Influenza Vaccination Clinical Trial
Official title:
Effect of Selenium Supplementation on Immunity Responses to Influenza Vaccination
Verified date | February 2020 |
Source | Huazhong University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Huazhong University of Science and Technology | The University of Queensland |
China,
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 |
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