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

physIQ

Status: Unknown

Conditions: Vaccine Reaction

Study type: Observational

Funder types: Industry

Identifiers

NCT05237024

CTP-024

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

Physiology Monitoring

Description:

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

Description:

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.