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Use of Wearable Digital Sensors After mRNA Vaccination in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05440318
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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.

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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 : August 22, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Group/Cohort Intervention/treatment
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.
Device: Wireless wearable digital devices
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 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05440318


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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United States, Florida
CenExel Recruiting
Hollywood, Florida, United States, 33024
United States, Georgia
Meridian Clinical Research Recruiting
Savannah, Georgia, United States, 31406
United States, Kansas
Johnson County Clinical Trials Recruiting
Lenexa, Kansas, United States, 66219
United States, Missouri
Sundance Clinical Research LLC Not yet recruiting
Saint Louis, Missouri, United States, 63141
United States, New York
Meridian Clinical Research Not yet recruiting
Binghamton, New York, United States, 13901
Meridian Clinical Research Not yet recruiting
Endwell, New York, United States, 13760
United States, Texas
Tekton Research, Inc Not yet recruiting
Austin, Texas, United States, 78745
Benchmark Research Not yet recruiting
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05440318    
Other Study ID Numbers: mRNA-CRID-002
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022