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

February 2, 2022 updated by: physIQ, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults that plan to receive COVID-19 vaccine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

physIQ, Inc.

Investigators

  • Principal Investigator: Steve Steinhubl, MD, CMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

July 15, 2022

Study Completion (Anticipated)

December 15, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CTP-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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