Ongoing clinical studies using electroporation-mediated DNA delivery include 2 early-phase safety efficiency studies involving intramuscular injection of a vaccine followed by electroporation. In one study first DNA vaccine delivered with electroporation in humans (sponsored by Southampton University Hospitals, UK). Also, two immune therapv studies employing IL-I2 or IL-2 genes are conducted to treat malignant melanoma, where the vaccine is injected i.t. followed by electroporation.
DNA-based vaccination has been shown to elicit significant cell mediated immune responses in several animal models; therefore, a number of efforts are being made to develop therapeutic DNA vaccines for the treatment of diseases such as chronic Hepatitis B. However, recent studies suggested that additional immune enhancement strategies are probably needed and could he very important for efficient vaccination or immunotherapy, especially when used in large animals or humans. Several studies of DNA vaccination against HER2/neu showed the effectiveness of immunization protocols in animal models of transplantable or spontaneous tumors. The DNA delivery system plays a crucial role in the success of DNA vaccination.
Non-viral gene transfer of siRNA into skeletal muscle in vivo is enhanced by electroporation to high delivery efficiencies. Electroporation consistently delivers high levels of siRNA to muscle tissue and has been used extensively for the delivery of therapeutic siRNAs to animal models, such as dystrophic mouse muscle – a mouse model of human muscular dystrophy. Electroporation was successfully used for highly efficient DNA delivery to a high proportion of fibers in treated muscles.
In vivo electroporation can he performed in a wide variety of tissues, but for DNA vaccination against infectious diseases and cancer, muscle is the most commonly used target tissue.
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