Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless wearable digital devices | Device | 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. |
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants enrolled in the multi-center, concurrent Moderna-sponsored vaccine trial will be provided the opportunity to enroll in this study. Participants will be screened for eligibility based on their concurrent enrollment in the vaccine trial.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States | ||
| Meridian Clinical Research |
Not provided
Not provided
Not provided
Not provided
| Lincoln |
| Nebraska |
| 68510 |
| United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| DM Clinical Research- Texas Center for Drug Development | Houston | Texas | 77081 | United States |