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NCT05237024 Clinical Trial

(VIII): The Eight Study and Immunologic Response Sub-study

Vaccine Reaction Clinical Trial

Official title:
Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05237024
Other study ID # CTP-024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date December 15, 2022

Study information
Verified date February 2022
Source physIQ, Inc.
Contact Maged Gendy
Phone 708-802-3797
Email maged.gendy@physiq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date December 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Cell Carta Montréal Quebec
United States physIQ Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
physIQ, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors. December, 2022
Primary Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. December, 2022
Primary Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. December, 2022
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