Vaccine development requires an amalgamation of disparate disciplines and has unique economic and regulatory drivers. Non-viral gene-based delivery systems, such as formulated plasmid
DNA, are new and potentially disruptive technologies capable of providing 'cheaper, simpler, and more convenient-to-use'
vaccines. Typically and somewhat ironically, disruptive technologies have poorer product performance, at least in the near-term, compared with the existing conventional technologies. Because successful product development requires that the product's performance must meet or exceed the efficacy threshold for a desired application, the appropriate selection of the initial product applications for a disruptive technology is critical for its successful evolution. In this regard, the near-term successes of gene-based
vaccines will likely be for protection against
bacterial toxins and acute viral and
bacterial infections. Recent breakthroughs, however, herald increasing rather than languishing performance improvements in the efficacy of gene-based
vaccines. Whether gene-based
vaccines ultimately succeed in eliciting protective immunity in humans to persistent intracellular pathogens, such as HIV,
malaria and
tuberculosis, for which the conventional
vaccine technologies have failed, remains to be determined. A success against any one of the persistent intracellular pathogens would be sufficient proof that gene-based
vaccines represent a disruptive technology against which future
vaccine technologies will be measured.