Guiding Vaccine Efficacy Trial Design During Public Health Emergencies: An interactive web-based decision support tool

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Corresponding author: Steven E Bellan; steve.bellan@uga.edu

Summary author: Clarissa Keisling, ceid@uga.edu

One of the most effective ways to prevent epidemics of emerging pathogens is by vaccination. However, quickly preparing effective, ethical vaccines in response to emerging diseases is difficult, as illustrated by the 2014-2016 Ebola virus and 2015-2016 Zika virus epidemics. Creating vaccines for viral pathogens is especially challenging; they have short generation times and high mutation rates, resulting in fast evolution of novel strains that can evade vaccination attempts. To address this issue, a collaborative team of researchers, working as part of the World Health Organization Research and Development Blueprint, created a web-based interactive decision support system (InterVax-Tool) to track the epidemiological, logistical, and ethical decisions involved in designing a vaccine efficacy trial during a public health emergency. This InterVax-Tool presents a cutting-edge visual and interactive guide through various “decision trees” which help the users select different parameters and considerations necessary to inform each decision in the trial design process. Another important feature of this tool is its cross-disciplinary application of trial design; it incorporates concepts from epidemiology, study design, vaccinology, biostatistics, mathematical modeling and clinical research ethics. Specifically, this article addresses the major goals and features of the InterVax-Tool, and present its application to the design of a Zika vaccine efficacy trial. The design and improvement of tools such as this is crucial for rapid and effective response to urgent public health crisis and emerging epidemics.   

Bellan, Steven E, et al. “Guiding Vaccine Efficacy Trial Design During Public Health Emergencies: An interactive web-Based decision support tool.” 2018, doi:10.1101/252783.