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| Name | Class |
|---|---|
| Naval Medical Research Center | FED |
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This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Group | Experimental | This group will get melatonin 5mg nightly |
|
| Control Group | Active Comparator | This group will not get any treatment (melatonin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | The melatonin group will receive 5mg melatonin nightly |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janine Danko, MD | Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Support Activity | Bethesda | Maryland | 20889 | United States |
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| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Prospective open label melatonin compared to control
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| Phillips Actiwatch Spectrum Plus |
| Device |
Both groups will be monitored by the FDA-cleared Actigraph |
|
| 14-21 days post vaccination |
| Chronotype survey - Munich ChronoType Questionaire (MCTQ) | Correlation of MCTQ score with vaccine immunity | 14-21 days post vaccination |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |