Clinical vaccine development

Han, Seunghoon

To meet society's need for safe and efficacious vaccines, the clinical vaccine development process has been refined for more than a century. Similar to that of chemical drugs, the clinical evaluation of a vaccine typically comprises three phases (Fig. 2) . The entire process takes 10-15 years and requires a budget of about 1 billion US dollars. A vaccine-specific developmental plan should be clearly established to ensure the efficient and successful development before clinical evaluation. This includes the following contents: 1) identification of the target population (mostly healthy people with particular demographic characteristics) and their sociocultural factors; 2) risk assessment of the target disease and the vaccine itself; 3) understanding of the incidence of the target disease and environmental factors; 4) identification of the dose and route of administration; 5) plans to induce herd immunity; and 6) regulatory strategies. The general characteristics of clinical vaccine development compared with those of conventional drug development are summarized in Table 1 .