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Trial Assessing Digital Data for Covid-19 Vaccine Responses

Syringe in hand

(Sam Moqadam, Unsplash)

17 Mar. 2022. A clinical trial is evaluating data gleaned from wearable devices for measuring individual physiological reactions to Covid-19 vaccines. The trial’s sponsor, physIQ in Chicago, says enrollment is now complete for the study, conducted with contract research organization CellCarta in Montreal, Quebec, Canada.

The trial seeks to track immune system reactions by individuals receiving Covid-19 vaccines, with a combination of digital data captured by wearable devices and blood tests. physIQ generates health care analytics from biosensor data captured continuously with wearable devices including smart watches. The company says its analytics use machine learning algorithms that capture an individual’s vital signs from wearables, then provide a personalized report based on data from that person.

Food and Drug Administration, says physIQ, cleared the company’s remote monitoring algorithm to improve the accuracy of its assessments, as well as the company’s cloud-based analytics for heart rate, heart rate variability, atrial fibrillation detection, respiration rate, and personalized physiology change detection. Since the start of the Covid-19 pandemic, physIQ says it turned its capabilities to remote patient monitoring to help develop new vaccines and treatments. Science & Enterprise reported in May 2021 on an NIH-funded evaluation of the company’s health analytics to track physiological markers making up an index of clinical decomposition, as an early indicator of health decline.

Correlate physiological reactions to immune responses

CellCarta is a contract research organization specializing in precision medicine studies tracking biomarkers, or molecular indicators, of disease in individuals. The company says it can monitor genomics and analyze tissue samples worldwide, as well as provide detailed analytics of immune responses by clinical trial participants, including antibody and T-cell production.

The clinical trial is enrolling 130 adults and children in Chicago and Montreal not yet vaccinated against the SARS-CoV-2 virus, but with plans to receive a vaccine. Participants will provide health data from wearable devices such as heart rate and skin temperature, as well as measures of sleep and activity, before and after vaccination. In addition, about 30 participants will provide blood samples before and after vaccination to measure production of antibodies and T-cells in their immune responses to the vaccines.

The study team plans to correlate data from wearable devices to blood samples to find associations between vaccine-induced reactions, including adverse effects, to immune responses.Those data include detailed measures of physiological indicators, such as heart rate and skin temperature from before to after vaccination, changes in individual activity and sleep routines, and interactions of these data as well as deviations from expected results.

“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,” says Steven Steinhubl, physIQ’s chief medical officer in a statement. “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.” Steinhubl, the study’s lead investigator, adds, “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.”

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