3092-3097.
2. Barouch, D., Yang, Z.-Y., Kong, W.-P., Korioth-Schmitz, B., Sumida, S. M., Truitt, D. M., Kishko, M. G., Arthur, J. C., Miura, A., Mascola, J. R., et al. (2005). An HTLV-1 regulatory element enhances the immunogenicity of HIV-1 DNA vaccines in mice and nonhuman primates. J. Virol. 79, 9694-9701.
3. CBER. (1996). Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications. CBER.
4. CBER. (2005). Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. CBER.
5. Chakrabarti, B. K., Kong, W.-P., Wu, B.-Y., Yang, Z.-Y., Friborg, J., Ling, X., King, S. R., Montifiori, D. C., and Nabel, G. J. (2002). Modifications of the human immunodeficiency virus envelope glycoprotein enhances immunogenicity for genetic immunization. J. Virol. 76, 5357-5368.
6. Epstein, J. E., Gorak, E. J., Charoenvit, Y., Wang, R., Freydberg, N., Osinowo, O., Richie, T. L., Stoltz, E. L., Trespalacios, F., and Nerges, J. (2002). Safety, tolerability, and lack of antibody responses after administration of a PfCSP DNA malaria vaccine via needle or needle-free jet injection, and comparison of intramuscular and combination intramuscular/intradermal routes. Hum. Gene Ther. 13, 1551-1560.
7. Epstein, J. E., Charoenvit, Y., Kester, K. E., Wang, R., Newcomer, R., Fitzpatrick, S., Richie, T. L., Tornieporth, N., Heppner, D. G., and Ockenhouse, C., (2004). Safety, tolerability, and antibody responses in humans after sequential immunization with a PfCSP DNA vaccine followed by the recombinant protein vaccine RTS,S/AS02A. Vaccine 22, 1592-1603.
8. Martin J. E., Enama M. E., Koup R. A., Bailer R. T., Moodie Z., Roederer M., Nabel G. J., and Graham B. S. (2005) VRC 004: Safety and Immunogenicity of a Multiclade HIV-1 DNA Vaccine in Healthy Uninfected Adults (VRCHIVDNA009-00-VP). J. Allergy. Clin. Immunol. 115, 892.
9. Hartikka, J., Sawdey, M., Cornefert-Jensen, F., Margalith, M., Barnhart, K., Nolasco, M., Vahlsing, H. L., Meek, J., Marquet, M., and Hobart, P. (1996). An improved plasmid DNA expression vector for direct injection into skeletal muscle. Hum. Gene Ther. 7, 1205-1217.
10. Huang, Y., Kong, W.-P., and Nabel, G. J. (2001). Human immunodeficiency virus type 1-specific immunity after genetic immunization is enhanced by modification of Gag and Pol expression. J. Virol. 75, 4947-4951.
11. Kong,W.-P., Huang, Y., Yang, Z.-Y., Chakrabarti, B. K., Moodie, Z., and Nabel, G. J. (2003). Immunogenicity of multiple gene and clade human immunodeficiency virus type 1 DNA vaccines. J. Virol. 77, 12764-12772.
12. Sheets, R. L., Stein, J., Manetz, T. S., Andrews, C., Bailer, R., Rathmann, J., and Gomez, P. L. (2006). Toxicological Safety Evaluation of DNA Plasmid Vaccines Against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile Virus is Similar Despite Differing Plasmid Backbones or Gene Inserts.
13. Sullivan, N. J., Peterson, M., Yang, Z. Y., Kong, W. P., Duckers, H., Nabel, E., and Nabel, G. J. (2005). Ebola virus glycoprotein toxicity is mediated by a dynamin-dependent protein-trafficking pathway. J. Virol. 79, 547-553.
14. Sullivan, N. J., Sanchez, A., Rollin, P. E., Yang, Z. Y., and Nabel, G. J. (2000). Development of a preventive vaccine for Ebola virus infection in primates. Nature 408, 605-609.
15. Title 21 Code of Federal Regulations (CFR). Part 58.
16. Ulmer, J. B., Sadoff, J. C., and Liu, M. A. (1996). DNA vaccines. Curr. Opin. Immunol. 8, 531-536.
17. Wang, Z., Troilo, P. J., Wang, X., Griffiths, T. G., Pacchione, S. J., Barnum, A. B., Harper, L. B., Pauley, C. J., Niu, Z., Denisova, L., et al. (2004). Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther. 11, 711-721.
18. Xu, L., Sanchez, A., Yang, Z., Zaki, S. R., Nabel, E. G., Nichol, S. T., and Nabel, G.J. (1998). Immunization for Ebola virus infection. Nat. Med. 4, 37-42.
19. Yang, Z.-Y., Kong,W.-P., Huang, Y., Roberts, A., Murphy, B. R., Subbarao, K., and Nabel, G. J. (2004). A DNA vaccine induces SARS coronavirus neutralization and protective immunity in mice. Nature 428, 561-564.