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OpenTrials
Completed

NCT Number: NCT05440318

Use of Wearable Digital Sensors After mRNA Vaccination in Adults

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johnson County Clinical Trials, Lenexa, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Exploratory Study to Assess the Use of Wearable Digital Sensors After mRNA Vaccination in Healthy Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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