Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Antibodies against hepatitis A virus (anti-HAV)
研究概览
简要总结
The purpose of this study is to access whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment.
详细描述
Sleep regulates immune functions. In this sense, we asked whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment. Men (18 to 55 years) will be recruited through different forms of media (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected to assess the humoral response in the experimental groups. The hormones prolactin, growth hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations in culture will be conducted to assess the cellular response profile against the vaccination through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •shift workers
- •naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL
排除标准
- •individuals with complaints and/or sleep disorders
- •acute or chronic disease
- •use of medication during the study period.
- •acute illnesses
研究组 & 干预措施
Shiftwork
The comparison will consider nightworkers versus dayworkers.
干预措施: Vaccination against hepatitis A (Biological)
Shiftwork
The comparison will consider nightworkers versus dayworkers.
干预措施: No Intervention (Other)
结局指标
主要结局
Antibodies against hepatitis A virus (anti-HAV)
时间窗: Baseline, 30 days, 60 days and 90 days
Change in antibodies against hepatitis A virus (anti-HAV) production
次要结局
- Catecholamines(Baseline, 30 days, 60 days and 90 days)
- Cortisol(Baseline, 30 days, 60 days and 90 days)
- Intracellular cytokines(Baseline, 30 days, 60 days and 90 days)
- Growth hormone(Baseline, 30 days, 60 days and 90 days)
- Sleep disorders(Baseline)
- Prolactin(Baseline, 30 days, 60 days and 90 days)
研究者
Marco Tulio de Mello
Associate Professor
Federal University of São Paulo