Use of Wearable Digital Sensors After mRNA Vaccination in Adults

Moderna

Status: Completed

Conditions: Healthy Participants

Treatments: Device: Wireless wearable digital devices

Study type: Observational

Funder types: Industry

Identifiers

NCT05440318

mRNA-CRID-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

62 participants in 1 patient group

mRNA Vaccines Recipients

Description:

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.

Treatment:

Device: Wireless wearable digital devices