Effect of Selenium Supplementation on Influenza Vaccination

Influenza Vaccination Clinical Trial

Official title:

Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188483
• Other study ID #: ENT-SELENIUM-01
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza Vaccination
• Influenza, Human
• Selenium Supplementation

Intervention

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.

Locations

Country	Name	City	State
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	The University of Queensland

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Immune cytokine IFN-? after selenium supplementation and vaccination	Levels of IFN-? 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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