Use of Wearable Digital Sensors After mRNA Vaccination in Adults

Healthy Participants Clinical Trial

Official title:

Exploratory Study to Assess the Use of Wearable Digital Sensors After mRNA Vaccination in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440318
• Other study ID #: mRNA-CRID-002
• Status: Completed
• Start date: June 16, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: March 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	DM Clinical Research- Texas Center for Drug Development	Houston	Texas
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Meridian Clinical Research	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination		Baseline, up to Day 7
Primary	Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination		Baseline, up to Day 7
Primary	Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination		Baseline, up to Day 7
Primary	Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination		Baseline, up to Day 7
Primary	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
Primary	Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination		Baseline, up to Day 7