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Zika vaccines and therapeutics: landscape analysis and challenges ahead
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Immunization, Vaccines & Biologicals, World Health Organization, Geneva, Switzerland; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
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2018 (English)In: BMC Medicine, ISSN 1741-7015, E-ISSN 1741-7015, Vol. 16, article id 84Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BioMed Central, 2018. Vol. 16, article id 84
Keywords [en]
Anti-virals, Clinical endpoints, Efficacy trials, Flavivirus, Human controlled infections, Immune correlates, Immune surrogates, Monoclonal antibodies, Prophylaxis, Therapeutics, Zika, Zika diagnostics, Zika vaccines
National Category
Infectious Medicine
Identifiers
URN: urn:nbn:se:umu:diva-150619DOI: 10.1186/s12916-018-1067-xISI: 000435012000001PubMedID: 29871628Scopus ID: 2-s2.0-85048075716OAI: oai:DiVA.org:umu-150619DiVA, id: diva2:1238773
Available from: 2018-08-14 Created: 2018-08-14 Last updated: 2018-08-16Bibliographically approved

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