title: Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004.
abstract: The World Health Organization (WHO) is undertaking consultations on immunological responses as parameters for evaluation and licensure of new Japanese encephalitis (JE) vaccines. Immunological markers could be used by vaccine developers and regulatory authorities to assess vaccine efficacy in absence of clinical efficacy data. The consultation which is reported here reviewed current data on mechanisms of protective immunity gathered from animal experimentation, clinical data from licensed vaccines and from vaccine candidates still in clinical development. Immunological assays and readouts for use in evaluation of candidate vaccines were also discussed. The consultation made a series of recommendations for specifications on immunological criteria to assess JE vaccine efficacy. More detailed recommendations will be drafted following further consultations to serve as WHO guidelines for evaluation and licensure for new JE vaccines.
authors.affiliation: Immunization, Vaccines and Biologicals, World Health Organization, 20, Geneva 27, Switzerland. hombachj@who.int
authors.forename: Joachim
authors.initials: J
authors.lastname: Hombach
authors.forename: Tom
authors.initials: T
authors.lastname: Solomon
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kurane
authors.forename: Julie
authors.initials: J
authors.lastname: Jacobson
authors.forename: David
authors.initials: D
authors.lastname: Wood
mesh_terms: D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D001681:Biological Assay; D004672:Encephalitis, Japanese / Q000276:immunology / Q000517:prevention & control; D023381:Endpoint Determination; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D007883:Legislation, Medical; D011634:Public Health; D014944:World Health Organization
chemical_list: D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines