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.
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 Type
OBSERVATIONAL
Enrollment
62
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.
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
Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination
Time frame: 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
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
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