Use of Wearable Digital Sensors After mRNA Vaccination in Adults

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05440318

Collaborator

(none)

300

Enrollment

Locations

5.5

Anticipated Duration (Months)

37.5

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Device: Wireless wearable digital devices

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Aug 22, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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 Total Sleep Count Per 24 Hours 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CenExel	Hollywood	Florida	United States	33024
2	Meridian Clinical Research	Savannah	Georgia	United States	31406
3	Johnson County Clinical Trials	Lenexa	Kansas	United States	66219
4	Sundance Clinical Research LLC	Saint Louis	Missouri	United States	63141
5	Meridian Clinical Research	Binghamton	New York	United States	13901
6	Meridian Clinical Research	Endwell	New York	United States	13760
7	Tekton Research, Inc	Austin	Texas	United States	78745
8	Benchmark Research	Fort Worth	Texas	United States	76135

Sponsors and Collaborators

ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ModernaTX, Inc.

ClinicalTrials.gov Identifier:

NCT05440318

Other Study ID Numbers:

mRNA-CRID-002

First Posted:

Jun 30, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Study Results

No Results Posted as of Jun 30, 2022