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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05237024
Enrollment
130
Registered
2022-02-11
Start date
2021-04-15
Completion date
2022-12-15
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Reaction

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.

Interventions

None listed

Sponsors

physIQ, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Canada, United States

Contacts

Primary ContactMaged Gendy
maged.gendy@physiq.com708-802-3797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026