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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | 18-55 years, healthy |
| |
| Allergic rhinitis | patients with AR without AIT |
| |
| Allergen immunotherapy | patients with AR with AIT for more than 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention in this study. | Biological | There is no intervention in this study. |
|
| 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 |
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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:
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18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Liu, Doctor | Contact | 86 027 83663807 | zhengliuent@hotmail.com | |
| Rong-Fei Zhu, Doctor | Contact | zrf13092@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Liu, Doctor | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36655976 | Derived | Gao X, Luo K, Wang D, Wei Y, Yao Y, Deng J, Yang Y, Zeng Q, Dong X, Xiong L, Gong D, Lin L, Pohl K, Liu S, Liu Y, Liu L, Nguyen THO, Allen LF, Kedzierska K, Jin Y, Du MR, Chen W, Lu L, Shen N, Liu Z, Cockburn IA, Luo W, Yu D. T follicular helper 17 (Tfh17) cells are superior for immunological memory maintenance. Elife. 2023 Jan 19;12:e82217. doi: 10.7554/eLife.82217. | |
| 35649178 |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine.
| Yao Y, Huang A, Deng YK, Liu Y, Zhu HY, Wang N, Wang ZZ, Zhu RF, Yu D, Liu Z. Allergen Immunotherapy Reverses Immune Response to SARS-CoV-2 Vaccine in Patients with Allergic Rhinitis: A Prospective Observational Trial. Am J Respir Crit Care Med. 2022 Sep 15;206(6):780-783. doi: 10.1164/rccm.202203-0608LE. No abstract available. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |