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Vaccines 2018, 6(4), 70; https://doi.org/10.3390/vaccines6040070

Assay Challenges for Emerging Infectious Diseases: The Zika Experience

GeneOne Life Science, Inc., Seoul 60606, Korea
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Received: 12 September 2018 / Revised: 24 September 2018 / Accepted: 26 September 2018 / Published: 2 October 2018
(This article belongs to the Special Issue Development of Vaccines against Zika Virus)
Full-Text   |   PDF [246 KB, uploaded 2 October 2018]

Abstract

From the perspective of vaccine development, it is imperative to accurately diagnose target infections in order to exclude subjects with prior exposure from evaluations of vaccine effectiveness, to track incident infection during the course of a clinical trial and to differentiate immune reactions due to natural infections from responses that are vaccine related. When vaccine development is accelerated to a rapid pace in response to emerging infectious disease threats, the challenges to develop such diagnostic tools is even greater. This was observed through the recent expansion of Zika virus infections into the Western Hemisphere in 2014–2017. When initial Zika vaccine clinical trials were being designed and launched in response to the outbreak, there were no standardized sets of viral and immunological assays, and no approved diagnostic tests for Zika virus infection. The diagnosis of Zika virus infection is still an area of active research and development on many fronts. Here we review emerging infectious disease vaccine clinical assay development and trial execution with a special focus on the state of Zika virus clinical assays and diagnostics. View Full-Text
Keywords: emerging infectious disease; vaccines; immune response; virus detection; zika virus; flaviviruses; clinical trials emerging infectious disease; vaccines; immune response; virus detection; zika virus; flaviviruses; clinical trials
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Roberts, C.C.; Maslow, J.N. Assay Challenges for Emerging Infectious Diseases: The Zika Experience. Vaccines 2018, 6, 70.

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