Zika vaccines and therapeutics: landscape analysis and challenges ahead

<p>Background: Various Zika virus (ZIKV) vaccine candidates are currently in development. Nevertheless, unique challenges in clinical development and regulatory pathways may hinder the licensure of high-quality, safe, and effective ZIKV vaccines.</p><p> Discussion: Implementing ph...

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Main Authors: Wilder-Smith, A, Vannice, K, Durbin, A, Hombach, J, Thomas, S, Thevarjan, I, Simmons, C
Format: Journal article
Language:English
Published: BioMed Central 2018
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author Wilder-Smith, A
Vannice, K
Durbin, A
Hombach, J
Thomas, S
Thevarjan, I
Simmons, C
author_facet Wilder-Smith, A
Vannice, K
Durbin, A
Hombach, J
Thomas, S
Thevarjan, I
Simmons, C
author_sort Wilder-Smith, A
collection OXFORD
description <p>Background: Various Zika virus (ZIKV) vaccine candidates are currently in development. Nevertheless, unique challenges in clinical development and regulatory pathways may hinder the licensure of high-quality, safe, and effective ZIKV vaccines.</p><p> Discussion: Implementing phase 3 efficacy trials will be difficult given the challenges of the spatio-temporal heterogeneity of ZIKV transmission, the unpredictability of ZIKV epidemics, the broad spectrum of clinical manifestations making a single definite endpoint difficult, a lack of sensitive and specific diagnostic assays, and the need for inclusion of vulnerable target populations. In addition to a vaccine, drugs for primary prophylaxis, post-exposure prophylaxis, or treatment should also be developed to prevent or mitigate the severity of congenital Zika syndrome.</p><p> Conclusion: Establishing the feasibility of immune correlates and/or surrogates are a priority. Given the challenges in conducting phase 3 trials at a time of waning incidence, human challenge trials should be considered to evaluate efficacy. Continued financial support and engagement of industry partners will be essential to the successful development, licensure, and accessibility of Zika vaccines or therapeutics.</p>
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spelling oxford-uuid:8d4606e5-e58d-4355-886c-118802cf255a2022-03-26T22:50:16ZZika vaccines and therapeutics: landscape analysis and challenges aheadJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8d4606e5-e58d-4355-886c-118802cf255aEnglishSymplectic Elements at OxfordBioMed Central2018Wilder-Smith, AVannice, KDurbin, AHombach, JThomas, SThevarjan, ISimmons, C<p>Background: Various Zika virus (ZIKV) vaccine candidates are currently in development. Nevertheless, unique challenges in clinical development and regulatory pathways may hinder the licensure of high-quality, safe, and effective ZIKV vaccines.</p><p> Discussion: Implementing phase 3 efficacy trials will be difficult given the challenges of the spatio-temporal heterogeneity of ZIKV transmission, the unpredictability of ZIKV epidemics, the broad spectrum of clinical manifestations making a single definite endpoint difficult, a lack of sensitive and specific diagnostic assays, and the need for inclusion of vulnerable target populations. In addition to a vaccine, drugs for primary prophylaxis, post-exposure prophylaxis, or treatment should also be developed to prevent or mitigate the severity of congenital Zika syndrome.</p><p> Conclusion: Establishing the feasibility of immune correlates and/or surrogates are a priority. Given the challenges in conducting phase 3 trials at a time of waning incidence, human challenge trials should be considered to evaluate efficacy. Continued financial support and engagement of industry partners will be essential to the successful development, licensure, and accessibility of Zika vaccines or therapeutics.</p>
spellingShingle Wilder-Smith, A
Vannice, K
Durbin, A
Hombach, J
Thomas, S
Thevarjan, I
Simmons, C
Zika vaccines and therapeutics: landscape analysis and challenges ahead
title Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_full Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_fullStr Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_full_unstemmed Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_short Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_sort zika vaccines and therapeutics landscape analysis and challenges ahead
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