Effect of Selenium Supplementation on Influenza Vaccination

Effect of Selenium Supplementation on Immunity Responses to 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.

Study Overview

• Status: Completed
• Conditions: Influenza Vaccination; Selenium Supplementation
• Intervention / Treatment: Dietary supplement: Selenium Supplementation; Biological: Influenza vaccination

Detailed Description

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

18-55 years, healthy subjects

Exclusion Criteria:

1. With the history of selenium supplementation as taking supplementation products or living more than 2 years in selenium-enriched area;
2. Had the symptoms of selenium toxicity or serum selenium level greater than 328 μg/L;
3. With the history of the administration of influenza vaccine in past three years or allergic to influenza vaccine;
4. With any current immunologic disorders, including autoimmune and allergic diseases;
5. With any cardiovascular, metabolic, mental, or psychological disorders;
6. Pregnancy or breastfeeding;
7. With the history of infectious diseases including airway infections in past three months;
8. Who are currently participating in other clinical studies or who have participated in other clinical research within 90 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selenium Supplementation; 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. Thirty days after the start of the supplementation, the subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.	Dietary supplement: Selenium Supplementation; 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.; Biological: Influenza vaccination; Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.
Other: Non-Selenium Supplementation; The control group will not receive selenium supplementation. Thirty days after allocation, the subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.	Biological: Influenza vaccination; Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	60 days
Immune cytokine IL-17A after selenium supplementation and vaccination	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).	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).	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).	60 days

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: The University of Queensland
• Investigators: Study Chair: Zheng Liu, Doctor, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: ENT-SELENIUM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No