Use of Wearable Digital Sensors After mRNA Vaccination in Adults

Completed

• Conditions: Healthy Participants
• Interventions: Device: Wireless wearable digital devices

• Registration Number: NCT05440318
• Lead Sponsor: ModernaTX, Inc.

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.

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mRNA Vaccines Recipients	Wireless wearable digital devices	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.

Primary Outcome Measures

Name	Time	Method
Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination	Baseline, up to Day 7
Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination	Baseline, up to Day 7
Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination	Baseline, up to Day 7
Change From Pre-vaccination Baseline in Moderate to Vigorous Physical Activity Total Minutes Per 24 Hours up to 7 Days After Vaccination	Baseline, up to Day 7
Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination	Baseline, up to Day 7
Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination	Baseline, up to Day 7

Trial Locations

Locations (4)

Meridian Clinical Research; 🇺🇸 Lincoln, Nebraska, United States

DM Clinical Research- Texas Center for Drug Development; 🇺🇸 Houston, Texas, United States

Johnson County Clinical Trials; 🇺🇸 Lenexa, Kansas, United States

Benchmark Research; 🇺🇸 Austin, Texas, United States