NCT04953754

Melatonin and Vaccine Response, Immunity, and Chronobiology Study

Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

Detailed description

Vaccination is critical to public health and disease prevention. However, despite the many scientific advancements and vaccines on the market, they are not always fully effective. Adjuvants are often used to boost immunity, but they are associated with more side effects, possible allergic reactions and public mistrust that supports vaccine hesitancy. Many factors affect vaccine efficacy and host immunity. Sleep, circadian health and melatonin have been studied in the past to affect immune response to vaccines and infection. Patient education about better sleep habits and/or melatonin use are potentially safe, cost effective, and accessible interventions that may improve host immunity and vaccine effectiveness. However, neither have been studied rigorously and at this time, are not actively implemented in the clinical arena. Hence, we propose a study comparing vaccine immunogenicity based on sleep quality, chronotype, and exogenous melatonin.

Conditions

• Vaccine Response
• Sleep
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	The melatonin group will receive 5mg melatonin nightly
DEVICE	Phillips Actiwatch Spectrum Plus	Both groups will be monitored by the FDA-cleared Actigraph

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2021-07-08
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study