Special Issue "Developing Zika Vaccines: Status Update"

A special issue of Tropical Medicine and Infectious Disease (ISSN 2414-6366).

Deadline for manuscript submissions: closed (28 February 2019).

Special Issue Editor

Guest Editor
Prof. Stephen J Thomas

Department of Medicine, State University of New York Upstate Medical University, USA
Website | E-Mail
Interests: clinical infectious diseases; flaviviruses; vaccinology; global health

Special Issue Information

Dear Colleagues,

Zika virus was identified in the late 1940s and was a sporadic and infrequent cause of human disease until 2007 when a large clinical outbreak occurred on Yap Island. A similar event with a significant clinical attack rate occurred shortly thereafter in French Polynesia (2013). It was not until the Zika virus reached the Americas in ~2014/15 where its potential for devastating adverse neurologic and congenital outcomes was realized. The cluster of Zika virus infections in pregnant women in Brazil and adverse fetal outcomes ranging from intra-uterine death to developmental delays called the world to action to investigate the outbreak, expand our understanding of the virus, and to race to develop medical countermeasures in the form of drugs and vaccines.

The race for a Zika vaccine incorporated numerous entities to include biotech, big pharma, government, the military, non-governmental organizations, and academia. Great strides were made very quickly in the development of animal models of infection and disease, animal models of maternal-fetal infection and outcome, explorations of immunoprotective and immunopathogenic profiles, development of analytic assays, and construction of vaccine prototypes. Regulators worked closely with vaccine developers and the bioethics community to ensure volunteer vaccine recipient safety while not delaying development of vaccine candidate which may have potential for clinical benefit. Numerous phase I human studies of multiple different Zika vaccine prototypes were initiated and two candidates advanced to small scale phase II studies. It is appropriate at this time to take an inventory of progress in the development of a Zika vaccine and the questions and tasks which remain to make wide spread availability of a safe and effective product a reality.

In this Special Issue we will provide a state-of-the-art review of the Zika vaccine development field from a number of different perspectives to include; (1) epidemiology and pathophysiology of disease (Has the target population for a vaccine changed?); (2) pre-clinical development (What animal models have emerged as the most informative to support vaccine development and why and what is a brief summary of the most promising vaccine constructs in pre-clinical development?); (3) biomanufacturing (Are there unique challenges to producing Zika vaccines based on the constructs currently being tested in clinical trials); (4) clinical development (What are the unique aspects of a Zika vaccine clinical development plan in the context of the projected Target Product Profile and what is a brief summary of the constructs in clinical development?); (5) regulatory strategy (What are the most likely pathways to licensure based on the current understanding of Zika epidemiology and the possibility a traditional clinical endpoint study may not be possible?); and (6) implementation (What are the unique challenges anticipated with implementing immunization against Zika once a vaccine is available?). We request you provide your experience and expertise to the development of this Special Issue and valuable addition to the medical literature. A number of individual topic reviews have been previously published but I believe this issue will be unique because of its breath, exploration not only what we know but what we do not know, and because of your collective expertise.

Prof. Stephen J Thomas
Guest Editor

Manuscript Submission Information

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Keywords

  • Zika
  • virus
  • vaccine
  • congenital
  • Guillain-Barre
  • pre-clinical
  • clinical

Published Papers (4 papers)

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Review

Open AccessReview
Zika Vaccine Developmentā€”Current Progress and Challenges for the Future
Trop. Med. Infect. Dis. 2019, 4(3), 104; https://doi.org/10.3390/tropicalmed4030104
Received: 11 June 2019 / Revised: 3 July 2019 / Accepted: 11 July 2019 / Published: 14 July 2019
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Abstract
Zika virus is an emergent pathogen that gained significant importance during the epidemic in South and Central America as unusual and alarming complications of infection were recognized. Although initially considered a self-limited benign infection, a panoply of neurologic complications were recognized including a [...] Read more.
Zika virus is an emergent pathogen that gained significant importance during the epidemic in South and Central America as unusual and alarming complications of infection were recognized. Although initially considered a self-limited benign infection, a panoply of neurologic complications were recognized including a Guillain–Barré-like syndrome and in-utero fetal infection causing microcephaly, blindness, and other congenital neurologic complications. Numerous Zika virus vaccines were developed, with nine different vaccines representing five different platforms entered into clinical trials, one progressing to Phase II. Here we review the current landscape and challenges confronting Zika virus vaccine development. Full article
(This article belongs to the Special Issue Developing Zika Vaccines: Status Update)
Open AccessReview
Immunological Assays used to Support Efficacy of Zika Virus Vaccines
Trop. Med. Infect. Dis. 2019, 4(3), 97; https://doi.org/10.3390/tropicalmed4030097
Received: 15 May 2019 / Revised: 11 June 2019 / Accepted: 21 June 2019 / Published: 28 June 2019
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Abstract
In February of 2016, the World Health Organization (WHO) declared Zika virus (ZIKV) a Public Health Emergency of International Concern. This prompted a rapid response from both the private and public sector resulting in the generation of several promising vaccine candidates. In this [...] Read more.
In February of 2016, the World Health Organization (WHO) declared Zika virus (ZIKV) a Public Health Emergency of International Concern. This prompted a rapid response from both the private and public sector resulting in the generation of several promising vaccine candidates. In this review, we discuss published scientific efforts associated with these novel vaccines, emphasizing the immunological assays used to evaluate their immunogenicity and efficacy, and support future licensure. Full article
(This article belongs to the Special Issue Developing Zika Vaccines: Status Update)
Open AccessReview
Serologic Tools and Strategies to Support Intervention Trials to Combat Zika Virus Infection and Disease
Trop. Med. Infect. Dis. 2019, 4(2), 68; https://doi.org/10.3390/tropicalmed4020068
Received: 1 March 2019 / Revised: 11 April 2019 / Accepted: 15 April 2019 / Published: 19 April 2019
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Abstract
Zika virus is an emerging mosquito-borne flavivirus that recently caused a large epidemic in Latin America characterized by novel disease phenotypes, including Guillain-Barré syndrome, sexual transmission, and congenital anomalies, such as microcephaly. This epidemic, which was declared an international public health emergency by [...] Read more.
Zika virus is an emerging mosquito-borne flavivirus that recently caused a large epidemic in Latin America characterized by novel disease phenotypes, including Guillain-Barré syndrome, sexual transmission, and congenital anomalies, such as microcephaly. This epidemic, which was declared an international public health emergency by the World Health Organization, has highlighted shortcomings in our current understanding of, and preparation for, emerging infectious diseases in general, as well as challenges that are specific to Zika virus infection. Vaccine development for Zika virus has been a high priority of the public health response, and several candidates have shown promise in pre-clinical and early phase clinical trials. The optimal selection and implementation of imperfect serologic assays are among the crucial issues that must be addressed in order to advance Zika vaccine development. Here, I review key considerations for how best to incorporate into Zika vaccine trials the existing serologic tools, as well as those on the horizon. Beyond that, this discussion is relevant to other intervention strategies to combat Zika and likely other emerging infectious diseases. Full article
(This article belongs to the Special Issue Developing Zika Vaccines: Status Update)
Open AccessReview
Pre-Clinical Pregnancy Models for Evaluating Zika Vaccines
Trop. Med. Infect. Dis. 2019, 4(2), 58; https://doi.org/10.3390/tropicalmed4020058
Received: 28 February 2019 / Revised: 26 March 2019 / Accepted: 4 April 2019 / Published: 7 April 2019
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Abstract
Zika virus (ZIKV) infection during pregnancy can result in a variety of developmental abnormalities in the fetus, referred to as Congenital Zika Syndrome (CZS). The effects of CZS can range from the loss of the viable fetus to a variety of neurological defects [...] Read more.
Zika virus (ZIKV) infection during pregnancy can result in a variety of developmental abnormalities in the fetus, referred to as Congenital Zika Syndrome (CZS). The effects of CZS can range from the loss of the viable fetus to a variety of neurological defects in full-term infants, including microcephaly. The clinical importance of ZIKV-induced CZS has driven an intense effort to develop effective vaccines. Consequently, there are approximately 45 different ZIKV vaccine candidates at various stages of development with several undergoing phase I and II clinical trials. These vaccine candidates have been shown to effectively prevent infection in adult animal models, however, there has been less extensive testing for their ability to block vertical transmission to the fetus during pregnancy or prevent the development of CZS. In addition, it is becoming increasingly difficult to test vaccines in the field as the intensity of the ZIKV epidemic has declined precipitously, making clinical endpoint studies difficult. These ethical and practical challenges in determining efficacy of ZIKV vaccine candidates in preventing CZS have led to increased emphasis on pre-clinical testing in animal pregnancy models. Here we review the current status of pre-clinical pregnancy models for testing the ability of ZIKV vaccines to prevent CZS. Full article
(This article belongs to the Special Issue Developing Zika Vaccines: Status Update)
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