Zika vaccines and therapeutics: landscape analysis and challenges ahead
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2018-06-01
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| Series: | BMC Medicine |
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| Online Access: | http://link.springer.com/article/10.1186/s12916-018-1067-x |
| _version_ | 1818617646155825152 |
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| author | Annelies Wilder-Smith Kirsten Vannice Anna Durbin Joachim Hombach Stephen J. Thomas Irani Thevarjan Cameron P. Simmons |
| author_facet | Annelies Wilder-Smith Kirsten Vannice Anna Durbin Joachim Hombach Stephen J. Thomas Irani Thevarjan Cameron P. Simmons |
| author_sort | Annelies Wilder-Smith |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-16T17:09:00Z |
| format | Article |
| id | doaj.art-ff6ef41735c340e6a0425d1fd46ce067 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-12-16T17:09:00Z |
| publishDate | 2018-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-ff6ef41735c340e6a0425d1fd46ce0672022-12-21T22:23:29ZengBMCBMC Medicine1741-70152018-06-0116111510.1186/s12916-018-1067-xZika vaccines and therapeutics: landscape analysis and challenges aheadAnnelies Wilder-Smith0Kirsten Vannice1Anna Durbin2Joachim Hombach3Stephen J. Thomas4Irani Thevarjan5Cameron P. Simmons6Immunization, Vaccines & Biologicals, World Health OrganizationImmunization, Vaccines & Biologicals, World Health OrganizationCenter for Immunization Research, Johns Hopkins Bloomberg School of Public HealthImmunization, Vaccines & Biologicals, World Health OrganizationState University of New York, Upstate Medical UniversityDoherty Institute for Infection and ImmunityOxford University Clinical Research UnitAbstract 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.http://link.springer.com/article/10.1186/s12916-018-1067-xZikaZika vaccinesFlavivirusAnti-viralsProphylaxisTherapeutics |
| spellingShingle | Annelies Wilder-Smith Kirsten Vannice Anna Durbin Joachim Hombach Stephen J. Thomas Irani Thevarjan Cameron P. Simmons Zika vaccines and therapeutics: landscape analysis and challenges ahead BMC Medicine Zika Zika vaccines Flavivirus Anti-virals Prophylaxis Therapeutics |
| 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 |
| topic | Zika Zika vaccines Flavivirus Anti-virals Prophylaxis Therapeutics |
| url | http://link.springer.com/article/10.1186/s12916-018-1067-x |
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