Allergic Rhinitis Clinical Trial
Official title:
Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
NCT number | NCT05009134 |
Other study ID # | ENT-ALLERGY-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 4, 2021 |
Est. completion date | April 30, 2022 |
The study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 30, 2022 |
Est. primary completion date | March 20, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year Exclusion Criteria: 1. who infected with COVID-19 previously 2. Cannot finish the follow up 3. Previous allergic to other vaccines 4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection, 5. pregnancy or breastfeeding 6. Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study. |
Country | Name | City | State |
---|---|---|---|
China | Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Huazhong University of Science and Technology | National Natural Science Foundation of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay | Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay | Jun 2021-Aug 2021 | |
Primary | Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood | Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood | Jun 2021-Aug 2021 | |
Primary | Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA | Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA | Jun 2021-Aug 2021 |
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