CHICAGO– physIQ, a pioneer in digital medicine, and CellCarta, a global leader in precision medicine services, announce a strategic collaboration to undertake a groundbreaking study with the potential to revolutionize vaccine development.
With enrollment now complete, The VIII (Vaccine-Induced Inflammation Investigation) Study: The “Eight” Study and its Immunologic Response Sub-study seeks to monitor individual differences in physiologic changes associated with immune system activation in patients receiving vaccinations, including those developed to combat diseases such as COVID-19. The study will use blood samples and medical-grade biosensors to continuously monitor and capture remote patient physiology data 24/7. It is made possible through CellCarta’s unique capabilities to comprehensively measure both humoral and cellular immune responses and physIQ’s proprietary platform using FDA-cleared, AI-based analytics to identify even the most subtle changes in an individual’s own unique physiology. Such changes in physiology and behavior can be detected within hours after a vaccine is administered and can be correlated to long-lasting immune responses.
Moving well beyond the traditional approach of testing a vaccine’s collective response in large populations, this precision approach can identify how an individual’s own immune system responds to a vaccine, offering an unprecedented opportunity to measure vaccine safety and effectiveness. The VII study is anticipated to provide the most rigorous, detailed evaluation of vaccine-induced reactogenicity (capacity of a vaccine to produce common, expected adverse reactions) and immunogenicity (the ability of cells/tissues to provoke an immune response) to date.
“Until now, there has never been a study that has looked so closely at individual differences in immune response to vaccines and their relationship to physiologic changes. Our goal is to provide tools that help accelerate the therapeutic development of personalized vaccine regimens by looking at the full immune response. This is important because we know there are unique differences in how people react to all vaccines,” said Steven Steinhubl, MD, physIQ Chief Medical Officer and principal investigator for the study. “By using highly reliable, 510(k)-cleared wearable biosensors instead of consumer devices, we’re able to continuously track multiple medical-grade physiological and behavioral metrics collected during activities of daily living. This near real-time capture of patient data potentially allows us to rapidly correlate physiological changes to immune responses and minimize possible adverse reactions early.”
While earlier studies have shown that consumer wearables can monitor changes in people’s vital signs after vaccination, using medical-grade biosensors to measure vaccine-induced immune activation and subsequent inflammation assesses three distinct types of metrics: 1.) changes in physiologic variables (ECG, skin temperature and their derivatives) from that individual person’s established baseline; 2.) effect of modifications in individual routine behaviors (including multiple aspects of activity and sleep derived from accelerometers and vital signs); and, 3.) the interactions between these variables and how they deviate from that individual’s expected results.
“We are excited to generate new potential insights into what makes a successful vaccination at the individual level,” says Dr. Scott Sugden, Immunologist and Principal Investigator of the study at CellCarta. “By evaluating the correlation between immediate physiological responses, antibody production and cellular immunity, the project will seek to define potential new metrics for rapid assessment of successful vaccination, which could ultimately lead to more effective vaccination strategies for everyone, including the most vulnerable, at-risk populations”.
