Use of Wearable Digital Sensors After mRNA Vaccination in Adults

NCT ID: NCT05440318

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2023-02-07

Brief Summary

The purpose of this study is to explore the physiological and behavioral impact of the immune response to vaccines after receipt of investigational or approved messenger ribonucleic acid (mRNA) vaccines using wearable medical sensors, with the potential of establishing a digital biomarker of vaccine response due to stimulation of the immune system.

Detailed Description

Participants will be provided wearable medical sensor equipment and instructions at the start of the study. Participants will have access to device support throughout the study period. The wireless medical devices will be applied prior to vaccination in the concurrent Moderna-sponsored vaccine trial in order to establish an initial baseline of participants' daily physiological patterns.

Conditions

Healthy Participants

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mRNA Vaccines Recipients

Participants will wear 2 devices during the specified monitoring period. They will wear both a small patch on their chest that captures continuous electrocardiogram (ECG), accelerometry, and temperature data, and a modified smartwatch measuring continuous photoplethysmography (PPG) and accelerometry data.

Wireless wearable digital devices

Intervention Type: DEVICE

Wireless wearable digital devices (including a small patch, modified watch, and datahub smartphone with electronic Patient Reported Outcomes \[ePRO\] capability) will be provided to each participant enrolled in the study.

Interventions

Wireless wearable digital devices

Wireless wearable digital devices (including a small patch, modified watch, and datahub smartphone with electronic Patient Reported Outcomes \[ePRO\] capability) will be provided to each participant enrolled in the study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Enrolled in a concurrent Moderna-sponsored vaccine clinical trial.
• Investigator assessment that participant understands and is willing and physically able to comply with wearing the sensors and follow-up as outlined in the study protocol, including all procedures.
• Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in the study protocol.

Exclusion Criteria

• History of hypersensitivity or allergic reaction to medical adhesive or other history of skin irritation, that, in the opinion of the investigator, contraindicates their use of a wearable medical device.
• Broken skin at the site of wearable location
• Implanted, permanent pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johnson County Clinical Trials

Lenexa, Kansas, United States

Meridian Clinical Research

Lincoln, Nebraska, United States

Benchmark Research

Austin, Texas, United States

DM Clinical Research- Texas Center for Drug Development

Houston, Texas, United States

Countries

United States

Other Identifiers

mRNA-CRID-002

Identifier Type: -

Identifier Source: org_study_id