Moderna is conducting a clinical trial on a wireless wearable digital device to explore the physiological & behavioral impact of the immune response to an mRNA jab.

Jan 10 2023

Use of Wearable Digital Sensors After mRNA Vaccination in Adults

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 
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

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Study Type  : Observational
Estimated 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  : June 16, 2022
Estimated Primary Completion Date  : April 7, 2023
Estimated Study Completion Date  : July 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

U.S. FDA Resources

Groups and Cohorts

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Group/Cohort  Intervention/treatment 
mRNA Vaccines RecipientsParticipants 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 devicesWireless 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

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Primary Outcome Measures  :

  1. Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination [ Time Frame: Baseline, up to Day 7 ]
  2. Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination [ Time Frame: Baseline, up to Day 7 ]
  3. Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination [ Time Frame: Baseline, up to Day 7 ]
  4. 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 ]
  5. 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 ]
  6. 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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