Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: Allergic rhinitis (AR) is a disorder caused by hypersensitivity of the immune system to harmless allergens in the environment, which represents a global public health problem affecting up to 20-50% of the population. Allergen immunotherapy (AIT) is the only effective treatment that not only has disease-modifying property but also confers long-term clinical benefit after cessation of treatment for AR patients. Vaccination is one of the most powerful interventions for reducing disability and death caused by infectious disease. Immunization with the inactivated SARS-CoV-2 Vaccine remains the most effective strategy to combat COVID-19 infections. Nevertheless, the influences of allergic rhinitis and allergen immunotherapy on SARS-CoV-2 vaccination are still unknown. Objectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults. Design and trial size: This is a prospective study. A total of approximately 120 subjects, 18-55 years old, including 40 healthy subjects, 40 patients with AR without AIT, and 40 patients with AR with AIT for more than 1 year, will be enrolled in this study. Intervention and duration: All of the study participants will be vaccinated with an 2 doses inactivated vaccine against SARS-CoV-2 (COVILO). Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine. One-month additional data analysis leads to the trial duration of 3 months.

Official Title
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Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination

Conditions
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Allergic Rhinitis, Allergen Immunotherapy, SARS-CoV-2

Intervention / Treatment
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* Biological: There is no intervention in this study.


Participation Criteria
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Eligibility Criteria
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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: who infected with COVID-19 previously Cannot finish the follow up Previous allergic to other vaccines who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection, pregnancy or breastfeeding Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>18-55 years, healthy | Biological: There is no intervention in this study.<br>* There is no intervention in this study.<br>|
| Allergic rhinitis<br>patients with AR without AIT | Biological: There is no intervention in this study.<br>* There is no intervention in this study.<br>|
| Allergen immunotherapy<br>patients with AR with AIT for more than 1 year | Biological: There is no intervention in this study.<br>* There is no intervention in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA | Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA | Jun 2021-Aug 2021 |