Recruiting

Observational Study

Sponsor:

physIQ, Inc.

Code:

NCT05237024

Conditions

Vaccine Reaction

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Vaccine Reaction

Study ID

NCT05237024

Start date

Apr 15, 2021

Status verified date

Feb, 2022

Completion date

Dec 15, 2022

Anticipated

Primary completion date

Jul 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Maged Gendy

708-802-3797maged.gendy@physiq.com

Locations

physIQ

Recruiting

Chicago, Illinois, United States, 60606

Contacts

Maged Gendy

708-802-3797maged.gendy@physiq.com

Cell Carta

Recruiting

Montréal, Quebec, Canada, H2X 3A3

Contacts

Maged Gendy

708-802-3797maged.gendy@physiq.com

More Information

Sponsor

physIQ, Inc.

Last update posted

Feb 11, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by physIQ, Inc. on 2022-02-11.