Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Anti-influenza antibody titers
研究概览
简要总结
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-64
- •Eligible to receive flu vaccination (at military hospital, DEERS eligible)
排除标准
- •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).
结局指标
主要结局
Anti-influenza antibody titers
时间窗: 14-21 days post vaccination
Seroconversion and titer \>=1:40 post-vaccination
Cell-mediated immunity
时间窗: 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.
次要结局
- Actigraph data(14-21 days post vaccination)
- Sleep survey - Pittsburgh Sleep Quality Index (PSQI)(14-21 days post vaccination)
- Chronotype survey - Munich ChronoType Questionaire (MCTQ)(14-21 days post vaccination)
研究者
Rachel Lee
Service Chief, Allergy, Immunology & Immunizations
Walter Reed National Military Medical Center
