Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS)
Primary Purpose
Vaccine Response, Sleep, Circadian Rhythm Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Phillips Actiwatch Spectrum Plus
Sponsored by
About this trial
This is an interventional other trial for Vaccine Response focused on measuring Sleep, Circadian health, Vaccine immunogenicity, Melatonin
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).
Sites / Locations
- Naval Support Activity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Melatonin Group
Control Group
Arm Description
This group will get melatonin 5mg nightly
This group will not get any treatment (melatonin)
Outcomes
Primary Outcome Measures
Anti-influenza antibody titers
Seroconversion and titer >=1:40 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.
Secondary Outcome Measures
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)
PSQI and vaccine immunogenicity (primary outcomes)
Actigraph data
Correlation of actigraph data and vaccine immunogenicity (primary outcomes)
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Correlation of MCTQ score with vaccine immunity
Full Information
NCT ID
NCT04953754
First Posted
June 4, 2021
Last Updated
October 5, 2023
Sponsor
Walter Reed National Military Medical Center
Collaborators
Naval Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04953754
Brief Title
Melatonin and Vaccine Response, Immunity, and Chronobiology Study
Acronym
MAVRICS
Official Title
Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
Naval Medical Research Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Response, Sleep, Circadian Rhythm Disorders
Keywords
Sleep, Circadian health, Vaccine immunogenicity, Melatonin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective open label melatonin compared to control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin Group
Arm Type
Experimental
Arm Description
This group will get melatonin 5mg nightly
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group will not get any treatment (melatonin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
The melatonin group will receive 5mg melatonin nightly
Intervention Type
Device
Intervention Name(s)
Phillips Actiwatch Spectrum Plus
Intervention Description
Both groups will be monitored by the FDA-cleared Actigraph
Primary Outcome Measure Information:
Title
Anti-influenza antibody titers
Description
Seroconversion and titer >=1:40 post-vaccination
Time Frame
14-21 days post vaccination
Title
Cell-mediated immunity
Description
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.
Time Frame
14-21 days post vaccination
Secondary Outcome Measure Information:
Title
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)
Description
PSQI and vaccine immunogenicity (primary outcomes)
Time Frame
14-21 days post vaccination
Title
Actigraph data
Description
Correlation of actigraph data and vaccine immunogenicity (primary outcomes)
Time Frame
14-21 days post vaccination
Title
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Description
Correlation of MCTQ score with vaccine immunity
Time Frame
14-21 days post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janine Danko, MD
Organizational Affiliation
Naval Medical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Support Activity
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Melatonin and Vaccine Response, Immunity, and Chronobiology Study
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