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By Dixon D. O., Bland R. P.

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Proc. Natl. Acad. Sci. USA 97(2), 811–816. Smith, H. , and Klinman, D. M. (2001). The regulation of DNA vaccines. Curr. Opin. Biotechnol. 12, 299–303. Swain, W. , Wu, M. , Barr, L. , Fuller, J. , Dixon, R. , and Roy, M. J. (2000). Tolerability and immune responses in humans to a PowderJect DNA vaccine for hepatitis B. Dev. Biol. (Basel) 104, 115–119. Tacket, C. , Roy, M. , Swain, W. , and Edelman, R. (1999). Phase 1 safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by a gene delivery device.

B. Qualification of plasmid DNA product Purified plasmid DNA products should conform to the following specifications (Robertson and Griffiths, 2001; Smith and Klinman, 2001). The product should appear clear and colorless by visual inspection. The identity of the plasmid can be confirmed by nucleotide sequence, PCR for plasmid‐specific sequences and/or restriction enzyme digest patterns by gel electrophoresis. As mentioned in an earlier section, the form of the plasmid should be predominantly circular (preferably supercoiled), as judged by gel electrophoresis.

2000). m. injection. These observations suggest two basic strategies to enhance the delivery, hence potency, of DNA vaccines. First, increased distribution of the DNA vaccine within the injected tissue should allow a greater number of cells to be available for transfection. Technologies to 2. Human Clinical Trials of Plasmid DNA Vaccines 35 physically deliver DNA plasmids to tissues, such as the gene gun, needle‐free devices, electroporation, and hydrostatic pressure, result in broader expression and enhanced vaccine potency (Wells, 2004).

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A Bayes solution for the problem of ranking Poisson parameters by Dixon D. O., Bland R. P.

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