Vaccines gene-based

T.W. Dubensky M.A. Liu and J.B. Ulmer, Delivery systems for gene-based vaccines,... 

Barouch D H (2006). Rational design of gene-based vaccines. 7. Pathol. 208 283-289. 

Peptoids have also shown great utility in their ability to complex with and deliver nucleic acids to cells, a critical step toward the development of antisense drugs, DNA vaccines, or gene-based therapeutics. Most non-viral nucleic acid delivery systems are based on cationic molecules that can form complexes with the polyan-... 

An additional consideration that may influence the protocol used is the desired duration of subsequent expression of the gene product. In most cases of genetic disease, long-term expression of the inserted gene would be required. In other instances (e.g. some forms of cancer therapy or the use of gene therapy to deliver a DNA-based vaccine), short-term expression of the gene introduced would be sufficient/desirable. 

J. Kuball, M. Schnler, E. Antunes-Ferreira, W. Herr, M. Neumann, E. Obenaner-Kntner, E. Westreich, C. Huber, T. Wolfel, and M. Theobald, Generating p53-specific cytotoxic T lymphocytes by recombinant adenoviral vector based vaccination in mice bnt not man. Gene Therapy, 833-843 (2002). 

Bramson, J., et al. 2003. Enabling topical immunization via microporation A novel method for pain-free and needle-free delivery of adenovirus-based vaccines. Gene Ther 10 251. 

The definition of a process based on biotechnology is sufficiently broad to capture a wide arrange of medicinal products, such as recombinant proteins and gene-based therapeutics, and prophylactics, such as gene transfer medicinal products and DNA vaccines. Medicinal products manufactured by biotechnological processes as defined in the Annex to Regulation (EC) 726/2004 must be authorized centrally pursuant to article 3 of the Regulation. 

Viral vector and cell-based vaccines FDA guidance for industry guidance for human somatic cell therapy and gene therapy 1998... 

Basak SK, Kiertscher SM, Harui A, Roth MD. Modifying adenoviral vectors for use as gene-based cancer vaccines. Viral Immunol 2004 17 182-96. 

Tan, Y., Hackett, N.R., Boyer, J.L., Crystal, D.G. (2003). Protective immunity evoked against anthrax lethal toxin after a single intramuscular administration of an adenovirus-based vaccine encoding humanized protective antigen. Hum. Gene Ther. 14 1673-82. 

Transdermal vaccination or transcutaneous immunization, is attractive, because it does not require specially trained personnel necessary for needle injections. Topical application of antigens to intact skin has shown promising results for the administration of DNA-based vaccines. Noninvasive gene delivery by pipetting adenovirus- or liposome-complexed plasmid DNA onto the outer layer of skin was able to achieve localized transgene expression within a restricted subset of skin in mice. It also elicited an immune response against the protein encoded by the DNA. ... 

Tlie development of validated manufacturing processes is a prerequisite for pharmaceutical application of the newer biotechnologicals, such as DNA for plasmid-based genes in vaccines and gene therapy. Using bioprocess-design information it is possible to create efficient and consistent processes for these materials. Key issues are the required piu ity, the sensitivity of the chromosomal DNA and larger plasmids to hydrodynamic forces, and the impact of the various characteristics of plasmids on the recovery and purification of DNA for pharmaceutical purposes. " " ... 

The major target indications of biopharmaceuticals currently undergoing clinical trials include cancer, cardiovascular, and infectious diseases, the major killers within the developed world. Although in excess of 30 nucleic acid-based drugs are currently being evaluated for gene therapy, vaccines, and other applications, the majority remain in the early stages of clinical development (phase I/II) [11]. 

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