Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, or Marburg are similar despite differing adenovirus serotype vector, manufacturer's construct, or gene inserts

Journal of Immunotoxicology

Volumn 5, Issue 3, 2008, Pages 315-335

  Sheets, Rebecca L ^a,f   Stein, Judith ^a   Bailer, Robert T ^a   Koup, Richard A ^a   Andrews, Charla ^a   Nason, Martha ^a   He, Bin ^b   Koo, Edward ^b   Trotter, Holly ^c   Duffy, Chris ^c   Manetz, T Scott ^d   Gomez, Phillip ^e  

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

^b Bridge Laboratories   (United States)

^c Althea Technologies   (United States)

^d MEDIMMUNE   (United States)

^e PRTM   (United States)

^f PRTM ^*

Author keywords

Adenovirus type 35; Adenovirus type 5; Adenovirus vector; Biodistribution; Ebola; HIV 1; Marburg; Repeated dose toxicology; Safety; Vaccine

Indexed keywords

ADENOVIRUS VECTOR; EBOLA VACCINE; GENOMIC DNA; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; MARBURG VIRUS VACCINE; PLACEBO; PLASMID DNA; UNCLASSIFIED DRUG; VIRUS DNA; VIRUS ENVELOPE PROTEIN; VIRUS GLYCOPROTEIN; VIRUS VACCINE;

ADENOVIRUS 35; ADENOVIRUS 5; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BODY TEMPERATURE; BODY WEIGHT; CONTROLLED STUDY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG SAFETY; EBOLA VIRUS; FEMALE; FOOD INTAKE; GENE CONSTRUCT; GENE INSERTION; HUMAN IMMUNODEFICIENCY VIRUS 1; ILIAC LYMPH NODE; IMMUNOGENICITY; IMMUNOTOXICITY; INJECTION SITE; LIVER; LYMPH NODE; MALE; MARBURG VIRUS; MUSCLE; NONHUMAN; PRIORITY JOURNAL; RABBIT; SPLEEN; SUBCUTANEOUS TISSUE; TISSUE DISTRIBUTION; VACCINE PRODUCTION; VIRUS GENOME; VIRUS PARTICLE;

ADENOVIRIDAE; AIDS VACCINES; ANIMALS; ANTIBODIES, VIRAL; DNA, VIRAL; DRUG EVALUATION, PRECLINICAL; EBOLA VACCINES; EBOLAVIRUS; FEMALE; GENETIC VECTORS; HEMORRHAGIC FEVER, EBOLA; HIV INFECTIONS; HIV-1; HUMANS; INJECTIONS, INTRAMUSCULAR; MALE; MARBURG VIRUS DISEASE; MARBURGVIRUS; POLYMERASE CHAIN REACTION; RABBITS; SEROTYPING; TIME FACTORS; TISSUE DISTRIBUTION; VACCINES, DNA; VIRAL VACCINES;

ADENOVIRIDAE; ANIMALIA; HUMAN ADENOVIRUS TYPE 5; HUMAN IMMUNODEFICIENCY VIRUS 1; LAKE VICTORIA MARBURGVIRUS; ORYCTOLAGUS CUNICULUS;

EID: 53149113398     PISSN: 1547691X     EISSN: 1547691X     Source Type: Journal    
DOI: 10.1080/15376510802312464     Document Type: Article

References (24)

1. Beck, D. W., Strauss, R. G., Kisker, T., and Henriksen R. A. 1979. An Intrinsic Coagulation Pathway Inhibitor in a 3-year-old Child. AJCP 71:470-472.
2. Catanzaro, A. T., Koup, R. A., Roederer, M., Bailer, R. T., Enama, M. E., Moodie, Z., Gu, L., Martin, J. E., Novik, L., Chakrabarti, B. K., Butman, B. T., Gall, J. G., King, C. R., Andrews, C. A., Sheets, R. L., Gomez, P. L., Mascola, J. R., Nabel, G. J., Graham, B. S., and VRC006 Study Team. 2006. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J. Infect. Dis. 194:1638-1649.
3. CBER. 2006. Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications. http://www.fda.gov/cber/gdlns/reprotox.htm
4. Chang, P. Y., Roelands, J., Schindler-Horvat, J., and Sheets, R. L. 2007. Chapter 14. Toxicity Testing of Vaccines. in Nonclinical Drug Safety Assessment: Practical Considerations for Successful Registration (Sietsema, W. and Schwen, R., Eds.), Washington, DC: FDAnews, pp. 331-343.
5. Cheng, C., Gall, J. G., Kong, W. P., Sheets, R. L., Gomez, P. L., King, C. R., and Nabel, G. J. 2007. Mechanism of Ad5 vaccine immunity and toxicity: Fiber shaft targeting of dendritic cells. PLoS Pathog. 3:e25.
6. Crucell. 2006a. Press release: Crucell and AERAS Announce Start of Tuberculosis Vaccine Clinical Trial. 2006. October 25, 2006. http://investors.crucell.com/C/132631/PR/200610/1083063_5_5.html
7. Crucell. 2006b. Press release: Crucell and NIH Gain Approval and Move to Recruitment for Malaria Vaccine Clinical Study (2006). December 19, 2006. http://investors.crucell.com/C/132631/PR/200612/1094140_5_5.html
8. GenVec. 2007. Press release: First Ad35-Based HIV-1 Vaccine Enters Phase 1 Clinical Trial at NIH (2007). June 21, 2007. http://www.genvec.com/download/ press/GNVC_Ad35CLINICALTRIAL% 20Release%20_FINALOUT_062007_1.pdf
9. Graham, B. S., Koup, R. A., Roederer, M., Bailer, R. T., Enama, M. E., Moodie, Z., Martin, J. E., McCluskey M. M., Chakrabarti, B. K., Lamoreaux, L., Andrews, C. A., Gomez, P. L., Mascola, J. R., Nabel, G. J., and VRC004 Study Team 2006. Phase 1 Safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J. Infect. Dis. 194:1650-1660.
10. Harvey, B. G., Maroni, J., O'Donoghue, K. A., Chu, K. W., Muscat, J. C., Pippo, A. L., Wright, C. E., Hollmann, C., Wisnivesky, J. P., Kessler, P. D., Rasmussen, H. S., Rosengart, T. K., and Crystal, R. G. 2002. Safety of local delivery of low- and intermediate-dose adenovirus gene transfer vectors to individuals with a spectrum of morbid conditions. Hum. Gene Ther. 13:15-63.
11. Jaeger, U., Kapiotis, S., Pabinger, I., Puchhammer, E., Kyrle, P. A., and Lechner, K. 1993. Transient lupus anticoagulant associated with hypoprothrombinemia and Factor XII deficiency following adenovirus infection. Ann. Hematol. 67:95-99.
12. Lee, R. C. 1939. The rectal temperature of the normal rabbit. Am. J. Physiol. 125:521-529.
13. Malaeb, B. S., Gardner, T. A., Margulis, V., Yang, L., Gillenwater, J. Y., Chung, L. W., Macik, G., and Koeneman, K. S. 2005. Elevated activated partial thromboplastin time during administration of first-generation adenoviral vectors for gene therapy for prostate cancer: Identification of lupus anticoagulants. Urology 66:830-834.
14. Parker, A. L., Waddinton, S. N., Nicol, C. G., Shayakhmetov, D. M., Buckley, S. M., Denby, L., Kemball-Cook, G., Ni, S., Lieber, A., McVey, J. H., Nicklin, S. A., and Baker A. H. 2006. Multiple vitamin K-dependent coagulation zymogens promote adenovirus-mediated gene delivery to hepatocytes. Blood 108(8):2254-2261.
15. Raper, S. E., Yudkoff, M., Chirmule, N., Gao, G. P., Nunes, F., Haskal, Z. J., Furth, E. E., Propert, K. J., Robinson, M. B., Magosin, S., Simoes, H., Speicher, L., Hughes, J., Tazelaar, J., Wivel, N. A., Wilson, J. M., and Batshaw, M. L. 2002. A pilot study of in vivo liver-directed gene transfer with an adenoviral vector in partial ornithine transcarbamylase deficiency. Hum. Gene Ther. 13:163-175.
16. Sheets, R. L., Stein, J., Manetz, T. S., Duffy, C., Nason, M., Andrews, C., Kong, W. P., Nabel, G. J., and Gomez, P. L. 2006a. 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. Toxicol. Sci. 91:610-619.
17. Sheets, R. L., Stein, J., Manetz, T. S., Andrews, C., Bailer, R., Rathmann, J., and Gomez, P. L. 2006b. 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. Toxicol. Sci. 91:620-630.
18. 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.
19. 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.
20. Sullivan, N. J., Geisbert, T. W., Geisbert, J. B., Shedlock, D. J., Xu, L., Lamoreaux, L., Custers, J. H., Popernack, P. M., Yang, Z. Y., Pau, M. G., Roederer, M., Koup, R. A., Goudsmit, J., Jahrling, P. B., and Nabel, G. J. 2006. Immune protection of nonhuman primates against Ebola virus with single low-dose adenovirus vectors encoding modified GPs. PLoS Med. 3(6):e177.
21. Sun, Y., Schmitz, J. E., Buzby, A. P., Barker, B. R., Rao, S. S., Xu, L., Yang, Z. Y., Mascola, J. R., Nabel, G. J., and Letvin, N. L. 2006. Virus-specific cellular immune correlates of survival in vaccinated monkeys after simian immunodeficiency virus challenge. J Virol. 80:10950-10956.
22. Tatsis, N., Fitzgerald, J. C., Reyes-Sandoval, A., Harris-McCoy, K. C., Hensley, S. E., Zhou, D., Lin, S.-W., Bian, A., Xiang, Z. Q., Iparragquirre, A., Lopez-Camacho, C., Wherry, E. J., and Ertl, H. C. J. 2007. Adenoviral vectors persist in vivo and maintain activated CD8+ T cells: Implications for their use as vaccines. Blood 110:1916-1923.
23. Thorner, A. R., Lemckert, A. A. C., Goudsmit, J., Lynch, D. M., Ewald, B. A., Denholtz, M., Havenga, M. J. E., and Barouch, D. H. 2006. Immunogenicity of heterologous recombinant adenovirus prime-boost vaccine regimens is enhanced by circumventing vector cross-reactivity. J. Virol. 80:12009-12016.
24. Title 21 Code of Federal Regulations (CFR) Part 58. 2007. Good Laboratory Practices for Nonclinical Laboratory Studies.