Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004
Hombach, J.; Solomon, T.; Kurane, I.; Jacobson, J.; Wood, D.
Vaccine 23(45): 5205-5211
2005
ISSN/ISBN: 0264-410X PMID: 16055233 DOI: 10.1016/j.vaccine.2005.07.002Document Number: 217292
The World Health Organization (WHO) is undertaking consultations on immune 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 are 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.
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