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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
The melatonin group will receive 5mg melatonin nightly
Both groups will be monitored by the FDA-cleared Actigraph
Naval Support Activity
Bethesda, Maryland, United States
Anti-influenza antibody titers
Seroconversion and titer \>=1:40 post-vaccination
Time frame: 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.
Time frame: 14-21 days post vaccination
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)
PSQI and vaccine immunogenicity (primary outcomes)
Time frame: 14-21 days post vaccination
Actigraph data
Correlation of actigraph data and vaccine immunogenicity (primary outcomes)
Time frame: 14-21 days post vaccination
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Correlation of MCTQ score with vaccine immunity
Time frame: 14-21 days post vaccination
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