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Completed

NCT Number: NCT04188483

Effect of Selenium Supplementation on Influenza Vaccination

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-55 years, healthy subjects

Exclusion criteria

  • 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

Treatment and study plan

Selenium Supplementation

Dietary Supplement

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.

Influenza vaccination

Biological

Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.

Primary outcomes

  1. The production of antigen-specific antibodies after vaccination

    Time frame: 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

Secondary outcomes

  1. Immune cell responses after selenium supplementation and vaccination

    Time frame: 60 days

    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.

  2. Immune cytokine IFN-γ after selenium supplementation and vaccination

    Time frame: 60 days

    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).

  3. Immune cytokine IL-4 after selenium supplementation and vaccination

    Time frame: 60 days

    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).

  4. Immune cytokine IL-10 after selenium supplementation and vaccination

    Time frame: 60 days

    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).

  5. Immune cytokine IL-17A after selenium supplementation and vaccination

    Time frame: 60 days

    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).

  6. Immune cytokine IL-21 after selenium supplementation and vaccination

    Time frame: 60 days

    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).

  7. Selenium levels after selenium supplementation and vaccination

    Time frame: 60 days

    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).

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • The University of Queensland

Registry information

Official study title

Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 6, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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