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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

MAVRICS Trial Summary

This trialwill look at how sleep, body clock and melatonin affect how well the flu vaccine works.

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.Check my eligibility
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.See study design
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.

MAVRICS Trial 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.

MAVRICS Trial Timeline

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)

MAVRICS 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

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
138 Previous Clinical Trials
33,338 Total Patients Enrolled
Naval Medical Research CenterFED
33 Previous Clinical Trials
2,700 Total Patients Enrolled
Janine Danko, MDPrincipal InvestigatorNaval Medical Research Center

Media Library

Melatonin Group Clinical Trial Eligibility Overview. Trial Name: NCT04953754 — N/A
Vaccine Response Research Study Groups: Melatonin Group, Control Group
Vaccine Response Clinical Trial 2023: Melatonin Group Highlights & Side Effects. Trial Name: NCT04953754 — N/A
Melatonin Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04953754 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been enlisted in this research effort?

"Affirmative. Clinicaltrials.gov asserts that this trial, which first opened on October 25th 2022, is currently recruiting participants. A total of 200 patients are needed from a single clinical site."

Answered by AI

For whom is entry into this research project open?

"This medical trial is searching for 200 individuals, aged 18 to 64 years old with circadian rhythm disturbances. It is imperative that participants are eligible to receive the flu vaccine at a military hospital and have DEERS eligibility."

Answered by AI

Is recruitment currently open for this investigation?

"Clinicaltrials.gov attests that this medical trial is open for patient enrolment, with the initial listing on October 25th 2022 and a recent update posted one day prior."

Answered by AI

Does this investigation stipulate a minimum age to participate?

"Eligibility for this trial is exclusive to those aged 18-64. For individuals under the age of 18, there are 33 different clinical trials available and 103 more options exist for patients older than 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Naval Support Activity
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Melatonin and Vaccine Response, Immunity, and Chronobiology Study
Rachel Lee 2022. "Melatonin and Vaccine Response, Immunity, and Chronobiology Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04953754.
All > Melatonin
~0 spots leftby Jun 2024
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