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Public interest and concern continues to spread as the Zika virus epidemic expands. Zika virus is primarily transmitted via mosquitoes [1], and a link between Zika infection during pregnancy and microcephaly is strongly suspected, although it hasn’t been proven yet and is currently under dispute [2]. Building on lessons learned from last year’s Ebola outbreak, Zika has spurred a large and rapid response from multiple organizations and companies. In fact, a February 3rd article from Scrip reported on the quickly increasing R&D activity within this space where the number of vaccine candidates grew from one to seven within 12 short days [3]. During this same time frame, the WHO declared Zika a global public health emergency and outlined their prevention and control strategy [4], the EMA created a Zika virus task force [5], and President Obama announced plans to ask Congress for $1.8 bn to help combat Zika [6].

 

 

In response to growing interest, Citeline added Zika virus vaccines coverage to Trialtrove and Pharmaprojects so clients can quickly identify clinical trial activity to combat this public health concern. Zika is the first of a series of new diseases that are being added to Trialtrove to track the burgeoning R&D activity that followed recent outbreaks in 2015. Other patient segments to be added are Chikungunya, Ebola, and MERS (Middle East Respiratory Syndrome). But first, let’s take a look at the small, but swelling, area of Zika vaccine research.

 

 

As of February 15th, Trialtrove® and Pharmaprojects® captured 14 vaccine candidates announced by industry and non-industry groups, all of which remain in preclinical development. Figure 1 illustrates the rapid succession of vaccine announcements as well as the diversity of developers rising to the call for this unmet need. Most are currently focusing on a single vaccine candidate. The exceptions are the sole non-industry developer, National Institute of Allergy and Infectious Diseases (NIAID), and the India-based Bharat Biotech, both of whom are exploring two different vaccine approaches. NIAID’s candidates include a DNA-based vaccine and a live vaccine while Bharat pursues recombinant and inactivated vaccines.

 

 

Figure 1. Zika vaccine development timeline by announcement date and originator

 

Zika-vaccine-development

 

Source: Pharmaprojects®, Trialtrove®, February 2016

 

 

Since preclinical development for all of these pipeline Zika vaccines were only recently announced, it follows that trial activity remains limited for this area. So far, Trialtrove® has captured only two planned Phase I studies for Zika virus vaccines. It’s not surprising that one is for the first announced candidate from GeneOne Life Sciences and Inovio, which could enter clinical development by September 2016 and be available for emergency use by year end. The other planned trial is sponsored by NIAID, who stated that one of their candidates could potentially enter early phase I trials in 2016. (Data not shown)

 

 

Although the expanding pipeline appears to be promising, many unknowns remain about this virus and vaccine R&D can be a lengthy process. The fact that pregnant women are the primary target population could compound difficulties in Zika vaccine research. However, Trialtrove and Pharmaprojects will continue to track the steadily increasing R&D activity that will hopefully curtail the growth of this global health issue.

 

 

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[1] Health officials in Texas reported on a case of sexually transmitted Zika infection, and the CDC confirmed that this was the first U.S. case of Zika virus infection in a non-traveler through laboratory testing (http://www.npr.org/sections/thetwo-way/2016/02/02/465327365/zika-virus-acquired-through-sexual-transmission-officials-say).

[2] http://www.telegraph.co.uk/news/worldnews/zika/12157747/Zika-virus-Brazil-dismisses-link-between-larvicide-and-microcephaly.html

[3] http://www.scripintelligence.com/researchdevelopment/From-One-To-Six-In-12-Days-ZIKV-Vaccine-Candidates-Speed-Into-Labs-362977

[4] http://www.who.int/emergencies/zika-virus/situation-report/en/

[5] http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/02/news_detail_002466.jsp&mid=WC0b01ac058004d5c1

[6] http://www.nytimes.com/2016/02/09/us/politics/obama-congress-funding-combat-zika-virus.html?_r=0

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