Production and testing of dengue virus strains suitable for human infection studies.

Vaccine efficacy can be assessed in human subjects who have received dengue virus (DENV) candidate vaccines. Recent, published studies have been conducted with DENV strains that resulted in a spectrum of clinical disease. DENV-1 and DENV-3 strains were identified that could be used to test for protection against these serotypes. DENV strains that are intended for similar human clinical studies require production and preclinical testing that are the same as vaccines entering Phase 1 human clinical testing. Information on passage history, use of raw materials, testing for adventitious agents, complete characterization (including genetic sequence), and product stability are essential for DENV strain banks intended for human infection studies.
(Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.)