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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
60
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.
Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The production of antigen-specific antibodies after vaccination
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
Time frame: 60 days
Immune cell responses after selenium supplementation and vaccination
Frequencies (%) of immune cells including T cells, B cells, monocytes, dendritic cells, NK cells in peripheral blood 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 flow cytometry.
Time frame: 60 days
Immune cytokine IFN-γ after selenium supplementation and vaccination
Levels of IFN-γ in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Time frame: 60 days
Immune cytokine IL-4 after selenium supplementation and vaccination
Levels of IL-4 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Time frame: 60 days
Immune cytokine IL-10 after selenium supplementation and vaccination
Levels of IL-10 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Time frame: 60 days
Immune cytokine IL-17A after selenium supplementation and vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Levels of IL-17A in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Time frame: 60 days
Immune cytokine IL-21 after selenium supplementation and vaccination
Levels of IL-21 in plasma 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 enzyme-linked immunosorbent assay (ELISA).
Time frame: 60 days
Selenium levels after selenium supplementation and vaccination
Level of selenium in plasma 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 inductively coupled plasma mass spectrometry (ICP-MS).
Time frame: 60 days