2009-05-30-世界卫生组织-WHO_Working_Group_on_Technical_Specifications_for_Manufacture_and_Evaluation_of_Dengue_Vaccines_36页_198kb

Dengue is a major global public health concern, endemic in over 100 countries, with an urgent need for vaccines to prevent transmission since non-specific treatments are limited. Live attenuated dengue vaccines are the primary focus of clinical development, including chimeric and recombinant approaches. The WHO guidelines for candidate tetravalent dengue vaccines will be revised to ensure quality, safety, and efficacy, incorporating new sections on environmental risk assessment, nonclinical evaluation, and clinical criteria. Key issues discussed include genetic stability of vaccines, use of cell substrates (e.g., Vero, FRhL cells), control of residual DNA, and clinical trial endpoints to assess immunogenicity and efficacy while addressing potential risks like antibody-dependent enhancement.