Carnegie Mellon University

Design and Implementation of a Digital Vaccine Candidate for COVID-19 and its Evaluation via a Human Field Trial


Introduction

Six months ago, not many knew that SARS-COV-2 existed, and now the virus has spread globally to almost every country, infecting almost 2 million people and causing more than 115,000 deaths to date. The COVID-19 pandemic is an unprecedented and rapidly evolving disaster for people, health systems and economies worldwide. Not only has the pandemic exposed the fragilities of healthcare systems in dealing with infectious diseases, but it has also revealed the vulnerabilities of human behavior during times of crisis. As COVID-19 continues to affect every aspect of human life, a new normal is being established. Under this new normal, as scientists endeavor to build new biological vaccines for COVID19, there is increasing recognition that societies must look beyond biological methods alone to build resilience by finding new types of therapies for COVID-19 and similar infectious diseases. 

Human behavior - in particular, how people respond to the real and perceived risks of infectious diseases - is an important factor for subverting the spread of COVID-19. In fact, systematic investigations to understand the interplay between infectious disease dynamics and human behavior conclude that behavior change and disease-literacy are crucial to control the spread [1, 2]. The World Health Organization (WHO) recognizes the value of human behavior change in the management of infectious diseases, with the WHO Outbreak Communication Planning Guide suggesting that behavior changes can reduce the spread of virus by as much as 80% [3]. 

Building on our prior work on a digital solution for behavior change in the chronic disease arena, this proposal aims to: (1) design and implement a Digital Vaccine candidate, which is a scientific, multidisciplinary, evidence-based digital therapeutic intervention to induce behavior change and learning, for the containment of infectious diseases such as COVID-19; and, (2) conduct a human field trial in India to evaluate its efficacy and impact. 

What are Digital Vaccines?

Digital Vaccines are a subcategory of digital therapeutics [4], which are evidence-based prevention approaches that use digital technologies (applications delivered via smart-phones, tablets, etc.) for nudging positive human behavior via neurocognitive training. They are gamified, digital interventions that draw from principles of neuroscience, psychology, Artificial Intelligence, persuasive computing and behavioral economics to provide safe and low risk mechanisms for dynamic neuro-behavioralphysiological modulation.

A Digital Vaccine candidate for chronic diseases, Fooya!, has been developed by FriendsLearn, Inc., deployed and evaluated via pilot clinical trials in a variety of clinical, consumer, and school-based usage settings. Based on a decade of completed and ongoing research with Baylor College of Medicine, Johns Hopkins University Bloomberg School of Public Health, Carnegie Mellon University, and Stanford School of Medicine, a body promising evidence indicates that neuro-behavioral-physiological modulation through the use of Machine-Learning and Deep-Learning-enabled personalized gamified experiences may induce behavior changes and habits to reduce disease risk. Fooya! is a medical mobile application which has adopted the design principles of Digital Vaccines via a gamified learning platform that uses neuroscience, artificial intelligence and virtual reality to improve dietary choices, physical activity and health literacy amongst children. It has unique, immersive, and motivational features that encourage active-video game playing, and thereby, induce desired behavioral changes in the pediatric population [5]. 

We propose to re-purpose this platform towards containment of infectious diseases, such as COVID-19, through our knowledge and expertise related to dynamic neuro-behavioral-physiological modulation.

Digital Vaccine for COVID-19

Practicing good personal hygiene (hand washing, disinfecting surfaces, social distancing, etc.) is a critical lifestyle behavior change that could mitigate the spread of infectious diseases. We propose the use of Digital Vaccines to provide neurocognitive training to users so as to nudge them towards adopting healthhygiene practices. The Digital Vaccine will be administered via a gamified-mobile application that will be culturally sensitive and customizable.  In other words, the gamified application will entail deep levels of personalization and localization that will ensure that the vaccine meets the requirements of each target audience from all geographical, social and cultural realms. For example, for developing a COVID-19 Digital Vaccine that promotes hand-hygiene in Tamil Nadu in India, our research team will seek consultations from experts to understand the sociological, environmental, and regional norms of the area. The team will then adapt and extend the existing game design and interface components for handhygiene literacy to include local preferences that may include displaying play-instructions in the regional language, designing game avatars to resemble local appearances, using universally recognized icons in the game interfaces, and so on.

Furthermore, such dynamic content configuration embedded through engagement mechanisms proven for neurocognitive training will allow rapid deployment of the Digital Vaccine. This will be enabled by a neural network to learn and adapt based on live and forecasted streams of data. In the case of a rapidly changing virus, we need to approach containment and immunization with agility and precision that exceeds the vectors of infection. Artificial intelligence provides a system of rule based/supervised/unsupervised learning frameworks, also moderated through human intervention, that can stay ahead of an epidemic based on data. 

The Digital Vaccine for infectious diseases will be developed by FriendsLearn (https://friendslearn.com/), a decade old life science research company based in India and with an R&D office in San Francisco, that has pioneered commercially deployed Digital Vaccines in the past. Through this unique consortium of academic partners and a proven technology pioneer that can move with the agility of a startup, we propose to design, develop and evaluate, via human clinical trials, our Digital Vaccine candidate to prevent and mitigate the spread of COVID-19. The key outcomes of the trial will be tracking incidence of COVID19, time factors as well as transmission rates, and uptake of health-hygiene practices. 

References

[1] Funk, Sebastian & Salathé, Marcel & Jansen, Vincent. (2010). Modelling the Influence of Human
Behaviour on the Spread of Infectious Diseases: A Review. Journal of the Royal Society, Interface / the
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[2] Sh, Patrick & Krewski, Daniel. (2016). Reviewing the History of Pandemic Influenza: Understanding
Patterns of Emergence and Transmission. Pathogens. 5. 66. 10.3390/pathogens5040066.
[3] Outbreak Communication Planning Guide, 2008, the World Health Organization. Accessible at:
https://www.who.int/ihr/publications/outbreak-communication-guide/en/
[4] Meskó, Bertalan & Drobni, Zsofia & Bényei, Éva & Gergely, Bence & Gyorffy, Zsuzsa. (2017). Digital
health is a cultural transformation of traditional healthcare. mHealth. 3. 38-38.
10.21037/mhealth.2017.08.07.
[5] Padman, R, Kato-Lin, YC, SriPrakash, B, Gupta, S, Narang, P, Karthikeyan, P, et al. Game–based
digital vaccine for reducing risk of lifestyle diseases. Iproc. 2018; 4: e11790