Virological confirmation of suspected dengue in a Phase 2 Latin American vaccine trial: Implications for vaccine efficacy evaluation

Mark J. Boaz,Helene Janosczyk,S. Garg,S. Yost,S. Hildreth,G. Dayan,L. Starr-spires

Published 2014 in Trials in Vaccinology

ABSTRACT

The CYD tetravalent dengue vaccine candidate is being evaluated for protective efficacy against symptomatic dengue in Phase 3 efficacy trials. The laboratory test algorithm to confirm dengue cases was evaluated prior to Phase 3 trials. During a Phase 2 trial in Latin America a dengue epidemic occurred in the study countries. A total of 72 suspected dengue cases were reported and assessed: virological confirmation comprised qRT-PCR methods and a commercial ELISA kit for NS1 protein (Bio-Rad). The qRT-PCR included a screening assay targeting a conserved dengue region of the 3

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