Any program aimed at the development of a vaccine should consider several important issues because they may greatly influence the choice of immunogen used in the vaccine, the delivery system selected for its application, the population to be vaccinated, and the type of vaccine to be developed (ie, preventive or therapeutic). These issues concern the epidemiology of the infectious disease targeted, the actual routes of transmission, the antigenic diversity of the infectious agent, the existing therapies, and their rate of success. In the case of hepatitis C virus, a viral agent whose clinical existence was recognized in the 1970s but which was only identified by the use of molecular cloning technology in the late 1980s, some of these issues are particularly relevant.