Healthy Participants
Conditions
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.
Interventions
DEVICEWireless 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.
Sponsors
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed