(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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Vaccine Reaction

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