Clinical vaccine development

Han, Seunghoon

In 'Phase II' , the 'proof-of-concept' (PoC) of the vaccine product should be ensured. Clinical trials of this phase are conducted to demonstrate the immunogenicity of the relevant active component(s) and the safety profile of a candidate vaccine within the target population and to define the optimal dose, initial schedule, and safety profile of a candidate vaccine [19] . Theses purposes are often achieved by separating clinical trials into 'Phase IIA' and 'Phase IIB. ' In designing these clinical trials, multiple variables associated with the host immune response are considered. Determinants of clinically applicable vaccine regimens are also included, such as the dose and number of doses, sequence/interval between doses, and route of administration. Vaccine efficacy may be evaluated using well-defined surrogate parameters. Most of these clinical trials include parallel group comparisons with placebo/active control groups. Prospective and confirmatory statistical analyses are performed, and the percentage of responders should be defined and described based on predefined criteria of an immune response (e.g., antibodies and/or cell-mediated immunity).