Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep; Vaccine Response; Circadian Rhythm Disorders
• Intervention / Treatment: Dietary supplement: Melatonin; Device: Phillips Actiwatch Spectrum Plus

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Naval Support Activity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin Group; This group will get melatonin 5mg nightly	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
Active Comparator: Control Group; This group will not get any treatment (melatonin)	Device: Phillips Actiwatch Spectrum Plus; Both groups will be monitored by the FDA-cleared Actigraph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-influenza antibody titers	Seroconversion and titer >=1:40 post-vaccination	14-21 days post vaccination
Cell-mediated immunity	ELISpot (secretion of Interferon-gamma and Granzyme B with restimulation by influenza viral antigens), Flow cytometry to determine CD4+ and CD8+ T cell producing IFN(g) with influenza viral restimulation, and Luminex multiplex cytokine analysis in cell culture supernatant of PBMC after restimulation with influenza viral antigens.	14-21 days post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)	PSQI and vaccine immunogenicity (primary outcomes)	14-21 days post vaccination
Actigraph data	Correlation of actigraph data and vaccine immunogenicity (primary outcomes)	14-21 days post vaccination
Chronotype survey - Munich ChronoType Questionaire (MCTQ)	Correlation of MCTQ score with vaccine immunity	14-21 days post vaccination

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: Naval Medical Research Center
• Investigators: Principal Investigator: Janine Danko, MD, Naval Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Sleep; Vaccine immunogenicity; Circadian health
• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: NMRC.2021.0006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes