Zika vaccines and therapeutics: landscape analysis and challenges ahead

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. Discussion Implementing phase 3 efficacy trials wi...

Full description

Saved in:
Bibliographic Details
Main Authors: Wilder-Smith, Annelies, Vannice, Kirsten, Durbin, Anna, Hombach, Joachim, Thomas, Stephen J., Thevarjan, Irani, Simmons, Cameron P.
Other Authors: Lee Kong Chian School of Medicine (LKCMedicine)
Format: Article
Language:English
Published: 2018
Subjects:
Online Access:https://hdl.handle.net/10356/81251
http://hdl.handle.net/10220/45067
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Nanyang Technological University
Language: English
id sg-ntu-dr.10356-81251
record_format dspace
spelling sg-ntu-dr.10356-812512020-11-01T05:21:53Z Zika vaccines and therapeutics: landscape analysis and challenges ahead Wilder-Smith, Annelies Vannice, Kirsten Durbin, Anna Hombach, Joachim Thomas, Stephen J. Thevarjan, Irani Simmons, Cameron P. Lee Kong Chian School of Medicine (LKCMedicine) Zika Vaccines Zika 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. 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. 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. Published version 2018-07-10T02:15:02Z 2019-12-06T14:26:34Z 2018-07-10T02:15:02Z 2019-12-06T14:26:34Z 2018 Journal Article Wilder-Smith, A., Vannice, K., Durbin, A., Hombach, J., Thomas, S. J., Thevarjan, I., et al. (2018). Zika vaccines and therapeutics: landscape analysis and challenges ahead. BMC Medicine, 16(1). 1741-7015 https://hdl.handle.net/10356/81251 http://hdl.handle.net/10220/45067 10.1186/s12916-018-1067-x en BMC Medicine © The Author(s). 2018 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. 15 p. application/pdf
institution Nanyang Technological University
building NTU Library
continent Asia
country Singapore
Singapore
content_provider NTU Library
collection DR-NTU
language English
topic Zika Vaccines
Zika
spellingShingle Zika Vaccines
Zika
Wilder-Smith, Annelies
Vannice, Kirsten
Durbin, Anna
Hombach, Joachim
Thomas, Stephen J.
Thevarjan, Irani
Simmons, Cameron P.
Zika vaccines and therapeutics: landscape analysis and challenges ahead
description 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. 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. 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.
author2 Lee Kong Chian School of Medicine (LKCMedicine)
author_facet Lee Kong Chian School of Medicine (LKCMedicine)
Wilder-Smith, Annelies
Vannice, Kirsten
Durbin, Anna
Hombach, Joachim
Thomas, Stephen J.
Thevarjan, Irani
Simmons, Cameron P.
format Article
author Wilder-Smith, Annelies
Vannice, Kirsten
Durbin, Anna
Hombach, Joachim
Thomas, Stephen J.
Thevarjan, Irani
Simmons, Cameron P.
author_sort Wilder-Smith, Annelies
title Zika vaccines and therapeutics: landscape analysis and challenges ahead
title_short 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_sort zika vaccines and therapeutics: landscape analysis and challenges ahead
publishDate 2018
url https://hdl.handle.net/10356/81251
http://hdl.handle.net/10220/45067
_version_ 1683493848937922560