MAVRICS: Melatonin and Vaccine Response, Immunity, and Chronobiology Study
Study Details
Study Description
Brief Summary
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Anti-influenza antibody titers [14-21 days post vaccination]
Seroconversion and titer >=1:40 post-vaccination
- Cell-mediated immunity [14-21 days post vaccination]
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) [14-21 days post vaccination]
PSQI and vaccine immunogenicity (primary outcomes)
- Actigraph data [14-21 days post vaccination]
Correlation of actigraph data and vaccine immunogenicity (primary outcomes)
- Chronotype survey - Munich ChronoType Questionaire (MCTQ) [14-21 days post vaccination]
Correlation of MCTQ score with vaccine immunity
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-64
-
Eligible to receive flu vaccination (at military hospital, DEERS eligible)
Exclusion Criteria:
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Allergy or contraindication to getting flu vaccine
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Pregnancy or likelihood of getting pregnant in next few weeks
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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.
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Currently taking (or recently, in past 3 months) any immune suppressants or immunomodulating treatments (systemic corticosteroids, chemotherapy, etc) or sleep medication or supplement (including over the counter medications and melatonin)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Walter Reed National Military Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WRNMMC-2021-0353