Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Vaccine Reaction
- Sponsor
- physIQ, Inc.
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.
Time Frame: December, 2022
Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants.
Time Frame: December, 2022
Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.
Time Frame: December, 2022