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The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiology Monitoring | The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. | ||
| Physiology & Immune Monitoring | A limited sub-study including 30 individuals enrolled in the primary study (not retrospective group) will incorporate serial blood draws relative to the vaccine doses. The purpose of the serologies and immunoassays is to explore the correlation an individual's development of a vaccine-induced immune response with changes in the continuous physiologic data surrounding the immunization process. |
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| Measure | Description | Time Frame |
|---|---|---|
| Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors. | December, 2022 | |
| Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. | December, 2022 | |
| Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. | December, 2022 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults that plan to receive COVID-19 vaccine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maged Gendy | Contact | 708-802-3797 | maged.gendy@physiq.com |
| Name | Affiliation | Role |
|---|---|---|
| Steve Steinhubl, MD | CMO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| physIQ | Recruiting | Chicago | Illinois | 60606 | United States |
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| Cell Carta | Recruiting | Montreal | Quebec | H2X 3A3 | Canada |
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