Doctor preparing a vaccine for an injection
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Precision medicine-focused lab services provider CellCarta and physIQ, a provider of artificial intelligence (AI) health data analytics announced the two companies will collaborate on the VIII (Vaccine-Induced Inflammation Investigation) study that will seek to monitor individual differences in physiologic changes associated with immune system activation in patients receiving vaccinations.

According to the two companies, the “Eight” study won’t take the traditional approach of studying and monitoring a vaccine’s broad response in a large population. Instead, it intends to measure individual responses of each patient’s immune system to vaccination, providing a more granular and immediate understanding of a vaccine’s effectiveness and safety.

The key technologies leveraged for this collaboration are CellCarta’s testing platform that allows comprehensive measure both humoral and cellular immune responses, combined with physIQ’s proprietary platform using FDA-cleared, AI-based analytics that can identify even the most subtle changes—within hours of vaccintation—in an individual’s own unique physiology. The companies’s stated goal is to provide the most rigorous, patient-by-patients evaluation of vaccine-induced reactogenicity and immunogenicity 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,” said Steven Steinhubl, M.D., chief medical officer of physIQ and principal investigator for the study. “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 added that the study will use 510(k)-cleared wearable biosensor that can continuously track multiple “medical-grade” physiological changes and behavioral data in near-real time. This insight should allow for the rapid correlation of physiological changes with immune response with the potential to identify adverse reactions early in order to minimize their effects.

The use of medical-grade biosensors is also a departure from some earlier studies that have used consumer wearables to monitor a patient’s vital signs after vaccination to note any changes. The companies said that the biosensors con provide unique data that can’t be collected using consumer devices.

These include:

  • Changes in physiologic variables (ECG, skin temperature, and their derivatives) from an individual’s established baseline;
  • The effect of modifications in individual routine behaviors (including multiple aspects of activity and sleep derived from accelerometers and vital signs); and
  • 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,” said Scott Sugden, Ph.D., 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”.

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