Abstract
We are presently aware of two early-phase DNA vaccine clinical trials in humans using electroporation-enhanced vaccine delivery. Moreover, two phase I immunogenetherapy studies are in progress and several tolerability studies have been performed on healthy volunteers. We have used knowledge from these studies to compose a template for clinical protocols involving electroporation-mediated gene delivery. In this template the emphasis will be on aspects related to electroporation. In addition, we will discuss general topics concerning electroporation-augmented DNA vaccination in human subjects.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
1. Weiner, D.B. (1995) New vaccine strategies. Mol. Med. Today. 1, 108–109.
2. Widera, G., Austin, M., Rabussay, D., et al. (2000) Increased DNA vaccine delivery and immunogenicity by electroporation in vivo. J. Immunol. 164, 4635–4640.
3. Rabussay, D., Dev, N.B., Fewell, J., Smith, L.C., Widera, G., and Zhang, L. (2003) Enhancement of therapeutic drug and DNA delivery into cells by electroporation. J. Phys. D. 36, 348–363.
4. Babiuk, S., Baca-Estrada, M.E., Foldvari, M., et al. (2003) Needle-free topical electroporation improves gene expression from plasmids administered in porcine skin. Mol. Ther. 8, 992–998.
5. Vangasseri, D.P., Han, S.J., and Huang, L. (2005) Lipid-protamine-DNA-mediated antigen delivery. Curr. Drug Deliv. 2, 401–406.
6. Spik, K., Shurtleff, A., McElroy, A.K., Guttieri, M.C., Hooper, J.W., and Schmaljohn, C. (2006) Immunogenicity of combination DNA vaccines for Rift Valley fever virus, tick-borne encephalitis virus, Hantaan virus, and Crimean Congo hemorrhagic fever virus. Vaccine. 24, 4657–4666.
7. Rompato, G., Ling, E., Chen, Z., Van, K.H., and Garmendia, A.E. (2006) Positive inductive effect of IL-2 on virus-specific cellular responses elicited by a PRRSV-ORF7 DNA vaccine in swine. Vet. Immunol. Immunopathol. 109, 151–160.
8. Ulmer, J. B., Wahren, B., and Liu, M.A. (2006) Gene-based vaccines: recent technical and clinical advances. Trends Mol. Med. 12, 216–222.
Minke, J.M., Siger, L., Karaca, K., et al. (2004) Recombinant canarypoxvirus vaccine carrying the prM/E genes of West Nile virus protects horses against a West Nile virus-mosquito challenge. Arch. Virol. Suppl. 221–230.
10. Garver, K.A., LaPatra, S.E., and Kurath, G. (2005) Efficacy of an infectious hematopoietic necrosis (IHN) virus DNA vaccine in Chinook Oncorhynchus tshawytscha and sockeye O. nerka salmon. Dis. Aquat. Organ. 64, 13–22.
11. Babiuk, S., Baca-Estrada, M., Foldvari, M., et al. (2002) Electroporation improves the efficacy of DNA vaccines in large animals. Vaccine. 20, 3399.
12. Otten, G.R., Schaefer, M., Doe, B., et al. (2006) Potent immunogenicity of an HIV-1 gag-pol fusion DNA vaccine delivered by in vivo electroporation. Vaccine. 24, 4503–4509.
13. Li, Z., Zhang, H., Fan, X., et al. (2006) DNA electroporation prime and protein boost strategy enhances humoral immunity of tuberculosis DNA vaccines in mice and non-human primates. Vaccine. 24, 4565–4568.
14. Babiuk, S., Baca-Estrada, M.E., Foldvari, M., et al. (2004) Increased gene expression and inflammatory cell infiltration caused by electroporation are both important for improving the efficacy of DNA vaccines. J. Biotechnol. 110, 1–10.
15. Heller, L., Merkler, K., Westover, J., et al. (2006) Evaluation of toxicity following electrically mediated interleukin-12 gene delivery in a B16 mouse melanoma model. Clin. Cancer Res. 12, 3177–3183.
16. Otten, G., Schaefer, M., Doe, B., et al. (2004) Enhancement of DNA vaccine potency in rhesus macaques by electroporation. Vaccine. 22, 2489–2493.
17. Draghia-Akli, R., Ellis, K.M., Hill, L.A., Malone, P.B., and Fiorotto, M.L. (2003) High-efficiency growth hormone-releasing hormone plasmid vector administration into skeletal muscle mediated by electroporation in pigs. FASEB J. 17, 526–528.
18. Wloch, M. K., Hartikka, J., Bozoukova, V., et al. (2006) Electroporation-assisted intramuscular delivery of plasmid DNA vaccines: evaluation of immunogenicity, plasmid DNA persistence and integration. The Secondary International Conference on Modern Vaccines Adjuvants and Delivery Systems, The Royal Society of Medicine, London, UK.
Kjeken, R., Tjelle, T.E., Kvale, D., and Mathiesen, I. (2004) Electroporation of skeletal muscle in humans. Executive Summaries. 7th Annual Meeting of the American Society of Gene Therapy.
20. Zhang, L. and Rabussay, D. (2005) Progress toward the development of electroporation for muscle-targeted DNA vaccines. International Symposium on Bioelectrochemistry ad Bioenergetics, Portugal, Coimbra.
21. Wang, Z., Troilo, P.J., Wang, X., et al. (2004) Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther. 11, 711–721.
Fons, M. (2006) Clinical Electroporation. Executive Summaries. 9th Annual Meeting of the Americal Society of Gene Therapy, 24.
Heller, R. (2006) Electroporation-based gene therapy in humans. Executive Summaries. 9th Annual Meeting of the Americal Society of Gene Therapy, 36.
H.Lee Moffitt Cancer and Research Institute. (2006) Phase I Trial of intratumoral pIL-12 electroporation in malignant melanoma. www.clinicaltrials.gov/ct/, NCT00323206.
Vical. (2006) A Phase I trial to evaluate the safety of intra-tumoral VCL-IM01 followed by electroporation in meatstatic melanoma. www.clinicaltrials.gov/ct/, NCT00223899.
Merck. (2006) V930 First Man (FIM) Study. www. clinicaltrials. gov/ct/, NCT00250419.
Rabussay, D., Widera, G., Zhang, L., et al. (2004) Toward the development of electroporation for delivery of DNA vaccines to humans. Executive Summaries. 7th Annual Meeting of the American Society of Gene Therapy.
28. Tjelle, T. E., Salte, R., Mathiesen, I., and Kjeken, R. (2006) A novel electroporation device for gene delivery in large animals and humans. Vaccine. 24, 4667–4670.
Southampton General Hospital. (2006). Vaccine treatment for prostate cancer that has come back (GTAC No 089). http://www. cancerhelp. org. uk/trials/.
30. Glenting, J. and Wessels, S. (2005) Ensuring safety of DNA vaccines. Microb. Cell Fact. 4, 26.
31. Poland, G.A., Borrud, A., Jacobson, R.M., et al. (1997) Determination of deltoid fat pad thickness. Implications for needle length in adult immunization. JAMA. 277, 1709–1711.
32. Estcourt, M.J., Letourneau, S., McMichael, A.J., and Hanke, T. (2005) Vaccine route, dose and type of delivery vector determine patterns of primary CD8 + T cell responses. Eur. J. Immunol. 35, 2532–2540.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2008 Humana Press
About this protocol
Cite this protocol
Tjelle, T.E., Rabussay, D., Ottensmeier, C., Mathiesen, I., Kjeken, R. (2008). Taking Electroporation-Based Delivery of DNA Vaccination into Humans: A Generic Clinical Protocol. In: Li, S. (eds) Electroporation Protocols. Methods in Molecular Biology™, vol 423. Humana Press. https://doi.org/10.1007/978-1-59745-194-9_39
Download citation
DOI: https://doi.org/10.1007/978-1-59745-194-9_39
Publisher Name: Humana Press
Print ISBN: 978-1-58829-877-5
Online ISBN: 978-1-59745-194-9
eBook Packages: Springer Protocols