Examples of Novel Registered Prophylactic Vaccines, HPV, and JEV

Clinical development programs for vaccines can differ drastically in terms of required studies and number of study participants. Immunological correlates of protection allow down-sizing a development program substantially, since immunogenicity endpoints may be used instead of efficacy endpoints. The success of a vaccine will largely depend on its uptake in medical practice. Recommendations for the use of a vaccine are often made by expert advisory groups which are independent from the approving agency. These panels might review further factors for their decision to recommend a vaccine, such as burden of disease, feasibility of implementation, and cost-effectiveness of immunization on a population level. The present chapter presents an overview of two contrasting clinical development programs and recommendations for use for two recently registered vaccines: the Japanese Encephalitis vaccine IXIARO, a travelers’ vaccine which was licensed based on immunogenicity criteria (neutralizing antibodies), and the Human Papillomavirus Vaccine Gardasil, licensed based on efficacy in preventing precancerous lesions.