Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The production of antigen-specific antibodies after vaccination
研究概览
简要总结
The study is designed to assess whether selenium supplementation can boost the immunity response to influenza vaccination in healthy adults. This is a randomized, prospective study enrolling a total of 60 healthy subjects, 18-55 years old.
详细描述
Background: Selenium is an essential trace element required for human health and wellbeing. Despite mouse studies and human clinical trial suggest selenium supplementation might enhance immunity, little is known for the effects of selenium supplementation on humoral immunity. Vaccination is the most effective medical intervention to prevent infections and to reduce disability and mortality associated with infectious disease. However, some individuals, in healthy or disease conditions, mount less effective humoral immune responses to vaccination. Therefore, new strategy to enhance humoral immunity upon vaccination is highly sought after. Using mouse models, we have observed that selenium supplementation significantly increased antigen-specific antibody responses. Thus, we hypothesize that selenium supplementation may be beneficial in enhancing humoral immunity in humans.
Objectives: To investigate whether selenium supplementation will boost the humoral response to influenza vaccination in healthy adults.
Design and trial size: This is a randomized prospective study. A total of 60 healthy subjects, 18-55 years old, will be enrolled in this study.
Intervention and duration: The enrolled subjects will be randomized into selenium supplementation and control group. The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days. The control group will not receive selenium supplementation. Thirty days after allocation, both groups will receive standard seasonal influenza vaccination for the 2019-2020 season. Peripheral blood samples will be collected at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years, healthy subjects
排除标准
- •With the history of selenium supplementation as taking supplementation products or living more than 2 years in selenium-enriched area;
- •Had the symptoms of selenium toxicity or serum selenium level greater than 328 μg/L;
- •With the history of the administration of influenza vaccine in past three years or allergic to influenza vaccine;
- •With any current immunologic disorders, including autoimmune and allergic diseases;
- •With any cardiovascular, metabolic, mental, or psychological disorders;
- •Pregnancy or breastfeeding;
- •With the history of infectious diseases including airway infections in past three months;
- •Who are currently participating in other clinical studies or who have participated in other clinical research within 90 days
结局指标
主要结局
The production of antigen-specific antibodies after vaccination
时间窗: 60 days
Viral strain-specific antibodies in serum at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination) will be measured by hemagglutination inhibition (HAI) assay
次要结局
- Immune cell responses after selenium supplementation and vaccination(60 days)
- Immune cytokine IFN-γ after selenium supplementation and vaccination(60 days)
- Immune cytokine IL-4 after selenium supplementation and vaccination(60 days)
- Immune cytokine IL-10 after selenium supplementation and vaccination(60 days)
- Immune cytokine IL-17A after selenium supplementation and vaccination(60 days)
- Immune cytokine IL-21 after selenium supplementation and vaccination(60 days)
- Selenium levels after selenium supplementation and vaccination(60 days)
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery, Deputy Dean of The Second Clinical Medical School,Deputy Dean of Tongji Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology