Guidelines for the clinical evaluation of dengue vaccines in endemic areas

Dengue vaccines are now in clinical development phases. Dengue vaccine trials represent a major given the specific epidemiology and clinical manifestations of the disease. Moreover, there are theoretical safety concerns that require a careful, stepwise approach to vaccine evaluation. The goal is to inform and propose strategies for clinical evaluation that specifically address the challenges related to dengue. The guidelines should be sufficiently detailed to discuss the scientific rationale of the proposed strategies. Experiences gained with that document may facilitate the development of global written standards for dengue vaccine development as a next step.