Clinical trial NCT05440318: Use of Wearable Digital Sensors After mRNA Vaccination in Adults
Official title: Exploratory Study to Assess the Use of Wearable Digital Sensors After mRNA Vaccination in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Participants
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
measure: Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
measure: Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
measure: Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
measure: Change From Pre-vaccination Baseline in Moderate to Vigorous Physical Activity Total Minutes Per 24 Hours up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
measure: Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination
timeFrame: Baseline, up to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- Texas Center for Drug Development
state: Texas
Study officials:
References: