What side effects are associated with this type of intervention?

Melatonin, commonly used to regulate circadian rhythms and improve sleep, is generally well tolerated with few serious adverse effects. Common side effects include dizziness, daytime drowsiness, and headaches. Long-term safety data are limited, and as a dietary supplement, melatonin is not subject to the same regulatory standards as over-the-counter or prescription drugs.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for treatments directly targeting vaccine response using melatonin or similar agents that regulate circadian rhythms and immune function. However, melatonin has been studied for its immunomodulatory properties and its potential to enhance vaccine efficacy by regulating circadian rhythms. Further research is needed to establish its role and obtain FDA approval for such applications.

What other types of research exist?

Promising alternatives to melatonin for regulating circadian rhythms and immune function in vaccine response patients include light therapy, which has been shown to impact sleep and circadian phase, and DNA-based vaccines, which have demonstrated robust immune responses in preclinical models. Additionally, the use of biologics and immune modulators, such as anti-IgE monoclonal antibodies, may offer novel approaches to enhancing vaccine efficacy.

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Melatonin for Vaccine Response (MAVRICS Trial)

N/A

Waitlist Available

Led By Janine Danko, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-64

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14-21 days post vaccination

Awards & highlights

Summary

This trial will study if better sleep habits, understanding natural sleep cycles, and taking melatonin can help make the flu vaccine work better for people.

Who is the study for?

This trial is for adults aged 18-64 who can get a flu shot at a military hospital and are registered in the DEERS system. It's not for those with allergies to the flu vaccine, pregnant women, or individuals with immune-compromising conditions like HIV/AIDS, cancer, diabetes, significant heart disease or diagnosed sleep disorders.

What is being tested?

The study is looking into how sleep patterns and melatonin (a natural hormone) affect the body's response to the flu vaccine. Participants will be monitored using a Phillips Actiwatch Spectrum Plus device to track their sleep and activity rhythms.

What are the potential side effects?

Since this trial involves taking melatonin and receiving a standard flu vaccine, potential side effects may include drowsiness from melatonin and common mild reactions to vaccines such as soreness at injection site, fever or muscle aches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14-21 days post vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14-21 days post vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-21 days post vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anti-influenza antibody titers

Cell-mediated immunity

Secondary outcome measures

Actigraph data

Chronotype survey - Munich ChronoType Questionaire (MCTQ)

Sleep survey - Pittsburgh Sleep Quality Index (PSQI)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Melatonin GroupExperimental Treatment2 Interventions

This group will get melatonin 5mg nightly

Group II: Control GroupActive Control1 Intervention

This group will not get any treatment (melatonin)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melatonin, a hormone produced in the pineal gland, regulates circadian rhythms and has antioxidant, anti-inflammatory, and immunomodulating properties. These mechanisms can enhance the body's immune response, which is crucial for vaccine efficacy. By improving sleep quality and aligning circadian rhythms, melatonin may optimize the timing and effectiveness of immune responses, potentially leading to better vaccine outcomes.

Sustained melatonin treatment blocks body mass, pelage, reproductive, and fever responses to short day lengths in female Siberian hamsters.