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

NCT05237024 | Unknown

• 1 other identifier: CTP-024
• Study Type: observational
• Target: 130
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.

  December, 2022

• Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants.

  December, 2022

• Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.

  December, 2022

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults that plan to receive COVID-19 vaccine.

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the adhesive used on the VitalPatch.

Sponsors & Collaborators

• physIQ, Inc.: lead

Study Sites (2)

physIQ

Chicago, Illinois, 60606, United States

RECRUITING

Cell Carta

Montreal, Quebec, H2X 3A3, Canada

RECRUITING

Study Officials

• Steve Steinhubl, MD

  CMO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maged Gendy

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 11, 2022
• Study Start: April 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)