Circadian Rhythm Disorders, Sleep, Vaccine Response
Conditions
Keywords
Sleep, Circadian health, Vaccine immunogenicity, Melatonin
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
The melatonin group will receive 5mg melatonin nightly
DEVICEPhillips Actiwatch Spectrum Plus
Both groups will be monitored by the FDA-cleared Actigraph
Sponsors
Naval Medical Research Center
Walter Reed National Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective open label melatonin compared to control
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed