Melatonin and Vaccine Response, Immunity, and Chronobiology Study

NCT ID: NCT04953754

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Melatonin Group

This group will get melatonin 5mg nightly

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

The melatonin group will receive 5mg melatonin nightly

Phillips Actiwatch Spectrum Plus

Intervention Type: DEVICE

Both groups will be monitored by the FDA-cleared Actigraph

Control Group

This group will not get any treatment (melatonin)

Group Type: ACTIVE_COMPARATOR

Phillips Actiwatch Spectrum Plus

Intervention Type: DEVICE

Both groups will be monitored by the FDA-cleared Actigraph

Interventions

Melatonin

The melatonin group will receive 5mg melatonin nightly

Intervention Type: DIETARY_SUPPLEMENT

Phillips Actiwatch Spectrum Plus

Both groups will be monitored by the FDA-cleared Actigraph

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18-64
• Eligible to receive flu vaccination (at military hospital, DEERS eligible)

Exclusion Criteria

• Allergy or contraindication to getting flu vaccine
• Pregnancy or likelihood of getting pregnant in next few weeks
• Medical history of doctor diagnosed immune-compromising condition (HIV/AIDS, cancer, diabetes, significant cardiovascular disease) or doctor diagnosed sleep disorder (insomnia, narcolepsy).*Sleep apnea is an exclusion unless stable on treatment with cpap or oral device for more than3 months.
• Currently taking any immune suppressants or immunomodulating treatments (systemic corticosteroids, chemotherapy, etc, within the past 3 months) or sleep medication or supplement (including over the counter medications and melatonin, within the past 1 month).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naval Medical Research Center

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Rachel Lee

Service Chief, Allergy, Immunology & Immunizations

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janine Danko, MD

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Research Center

Locations

Naval Support Activity

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NMRC.2021.0006

Identifier Type: -

Identifier Source: org_study_id