(VIII): The Eight Study and Immunologic Response Sub-study
- Conditions
- Vaccine Reaction
- Registration Number
- NCT05237024
- Lead Sponsor
- physIQ, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Is 18 years of age or older.
- Is able to speak and read English.
- Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine).
- No known prior COVID-19 infection.
Exclusion Criteria
- Known allergy to the adhesive used on the VitalPatch.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. December, 2022 Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors. December, 2022 Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. December, 2022
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
physIQ
🇺🇸Chicago, Illinois, United States
Cell Carta
🇨🇦Montréal, Quebec, Canada