Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
排除标准
- •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.
结局指标
主要结局
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
时间窗: Jun 2021-Aug 2021
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
时间窗: Jun 2021-Aug 2021
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
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
时间窗: 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
次要结局
未报告次要终点
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery, Deputy Dean of Tongji Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology